Back Pain Lower Back
Conditions
Keywords
NSAIDS (Nonsteroidal anti-inflammatory drugs), Exercise, Physiotherapy, Subacute Low Back Pain, Pain, Visual Analogue Scale, oswesrty, Roland Morris, SF-36, Quality of life
Brief summary
Our clinical trial has the purpose to evaluate the effectiveness in reducing pain and improving function and quality of life during a 6-months follow-up of a therapeutic exercise program compared to pharmacological treatment with NSAIDs in patients with subacute low back pain attending the physiatrist consultation of several ambulatory health centers in Medellín during the years 2009-2010.
Detailed description
General Purpose To evaluate the effectiveness in reducing pain and improving function and quality of life during a 6-months follow-up of a therapeutic exercise program compared to pharmacological treatment with NSAIDs in patients with subacute low back pain attending the physiatrist consultation of several ambulatory health centers in Medellín during the years 2009-2010. Specific Objectives 1. To evaluate the efficacy of a protocolized exercise program in reducing low back pain. 2. To evaluate the efficacy of a protocolized exercise program in improving the function. 3. To compare the effects of both interventions on quality of life and work absenteeism in the two groups of patients. 4. To compare the safety of both interventions. 5. To estimate adherence and causes of non-adherence of patients to different treatments proposed. 6. To compare in both groups the number of relapses, general and specialized medical consultations, screening studies, images and other treatments associated with low back pain. Null Hypothesis Management of subacute low back pain patients with a protocolized exercise program is not more effective than treatment with NSAIDs to reduce pain at least in 25 mm, measured with a Visual Analog Scale 0-100 mm. Alternative hypothesis Management of subacute low back pain patients with a protocolized exercise program is not more effective than treatment with NSAIDs to reduce pain at least in 25 mm, measured with a Visual Analog Scale 0-100 mm. Methodology: Type of study: randomized controlled clinical trial, single-blinded with independent evaluators. Reference population: Patients consulting physiatrists in different physical medicine and rehabilitation departments in Medellin, Colombia. Study population: patients with subacute low back pain -evolution time more than 6 weeks and less than 3 months-, with or without radiculopathy, and that fulfill inclusion criteria. In addition patients must sign an informed consent to participate in research. Inclusion criteria: * Patients aged between 18 and 60 years with subacute low back pain. * Evolution time more than 6 weeks and less than 3 months. * That were included in the social security system and live in the metropolitan area. Exclusion criteria: * Antecedents of spinal, pelvis or abdominal trauma. * Cancer. * Diabetes mellitus. * Steroid use. * Women over 60 years. * Cauda equine syndrome. * Men with osteoporosis or compression fractures. * Suspicion of infection * Insidious onset * Constitutional symptoms * Intravenous drugs abuse * HIV * Immunosuppression * Previous surgery * Rheumatic diseases * Urinary tract infections * Neurological symptoms in lower limbs * Mental illness (schizophrenia, bipolar or somatomorphic disorder, major depression) * Deformities in the spine (scoliosis greater than 15º) * History of peptic acid disease * Renal failure * Intake of anticoagulants or antiplatelet drugs * Allergy to NSAIDs. Primary outcome Pain relief more than 25 mm on the Visual Analogue Scale, ranging from 0 to 100, assessed 4 weeks after intervention. Secondary outcomes: Improvement in function assessed by the Oswestry Disability Index and Roland-Morris questionnaire comparing baseline to first, three and six months follow-up. Improvement in quality of life assessed by SF-36 (The Short Form Health Survey) questionnaire at baseline and at first, third and sixth months. Work absenteeism decrease. Decrease in the number of relapses, general and specialized medical consultations, screening studies, images and other treatments associated with low back pain at 6 months. Safety of both treatments evaluated in the exercise group by tolerance to training and presence or not of side effects, and in the NSAIDs group by the presence or absence of adverse reactions. Sample: Sampling type: simple random. Sample size calculation was based on software Sample size Javeriana University Type I error: 0.05 Type II Error: 0.2 Assessments number prior to randomization: 1 Assessments number after randomization: 3 Correlation between evaluations: 0.8 Clinically important difference: 0.33 Number of patients per group: 33 Experimental group control group ratio : 1 to 1 10% of loss: 7 Total: 73 Randomization Randomization was done by means of permuted blocks of size 2, 4 and 6, generated by computer (Ralloc program, co Stata 8.2, College Station, TX, USA). Allocation will be confidential and will not be opened until the investigation is completed, this will be monitored by the Committee of Data Security. Enrollment Patients with subacute low back pain consulting Physical Medicine and Rehabilitation Departments of hospitals in Medellín, Colombia. There will be an initial assessment, and if patient is considered eligible will be invited to participate and asked to sign an informed consent (Appendix 1). Treatment assignment will be given in an opaque envelope. Masking Medical researchers who evaluate the patients, research assistants who perform the application of different measure instruments and statistical will be blinded to treatment allocation. Initial assessment Clinical evaluation will be performed by one of the research physiatrists. Evaluation will include: epidemiological and clinical, Visual Analog Scale (VAS), Oswestry scale, Rolland Morris Scale, and SF-36 quality of life scale. Intervention One group will be assigned to protocolized back pain exercise, three times a week for 4 weeks. This program is carried out by physiotherapists from participating institutions who wish to participate in research and who will be given a training which will standardize the intervention programs Exercise program includes: physical agents, massage of myofascial points, stretching and strengthening exercises, cycloergometer or band aerobic exercises. Treatment, type of exercises, exercise tolerance and adverse reactions will be registered. The second group will receive NSAID for 10 days, there will be two different options (naproxen or celecoxib) according to indications and contraindications. In case of increase in pain intensity in either of the two groups, acetaminophen in doses of 1.5 to 2.0 g / day will be used as a rescue. Adherence to different treatments. To ensure adherence to different treatments each patient will receive a phone call weekly to inquire about assistance, difficulties, tolerance, use of medications, and adverse effects. Patients will be given a questionnaire to verify drugs intake, dosage, time and side effects. They should also register any other drug ingestion. Telephone calls will be made every 15 days to ask about the health status and ensuring assistance to new assessments. Assessment will be scheduled at 1, 3, and 6 months Clinical evaluation will be performed by one of the researcher physiatrists or a postgraduate student. Committee of safety and quality of data. This committee will consist of two researchers and one professional information management responsible for the database. This will be done in Access and SPSS 15 (Statistical Product and Service Solutions) before starting information recollection. Analysis Plan Categorical univariate variables will be analyzed by frequency distributions and quantitative variables by measures of central tendency (mean, standard deviation, median or range). Both groups will be compared after randomization and before intervention for all variables. Initially, it will be established for each group if the quantitative variables are of normal distribution, by using the Kolmogorov-Smirnov test. Pain (primary outcome) will be evaluated in each patient at 1, 3 and 6 months and will be compared with initial pain (mean and confidence intervals) by using Student t test or Mann Whitney for each time period. The same procedure would be for the other outcomes measured quantitatively. An analysis of variance with repeated measures for the variability between groups and intragroup will be made. Comparison of categorical variables at each assessment will be done using the Chi2 test. The level of statistical significance to be used in all cases is 0.05. An analysis by intention to treat and per protocol will be made. Ethics This research and informed consent is according to Scientific, technical and administrative standards for health research of the Ministry of Health and the Decree 309 of 2000 of the Ministry of Environment. This is considered a minimal risk research, because therapeutic interventions are widely used to treat patients with these conditions.
Interventions
OTHERExercise program
Standardize the intervention programs Exercise program includes: physical agents, massage of myofascial points, stretching and strengthening exercises, cycloergometer or band aerobic exercises. 12 sessions, 3 per week.
The second group was treated for 10 days with NSAIDs (naproxen 500 mg/d or celecoxib 200 mg/d) according to the indications and contraindications. The patients kept a journal stating whether they had taken the drug and any adverse reactions. If the pain intensity of any participant increased, acetaminophen (1.5 - 2.0 g/d) was proposed as a rescue procedure.
Sponsors
Universidad de Antioquia
Grupo Rehabilitacion en Salud
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
TRIPLE (Subject, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to 60 Years
Healthy volunteers
No
Inclusion criteria
* Patients aged between 18 and 60 years old * Subacute low back pain -evolution time more than 4 weeks and less than 3 months. * That have social security system * Live in the metropolitan area
Exclusion criteria
* Antecedents of spinal, pelvis or abdominal trauma * Cancer * Diabetes mellitus * Steroids use * Men and Women over 60 years * Cauda equine syndrome * Women and men with osteoporosis or compression fractures * Suspicion of infection. * Insidious onset, constitutional symptoms * Intravenous drugs abuse * HIV * Immunosuppression or previous surgery * Rheumatic diseases * Urinary tract infections * Neurological symptoms in lower limbs * Mental illness (schizophrenia, bipolar or somatomorphic disorder, major depression) * Deformities in the spine (scoliosis greater than 15º) * History of peptic acid disease * Renal failure * Intake of anticoagulants or antiplatelet drugs * Allergy to NSAIDs.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Visual Analogue Scale of Pain | At the beginning | In the Visual Analogue Sacale the best result is 0 and the worst is 100, The primary outcome was pain the mesurement of the Visual Analog Scale (VAS) (0 \[no pain\] to 100 \[maximum pain\]) at the beginning. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Roland-Morris Questionnaire | At the beginning | Improvement in function assessed by the Roland-Morris questionnaire, a widely used health status measure for low back pain. The RMDQ can be used in research or clinical practice. Scoring the RMDQ. The RMDQ is scored by adding up the number of items checked by the patient. The score can therefore vary from 0 to 24. It is not recommended to give patients a 'Yes' / 'No' option. If patients indicate in any way that an item is not applicable to them, the item is scored 'No', i.e. the denominator remains 24. Being worst 24. |
| Quality of Life, Change in Health | At the beginning | Improvement in Quality of life was assessed with the SF-36 questionnaire, which ranges from 0 to 100 being 100 the best quality of life. The Short Form (36) Health Survey is a patient-reported survey of patient health. The SF-36 consists of eight scaled scores, which are the weighted sums of the questions in their section. Each scale is directly transformed into a 0-100 scale on the assumption that each question carries equal weight. The lower the score the more disability. The higher the score the less disability i.e. a score of zero is equivalent to maximum disability and a score of 100 is equivalent to no disability. This outcome shows the subdomain data: change in health. |
| Quality of Life, Bodily Pain | At the beginning | Improvement in Quality of life was assessed with the SF-36 questionnaire, which ranges from 0 to 100 being 100 the best quality of life. The Short Form (36) Health Survey is a patient-reported survey of patient health. The SF-36 consists of eight scaled scores, which are the weighted sums of the questions in their section. Each scale is directly transformed into a 0-100 scale on the assumption that each question carries equal weight. The lower the score the more disability. The higher the score the less disability i.e. a score of zero is equivalent to maximum disability and a score of 100 is equivalent to no disability. This outcome shows the subdomain data: bodily pain. |
| Quality of Life, Emotional Performance. | At the beginning | Improvement in Quality of life was assessed with the SF-36 questionnaire, which ranges from 0 to 100 being 100 the best quality of life. The Short Form (36) Health Survey is a patient-reported survey of patient health. The SF-36 consists of eight scaled scores, which are the weighted sums of the questions in their section. Each scale is directly transformed into a 0-100 scale on the assumption that each question carries equal weight. The lower the score the more disability. The higher the score the less disability i.e. a score of zero is equivalent to maximum disability and a score of 100 is equivalent to no disability. This outcome shows the subdomain data: Emotional Performance. |
| Quality of Life, Physical Performance. | At the beginning | Improvement in Quality of life was assessed with the SF-36 questionnaire, which ranges from 0 to 100 being 100 the best quality of life. The Short Form (36) Health Survey is a patient-reported survey of patient health. The SF-36 consists of eight scaled scores, which are the weighted sums of the questions in their section. Each scale is directly transformed into a 0-100 scale on the assumption that each question carries equal weight. The lower the score the more disability. The higher the score the less disability i.e. a score of zero is equivalent to maximum disability and a score of 100 is equivalent to no disability. This outcome shows the subdomain data: Physical Performance |
| Quality of Life, Physical Function. | At the beginning | Improvement in Quality of life was assessed with the SF-36 questionnaire, which ranges from 0 to 100 being 100 the best quality of life. The Short Form (36) Health Survey is a patient-reported survey of patient health. The SF-36 consists of eight scaled scores, which are the weighted sums of the questions in their section. Each scale is directly transformed into a 0-100 scale on the assumption that each question carries equal weight. The lower the score the more disability. The higher the score the less disability i.e. a score of zero is equivalent to maximum disability and a score of 100 is equivalent to no disability. This outcome shows the subdomain data: Physical Function. |
| Quality of Life, Social Function. | At the beginning | Improvement in Quality of life was assessed with the SF-36 questionnaire, which ranges from 0 to 100 being 100 the best quality of life. The Short Form (36) Health Survey is a patient-reported survey of patient health. The SF-36 consists of eight scaled scores, which are the weighted sums of the questions in their section. Each scale is directly transformed into a 0-100 scale on the assumption that each question carries equal weight. The lower the score the more disability. The higher the score the less disability i.e. a score of zero is equivalent to maximum disability and a score of 100 is equivalent to no disability. This outcome shows the subdomain data: Social Function. |
| Oswestry Disability Index | At the beginning | Function was assessed using the Oswestry Disability Index questionnaire Version 2.1a, which ranges from 0 to 100 (greater disability), being worst 100. The Oswestry Disability Index is currently considered by many as the gold standard for measuring degree of disability and estimating quality of life in a person with low back pain. 0% to 20%: Minimal disability, 21%-40%: Moderate Disability, 41%-60%: Severe Disability, 61%-80%: Crippling back pain, 81%-100%: These patients are either bed-bound or have an exaggeration of their symptoms. |
| Quality of Life, Mental Health. | At the beginning | Improvement in Quality of life was assessed with the SF-36 questionnaire, which ranges from 0 to 100 being 100 the best quality of life. The Short Form (36) Health Survey is a patient-reported survey of patient health. The SF-36 consists of eight scaled scores, which are the weighted sums of the questions in their section. Each scale is directly transformed into a 0-100 scale on the assumption that each question carries equal weight. The lower the score the more disability. The higher the score the less disability i.e. a score of zero is equivalent to maximum disability and a score of 100 is equivalent to no disability. This outcome shows the subdomain data: Mental Health. |
| Quality of Life, Vitality. | At the beginning | Improvement in Quality of life was assessed with the SF-36 questionnaire, which ranges from 0 to 100 being 100 the best quality of life. The Short Form (36) Health Survey is a patient-reported survey of patient health. The SF-36 consists of eight scaled scores, which are the weighted sums of the questions in their section. Each scale is directly transformed into a 0-100 scale on the assumption that each question carries equal weight. The lower the score the more disability. The higher the score the less disability i.e. a score of zero is equivalent to maximum disability and a score of 100 is equivalent to no disability. This outcome shows the subdomain data: Vitality. |
| PHQ-9 Patient Health Questionnaire (PHQ-9) Depression | 4 weeks | Depression was measured with the Patient Health Questionnaire (PHQ-9), which ranged from 0 (no depression) to 27 (severe depression). |
| Relapses of Lumbar Pain | 12 weeks | The percentage of patients with relapsed of low back pain was measured. |
| Treatments Associated With Low Back Pain at 6 Months | 6 months | we are showing in this result, the number of patients who had to receive any additional treatment in either group. The measure is the number of participants who received additional treatment throughout the duration of the study. |
| Missing Workdays | 6 weeks before starting | This result shows the average of the number of missed work days. |
| Medical Consultations. | 4 weeks | This result shows, the total number of participants received additional medical consultations. |
| Quality of Life, General Health Perceptions. | At the beginning | Improvement in Quality of life was assessed with the SF-36 questionnaire, which ranges from 0 to 100 being 100 the best quality of life. The Short Form (36) Health Survey is a patient-reported survey of patient health. The SF-36 consists of eight scaled scores, which are the weighted sums of the questions in their section. Each scale is directly transformed into a 0-100 scale on the assumption that each question carries equal weight. The lower the score the more disability. The higher the score the less disability i.e. a score of zero is equivalent to maximum disability and a score of 100 is equivalent to no disability. This outcome shows the subdomain data: General Health Perceptions. |
Countries
Colombia
Participant flow
Recruitment details
Patients (18 and 60 years) with SLBP (subacute low back pain) (lasting 4-12 weeks) with or without radiculopathy who were assigned to the social security system and living in the metropolitan area were included.
Pre-assignment details
A specific cause for the pain (infection, tumor, ankylosing spondylitis, inflammatory conditions or cauda equine syndrome), the presence of red flags, scoliosis \>15 °, depression or mental illness, history of gastrointestinal bleeding, renal failure, intake of anticoagulants or antiplatelet drugs and NSAID allergy were excluded.
Participants by arm
| Arm | Count |
|---|---|
| Excercise One group will be assigned to protocolized back pain exercise, three times a week for 4 weeks. This program is carried out by physiotherapists from participating institutions who wish to participate in research and who will be given a training which will standardize the intervention programs Exercise program includes: physical agents, massage of myofascial points, stretching and strengthening exercises, cycloergometer or band aerobic exercises. Treatment, type of exercises, exercise tolerance and adverse reactions will be registered
Exercise program : Standardize the intervention programs Exercise program includes: physical agents, massage of myofascial points, stretching and strengthening exercises, cycloergometer or band aerobic exercises. 12 sessions, 3 per week. | 46 |
| NSAID Naproxen 500 mg per day by 10 days or Celecoxib 200 mg per day by 10 days and Acetaminophen 1,5 a 2 g as rescue
NSAID : The second group was treated for 10 days with NSAIDs (naproxen 500 mg/d or celecoxib 200 mg/d) according to the indications and contraindications. The patients kept a journal stating whether they had taken the drug and any adverse reactions. If the pain intensity of any participant increased, acetaminophen (1.5 - 2.0 g/d) was proposed as a rescue procedure. | 44 |
| Total | 90 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Overall Study | closed research | 1 | 2 |
| Overall Study | Lost to Follow-up | 1 | 3 |
| Overall Study | Withdrawal by Subject | 4 | 0 |
Baseline characteristics
| Characteristic | Excercise | NSAID | Total |
|---|---|---|---|
| Age, Continuous | 38.5 years STANDARD_DEVIATION 12.3 | 40.3 years STANDARD_DEVIATION 13.2 | 39.4 years STANDARD_DEVIATION 12.74 |
| Region of Enrollment Colombia | 46 participants | 44 participants | 90 participants |
| Sex: Female, Male Female | 37 Participants | 33 Participants | 70 Participants |
| Sex: Female, Male Male | 9 Participants | 11 Participants | 20 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — |
| other Total, other adverse events | 0 / 46 | 14 / 44 |
| serious Total, serious adverse events | 0 / 46 | 0 / 44 |
Outcome results
Primary
Visual Analogue Scale of Pain
In the VAS the best result is 0 and the worst is 100. The primary outcome was pain improvement of ≥25 mm on the Visual Analog Scale (VAS) (0 \[no pain\] to 100 \[maximum pain\]) at 12 weeks.
Time frame: 12 weeks
Population: We lost 4 patients in arm exercise because we ran out of time limit for the investigation and could not evaluate them. And we lost 4 in arm NSAIDs, 3 who did not answer our calls and 1 for close investigation.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Excercise | Visual Analogue Scale of Pain | 21.0 units on a scale | Standard Deviation 24.4 |
| NSAID | Visual Analogue Scale of Pain | 20.6 units on a scale | Standard Deviation 17.2 |
Primary
Visual Analogue Scale of Pain
The best result is 0 and the worst is 100, Pain relief more than 25 mm on the Visual Analogue Scale, assessed 24 weeks after intervention.
Time frame: 24 weeks
Population: We lost 2 patients in arm exercise 1 because we ran out of time limit for the investigation and could not evaluate them and 1 who did not answer our calls . In the NSAIDs arm we recover 3 patients who did not answer the call for three months evaluation, and lost 4 for deadline of the investigation.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Excercise | Visual Analogue Scale of Pain | 17.8 units on a scale | Standard Deviation 21.8 |
| NSAID | Visual Analogue Scale of Pain | 17.5 units on a scale | Standard Deviation 18.1 |
Primary
Visual Analogue Scale of Pain
In the Visual Analogue Sacale the best result is 0 and the worst is 100, The primary outcome was pain the mesurement of the Visual Analog Scale (VAS) (0 \[no pain\] to 100 \[maximum pain\]) at the beginning.
Time frame: At the beginning
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Excercise | Visual Analogue Scale of Pain | 47.3 units on a scale | Standard Deviation 19.8 |
| NSAID | Visual Analogue Scale of Pain | 45.2 units on a scale | Standard Deviation 22.6 |
Primary
Visual Analogue Scale of Pain
In the VAS the best result is 0 and the worst is 100. The primary outcome was pain improvement of ≥25 mm on the Visual Analog Scale (VAS) (0 \[no pain\] to 100 \[maximum pain\]) at 4 weeks.
Time frame: 4 weeks
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Excercise | Visual Analogue Scale of Pain | 28.8 units on a scale | Standard Deviation 20.5 |
| NSAID | Visual Analogue Scale of Pain | 34.9 units on a scale | Standard Deviation 25 |
Secondary
Medical Consultations.
This result shows, the total number of participants received additional medical consultations.
Time frame: 4 weeks
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Excercise | Medical Consultations. | 4 participants |
| NSAID | Medical Consultations. | 6 participants |
Secondary
Medical Consultations.
This result shows, the total number of participants received additional medical consultations.
Time frame: 24 weeks
Population: We lost 2 patients in arm exercise 1 because we ran out of time limit for the investigation and could not evaluate them and 1 who did not answer our calls . In the NSAIDs arm we recover 3 patients who did not answer the call for three months evaluation, and lost 4 for deadline of the investigation.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Excercise | Medical Consultations. | 4 participants |
| NSAID | Medical Consultations. | 4 participants |
Secondary
Medical Consultations.
This result shows, the total number of participants received additional medical consultations.
Time frame: 12 weeks
Population: We lost 4 patients in arm exercise because we ran out of time limit for the investigation and could not evaluate them. And we lost 4 in arm NSAIDs, 3 who did not answer our calls and 1 for close investigation.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Excercise | Medical Consultations. | 1 participants |
| NSAID | Medical Consultations. | 6 participants |
Secondary
Missing Workdays
This result shows the average of the number of missed work days.
Time frame: 12 weeks
Population: We lost 4 patients in arm exercise because we ran out of time limit for the investigation and could not evaluate them. And we lost 4 in arm NSAIDs, 3 who did not answer our calls and 1 for close investigation.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Excercise | Missing Workdays | 0.0 Days | Standard Deviation 0.4 |
| NSAID | Missing Workdays | 0.1 Days | Standard Deviation 0.6 |
Secondary
Missing Workdays
This result shows the average of the number of missed work days.
Time frame: 24 weeks
Population: We lost 2 patients in arm exercise 1 because we ran out of time limit for the investigation and could not evaluate them and 1 who did not answer our calls . In the NSAIDs arm we recover 3 patients who did not answer the call for three months evaluation, and lost 4 for deadline of the investigation.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Excercise | Missing Workdays | 0.2 Days | Standard Deviation 0.7 |
| NSAID | Missing Workdays | 0.2 Days | Standard Deviation 0.9 |
Secondary
Missing Workdays
This result shows the average of the number of missed work days.
Time frame: 6 weeks before starting
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Excercise | Missing Workdays | 1.0 Days | Standard Deviation 2.9 |
| NSAID | Missing Workdays | 1.7 Days | Standard Deviation 6.2 |
Secondary
Missing Workdays
This result shows the average of the number of missed work days.
Time frame: 4 weeks
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Excercise | Missing Workdays | 0.0 Days | Standard Deviation 0 |
| NSAID | Missing Workdays | 0.3 Days | Standard Deviation 1.6 |
Secondary
Oswestry Disability Index
Function was assessed using the Oswestry Disability Index questionnaire Version 2.1a, which ranges from 0 to 100 (greater disability), being worst 100. The Oswestry Disability Index is currently considered by many as the gold standard for measuring degree of disability and estimating quality of life in a person with low back pain. 0% to 20%: Minimal disability, 21%-40%: Moderate Disability, 41%-60%: Severe Disability, 61%-80%: Crippling back pain, 81%-100%: These patients are either bed-bound or have an exaggeration of their symptoms.
Time frame: 12 weeks
Population: We lost 4 patients in arm exercise because we ran out of time limit for the investigation and could not evaluate them. And we lost 4 in arm NSAIDs, 3 who did not answer our calls and 1 for close investigation.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Excercise | Oswestry Disability Index | 16.6 units on a scale | Standard Deviation 13.2 |
| NSAID | Oswestry Disability Index | 19.4 units on a scale | Standard Deviation 13.7 |
Secondary
Oswestry Disability Index
Function was assessed using the Oswestry Disability Index questionnaire Version 2.1a, which ranges from 0 to 100 (greater disability), being worst 100. The Oswestry Disability Index is currently considered by many as the gold standard for measuring degree of disability and estimating quality of life in a person with low back pain. 0% to 20%: Minimal disability, 21%-40%: Moderate Disability, 41%-60%: Severe Disability, 61%-80%: Crippling back pain, 81%-100%: These patients are either bed-bound or have an exaggeration of their symptoms.
Time frame: 24 weeks
Population: We lost 2 patients in arm exercise 1 because we ran out of time limit for the investigation and could not evaluate them and 1 who did not answer our calls . In the NSAIDs arm we recover 3 patients who did not answer the call for three months evaluation, and lost 4 for deadline of the investigation.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Excercise | Oswestry Disability Index | 13.8 units on a scale | Standard Deviation 12.2 |
| NSAID | Oswestry Disability Index | 17.2 units on a scale | Standard Deviation 14 |
Secondary
Oswestry Disability Index
Function was assessed using the Oswestry Disability Index questionnaire Version 2.1a, which ranges from 0 to 100 (greater disability), being worst 100. The Oswestry Disability Index is currently considered by many as the gold standard for measuring degree of disability and estimating quality of life in a person with low back pain. 0% to 20%: Minimal disability, 21%-40%: Moderate Disability, 41%-60%: Severe Disability, 61%-80%: Crippling back pain, 81%-100%: These patients are either bed-bound or have an exaggeration of their symptoms.
Time frame: At the beginning
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Excercise | Oswestry Disability Index | 28.9 units on a scale | Standard Deviation 13.1 |
| NSAID | Oswestry Disability Index | 29.4 units on a scale | Standard Deviation 15.1 |
Secondary
Oswestry Disability Index
Function was assessed using the Oswestry Disability Index questionnaire Version 2.1a, which ranges from 0 to 100 (greater disability), being worst 100. The Oswestry Disability Index is currently considered by many as the gold standard for measuring degree of disability and estimating quality of life in a person with low back pain. 0% to 20%: Minimal disability, 21%-40%: Moderate Disability, 41%-60%: Severe Disability, 61%-80%: Crippling back pain, 81%-100%: These patients are either bed-bound or have an exaggeration of their symptoms.
Time frame: 4 weeks
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Excercise | Oswestry Disability Index | 21.9 units on a scale | Standard Deviation 12.6 |
| NSAID | Oswestry Disability Index | 26.6 units on a scale | Standard Deviation 18.5 |
Secondary
PHQ-9 Patient Health Questionnaire (PHQ-9) Depression
Depression was measured with the Patient Health Questionnaire (PHQ-9), which ranged from 0 (no depression) to 27 (severe depression).
Time frame: 12 weeks
Population: We lost 4 patients in arm exercise because we ran out of time limit for the investigation and could not evaluate them. And we lost 4 in arm NSAIDs, 3 who did not answer our calls and 1 for close investigation.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Excercise | PHQ-9 Patient Health Questionnaire (PHQ-9) Depression | 3.0 units on a scale | Standard Deviation 3.1 |
| NSAID | PHQ-9 Patient Health Questionnaire (PHQ-9) Depression | 3.2 units on a scale | Standard Deviation 2.7 |
Secondary
PHQ-9 Patient Health Questionnaire (PHQ-9) Depression
Depression was measured with the Patient Health Questionnaire (PHQ-9), which ranged from 0 (no depression) to 27 (severe depression).
Time frame: 4 weeks
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Excercise | PHQ-9 Patient Health Questionnaire (PHQ-9) Depression | 3.9 units on a scale | Standard Deviation 4 |
| NSAID | PHQ-9 Patient Health Questionnaire (PHQ-9) Depression | 3.4 units on a scale | Standard Deviation 3.3 |
Secondary
PHQ-9 Patient Health Questionnaire (PHQ-9) Depression
Depression was measured with the Patient Health Questionnaire (PHQ-9), which ranged from 0 (no depression) to 27 (severe depression).
Time frame: 24 weeks
Population: We lost 2 patients in arm exercise 1 because we ran out of time limit for the investigation and could not evaluate them and 1 who did not answer our calls . In the NSAIDs arm we recover 3 patients who did not answer the call for three months evaluation, and lost 4 for deadline of the investigation.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Excercise | PHQ-9 Patient Health Questionnaire (PHQ-9) Depression | 2.3 units on a scale | Standard Deviation 2.5 |
| NSAID | PHQ-9 Patient Health Questionnaire (PHQ-9) Depression | 3.1 units on a scale | Standard Deviation 3 |
Secondary
PHQ-9 Patient Health Questionnaire (PHQ-9) Depression
Depression was measured with the Patient Health Questionnaire (PHQ-9), which ranged from 0 (no depression) to 27 (severe depression).
Time frame: At the beginning
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Excercise | PHQ-9 Patient Health Questionnaire (PHQ-9) Depression | 5.7 units on a scale | Standard Deviation 4.3 |
| NSAID | PHQ-9 Patient Health Questionnaire (PHQ-9) Depression | 5.1 units on a scale | Standard Deviation 3 |
Secondary
Quality of Life, Bodily Pain
Improvement in Quality of life was assessed with the SF-36 questionnaire, which ranges from 0 to 100 being 100 the best quality of life. The Short Form (36) Health Survey is a patient-reported survey of patient health. The SF-36 consists of eight scaled scores, which are the weighted sums of the questions in their section. Each scale is directly transformed into a 0-100 scale on the assumption that each question carries equal weight. The lower the score the more disability. The higher the score the less disability i.e. a score of zero is equivalent to maximum disability and a score of 100 is equivalent to no disability. This outcome shows the subdomain data: bodily pain.
Time frame: 24 weeks
Population: We lost 2 patients in arm exercise 1 because we ran out of time limit for the investigation and could not evaluate them and 1 who did not answer our calls . In the NSAIDs arm we recover 3 patients who did not answer the call for three months evaluation, and lost 4 for deadline of the investigation.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Excercise | Quality of Life, Bodily Pain | 74.1 units on a scale | Standard Deviation 22.4 |
| NSAID | Quality of Life, Bodily Pain | 68 units on a scale | Standard Deviation 20.6 |
Secondary
Quality of Life, Bodily Pain
Improvement in Quality of life was assessed with the SF-36 questionnaire, which ranges from 0 to 100 being 100 the best quality of life. The Short Form (36) Health Survey is a patient-reported survey of patient health. The SF-36 consists of eight scaled scores, which are the weighted sums of the questions in their section. Each scale is directly transformed into a 0-100 scale on the assumption that each question carries equal weight. The lower the score the more disability. The higher the score the less disability i.e. a score of zero is equivalent to maximum disability and a score of 100 is equivalent to no disability. This outcome shows the subdomain data: bodily pain.
Time frame: At the beginning
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Excercise | Quality of Life, Bodily Pain | 39.5 units on a scale | Standard Deviation 13.4 |
| NSAID | Quality of Life, Bodily Pain | 39.2 units on a scale | Standard Deviation 13.3 |
Secondary
Quality of Life, Bodily Pain
Improvement in Quality of life was assessed with the SF-36 questionnaire, which ranges from 0 to 100 being 100 the best quality of life. The Short Form (36) Health Survey is a patient-reported survey of patient health. The SF-36 consists of eight scaled scores, which are the weighted sums of the questions in their section. Each scale is directly transformed into a 0-100 scale on the assumption that each question carries equal weight. The lower the score the more disability. The higher the score the less disability i.e. a score of zero is equivalent to maximum disability and a score of 100 is equivalent to no disability. This outcome shows the subdomain data: bodily pain.
Time frame: 4 weeks
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Excercise | Quality of Life, Bodily Pain | 57.8 units on a scale | Standard Deviation 18.7 |
| NSAID | Quality of Life, Bodily Pain | 54.0 units on a scale | Standard Deviation 19.5 |
Secondary
Quality of Life, Bodily Pain
Improvement in Quality of life was assessed with the SF-36 questionnaire, which ranges from 0 to 100 being 100 the best quality of life. The Short Form (36) Health Survey is a patient-reported survey of patient health. The SF-36 consists of eight scaled scores, which are the weighted sums of the questions in their section. Each scale is directly transformed into a 0-100 scale on the assumption that each question carries equal weight. The lower the score the more disability. The higher the score the less disability i.e. a score of zero is equivalent to maximum disability and a score of 100 is equivalent to no disability. This outcome shows the subdomain data: bodily pain.
Time frame: 12 weeks
Population: We lost 4 patients in arm exercise because we ran out of time limit for the investigation and could not evaluate them. And we lost 4 in arm NSAIDs, 3 who did not answer our calls and 1 for close investigation.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Excercise | Quality of Life, Bodily Pain | 67.6 units on a scale | Standard Deviation 21.7 |
| NSAID | Quality of Life, Bodily Pain | 58.7 units on a scale | Standard Deviation 16.1 |
Secondary
Quality of Life, Change in Health
Improvement in Quality of life was assessed with the SF-36 questionnaire, which ranges from 0 to 100 being 100 the best quality of life. The Short Form (36) Health Survey is a patient-reported survey of patient health. The SF-36 consists of eight scaled scores, which are the weighted sums of the questions in their section. Each scale is directly transformed into a 0-100 scale on the assumption that each question carries equal weight. The lower the score the more disability. The higher the score the less disability i.e. a score of zero is equivalent to maximum disability and a score of 100 is equivalent to no disability. This outcome shows the subdomain data: change in health.
Time frame: 24 weeks
Population: We lost 2 patients in arm exercise 1 because we ran out of time limit for the investigation and could not evaluate them and 1 who did not answer our calls . In the NSAIDs arm we recover 3 patients who did not answer the call for three months evaluation, and lost 4 for deadline of the investigation.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Excercise | Quality of Life, Change in Health | 78.0 units on a scale | Standard Deviation 18 |
| NSAID | Quality of Life, Change in Health | 70.7 units on a scale | Standard Deviation 18.2 |
Secondary
Quality of Life, Change in Health
Improvement in Quality of life was assessed with the SF-36 questionnaire, which ranges from 0 to 100 being 100 the best quality of life. The Short Form (36) Health Survey is a patient-reported survey of patient health. The SF-36 consists of eight scaled scores, which are the weighted sums of the questions in their section. Each scale is directly transformed into a 0-100 scale on the assumption that each question carries equal weight. The lower the score the more disability. The higher the score the less disability i.e. a score of zero is equivalent to maximum disability and a score of 100 is equivalent to no disability. This outcome shows the subdomain data: change in health.
Time frame: At the beginning
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Excercise | Quality of Life, Change in Health | 52.6 units on a scale | Standard Deviation 13.5 |
| NSAID | Quality of Life, Change in Health | 54.5 units on a scale | Standard Deviation 16.9 |
Secondary
Quality of Life, Change in Health
Improvement in Quality of life was assessed with the SF-36 questionnaire, which ranges from 0 to 100 being 100 the best quality of life. The Short Form (36) Health Survey is a patient-reported survey of patient health. The SF-36 consists of eight scaled scores, which are the weighted sums of the questions in their section. Each scale is directly transformed into a 0-100 scale on the assumption that each question carries equal weight. The lower the score the more disability. The higher the score the less disability i.e. a score of zero is equivalent to maximum disability and a score of 100 is equivalent to no disability. This outcome shows the subdomain data: change in health.
Time frame: 4 weeks
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Excercise | Quality of Life, Change in Health | 60.4 units on a scale | Standard Deviation 18.1 |
| NSAID | Quality of Life, Change in Health | 61.3 units on a scale | Standard Deviation 21.7 |
Secondary
Quality of Life, Change in Health
Improvement in Quality of life was assessed with the SF-36 questionnaire, which ranges from 0 to 100 being 100 the best quality of life. The Short Form (36) Health Survey is a patient-reported survey of patient health. The SF-36 consists of eight scaled scores, which are the weighted sums of the questions in their section. Each scale is directly transformed into a 0-100 scale on the assumption that each question carries equal weight. The lower the score the more disability. The higher the score the less disability i.e. a score of zero is equivalent to maximum disability and a score of 100 is equivalent to no disability. This outcome shows the subdomain data: change in health.
Time frame: 12 weeks
Population: We lost 4 patients in arm exercise because we ran out of time limit for the investigation and could not evaluate them. And we lost 4 in arm NSAIDs, 3 who did not answer our calls and 1 for close investigation.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Excercise | Quality of Life, Change in Health | 73.3 units on a scale | Standard Deviation 21 |
| NSAID | Quality of Life, Change in Health | 67.0 units on a scale | Standard Deviation 20.5 |
Secondary
Quality of Life, Emotional Performance.
Improvement in Quality of life was assessed with the SF-36 questionnaire, which ranges from 0 to 100 being 100 the best quality of life. The Short Form (36) Health Survey is a patient-reported survey of patient health. The SF-36 consists of eight scaled scores, which are the weighted sums of the questions in their section. Each scale is directly transformed into a 0-100 scale on the assumption that each question carries equal weight. The lower the score the more disability. The higher the score the less disability i.e. a score of zero is equivalent to maximum disability and a score of 100 is equivalent to no disability. This outcome shows the subdomain data: Emotional Performance.
Time frame: 4 weeks
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Excercise | Quality of Life, Emotional Performance. | 82.5 units on a scale | Standard Deviation 32.8 |
| NSAID | Quality of Life, Emotional Performance. | 84.7 units on a scale | Standard Deviation 29.2 |
Secondary
Quality of Life, Emotional Performance.
Improvement in Quality of life was assessed with the SF-36 questionnaire, which ranges from 0 to 100 being 100 the best quality of life. The Short Form (36) Health Survey is a patient-reported survey of patient health. The SF-36 consists of eight scaled scores, which are the weighted sums of the questions in their section. Each scale is directly transformed into a 0-100 scale on the assumption that each question carries equal weight. The lower the score the more disability. The higher the score the less disability i.e. a score of zero is equivalent to maximum disability and a score of 100 is equivalent to no disability. This outcome shows the subdomain data: Emotional Performance.
Time frame: At the beginning
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Excercise | Quality of Life, Emotional Performance. | 67.2 units on a scale | Standard Deviation 36.6 |
| NSAID | Quality of Life, Emotional Performance. | 63.4 units on a scale | Standard Deviation 38.4 |
Secondary
Quality of Life, Emotional Performance.
Improvement in Quality of life was assessed with the SF-36 questionnaire, which ranges from 0 to 100 being 100 the best quality of life. The Short Form (36) Health Survey is a patient-reported survey of patient health. The SF-36 consists of eight scaled scores, which are the weighted sums of the questions in their section. Each scale is directly transformed into a 0-100 scale on the assumption that each question carries equal weight. The lower the score the more disability. The higher the score the less disability i.e. a score of zero is equivalent to maximum disability and a score of 100 is equivalent to no disability. This outcome shows the subdomain data: Emotional Performance.
Time frame: 24 weeks
Population: We lost 2 patients in arm exercise 1 because we ran out of time limit for the investigation and could not evaluate them and 1 who did not answer our calls . In the NSAIDs arm we recover 3 patients who did not answer the call for three months evaluation, and lost 4 for deadline of the investigation.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Excercise | Quality of Life, Emotional Performance. | 94.1 units on a scale | Standard Deviation 21.2 |
| NSAID | Quality of Life, Emotional Performance. | 93.9 units on a scale | Standard Deviation 20.1 |
Secondary
Quality of Life, Emotional Performance.
Improvement in Quality of life was assessed with the SF-36 questionnaire, which ranges from 0 to 100 being 100 the best quality of life. The Short Form (36) Health Survey is a patient-reported survey of patient health. The SF-36 consists of eight scaled scores, which are the weighted sums of the questions in their section. Each scale is directly transformed into a 0-100 scale on the assumption that each question carries equal weight. The lower the score the more disability. The higher the score the less disability i.e. a score of zero is equivalent to maximum disability and a score of 100 is equivalent to no disability. This outcome shows the subdomain data: Emotional Performance.
Time frame: 12 weeks
Population: We lost 4 patients in arm exercise because we ran out of time limit for the investigation and could not evaluate them. And we lost 4 in arm NSAIDs, 3 who did not answer our calls and 1 for close investigation.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Excercise | Quality of Life, Emotional Performance. | 91.2 units on a scale | Standard Deviation 24.5 |
| NSAID | Quality of Life, Emotional Performance. | 82.4 units on a scale | Standard Deviation 33.8 |
Secondary
Quality of Life, General Health Perceptions.
Improvement in Quality of life was assessed with the SF-36 questionnaire, which ranges from 0 to 100 being 100 the best quality of life. The Short Form (36) Health Survey is a patient-reported survey of patient health. The SF-36 consists of eight scaled scores, which are the weighted sums of the questions in their section. Each scale is directly transformed into a 0-100 scale on the assumption that each question carries equal weight. The lower the score the more disability. The higher the score the less disability i.e. a score of zero is equivalent to maximum disability and a score of 100 is equivalent to no disability. This outcome shows the subdomain data: General Health Perceptions.
Time frame: 12 weeks
Population: We lost 4 patients in arm exercise because we ran out of time limit for the investigation and could not evaluate them. And we lost 4 in arm NSAIDs, 3 who did not answer our calls and 1 for close investigation.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Excercise | Quality of Life, General Health Perceptions. | 72.0 units on a scale | Standard Deviation 19.9 |
| NSAID | Quality of Life, General Health Perceptions. | 69.2 units on a scale | Standard Deviation 16.9 |
Secondary
Quality of Life, General Health Perceptions.
Improvement in Quality of life was assessed with the SF-36 questionnaire, which ranges from 0 to 100 being 100 the best quality of life. The Short Form (36) Health Survey is a patient-reported survey of patient health. The SF-36 consists of eight scaled scores, which are the weighted sums of the questions in their section. Each scale is directly transformed into a 0-100 scale on the assumption that each question carries equal weight. The lower the score the more disability. The higher the score the less disability i.e. a score of zero is equivalent to maximum disability and a score of 100 is equivalent to no disability. This outcome shows the subdomain data: General Health Perceptions.
Time frame: At the beginning
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Excercise | Quality of Life, General Health Perceptions. | 64.3 units on a scale | Standard Deviation 19.1 |
| NSAID | Quality of Life, General Health Perceptions. | 64.7 units on a scale | Standard Deviation 18.3 |
Secondary
Quality of Life, General Health Perceptions.
Improvement in Quality of life was assessed with the SF-36 questionnaire, which ranges from 0 to 100 being 100 the best quality of life. The Short Form (36) Health Survey is a patient-reported survey of patient health. The SF-36 consists of eight scaled scores, which are the weighted sums of the questions in their section. Each scale is directly transformed into a 0-100 scale on the assumption that each question carries equal weight. The lower the score the more disability. The higher the score the less disability i.e. a score of zero is equivalent to maximum disability and a score of 100 is equivalent to no disability. This outcome shows the subdomain data: General Health Perceptions.
Time frame: 4 weeks
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Excercise | Quality of Life, General Health Perceptions. | 66.3 units on a scale | Standard Deviation 18.5 |
| NSAID | Quality of Life, General Health Perceptions. | 67.1 units on a scale | Standard Deviation 20.01 |
Secondary
Quality of Life, General Health Perceptions.
Improvement in Quality of life was assessed with the SF-36 questionnaire, which ranges from 0 to 100 being 100 the best quality of life. The Short Form (36) Health Survey is a patient-reported survey of patient health. The SF-36 consists of eight scaled scores, which are the weighted sums of the questions in their section. Each scale is directly transformed into a 0-100 scale on the assumption that each question carries equal weight. The lower the score the more disability. The higher the score the less disability i.e. a score of zero is equivalent to maximum disability and a score of 100 is equivalent to no disability. This outcome shows the subdomain data: General Health Perceptions.
Time frame: 24 weeks
Population: We lost 2 patients in arm exercise 1 because we ran out of time limit for the investigation and could not evaluate them and 1 who did not answer our calls . In the NSAIDs arm we recover 3 patients who did not answer the call for three months evaluation, and lost 4 for deadline of the investigation.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Excercise | Quality of Life, General Health Perceptions. | 73.4 units on a scale | Standard Deviation 17.6 |
| NSAID | Quality of Life, General Health Perceptions. | 69.3 units on a scale | Standard Deviation 15.8 |
Secondary
Quality of Life, Mental Health.
Improvement in Quality of life was assessed with the SF-36 questionnaire, which ranges from 0 to 100 being 100 the best quality of life. The Short Form (36) Health Survey is a patient-reported survey of patient health. The SF-36 consists of eight scaled scores, which are the weighted sums of the questions in their section. Each scale is directly transformed into a 0-100 scale on the assumption that each question carries equal weight. The lower the score the more disability. The higher the score the less disability i.e. a score of zero is equivalent to maximum disability and a score of 100 is equivalent to no disability. This outcome shows the subdomain data: Mental Health.
Time frame: 24 weeks
Population: We lost 2 patients in arm exercise 1 because we ran out of time limit for the investigation and could not evaluate them and 1 who did not answer our calls . In the NSAIDs arm we recover 3 patients who did not answer the call for three months evaluation, and lost 4 for deadline of the investigation.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Excercise | Quality of Life, Mental Health. | 78.5 units on a scale | Standard Deviation 16.1 |
| NSAID | Quality of Life, Mental Health. | 76.9 units on a scale | Standard Deviation 16.3 |
Secondary
Quality of Life, Mental Health.
Improvement in Quality of life was assessed with the SF-36 questionnaire, which ranges from 0 to 100 being 100 the best quality of life. The Short Form (36) Health Survey is a patient-reported survey of patient health. The SF-36 consists of eight scaled scores, which are the weighted sums of the questions in their section. Each scale is directly transformed into a 0-100 scale on the assumption that each question carries equal weight. The lower the score the more disability. The higher the score the less disability i.e. a score of zero is equivalent to maximum disability and a score of 100 is equivalent to no disability. This outcome shows the subdomain data: Mental Health.
Time frame: 12 weeks
Population: We lost 4 patients in arm exercise because we ran out of time limit for the investigation and could not evaluate them. And we lost 4 in arm NSAIDs, 3 who did not answer our calls and 1 for close investigation.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Excercise | Quality of Life, Mental Health. | 76.4 units on a scale | Standard Deviation 16.4 |
| NSAID | Quality of Life, Mental Health. | 75.6 units on a scale | Standard Deviation 16.5 |
Secondary
Quality of Life, Mental Health.
Improvement in Quality of life was assessed with the SF-36 questionnaire, which ranges from 0 to 100 being 100 the best quality of life. The Short Form (36) Health Survey is a patient-reported survey of patient health. The SF-36 consists of eight scaled scores, which are the weighted sums of the questions in their section. Each scale is directly transformed into a 0-100 scale on the assumption that each question carries equal weight. The lower the score the more disability. The higher the score the less disability i.e. a score of zero is equivalent to maximum disability and a score of 100 is equivalent to no disability. This outcome shows the subdomain data: Mental Health.
Time frame: 4 weeks
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Excercise | Quality of Life, Mental Health. | 71.4 units on a scale | Standard Deviation 18.9 |
| NSAID | Quality of Life, Mental Health. | 74.6 units on a scale | Standard Deviation 20 |
Secondary
Quality of Life, Mental Health.
Improvement in Quality of life was assessed with the SF-36 questionnaire, which ranges from 0 to 100 being 100 the best quality of life. The Short Form (36) Health Survey is a patient-reported survey of patient health. The SF-36 consists of eight scaled scores, which are the weighted sums of the questions in their section. Each scale is directly transformed into a 0-100 scale on the assumption that each question carries equal weight. The lower the score the more disability. The higher the score the less disability i.e. a score of zero is equivalent to maximum disability and a score of 100 is equivalent to no disability. This outcome shows the subdomain data: Mental Health.
Time frame: At the beginning
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Excercise | Quality of Life, Mental Health. | 66.4 units on a scale | Standard Deviation 20.6 |
| NSAID | Quality of Life, Mental Health. | 67.0 units on a scale | Standard Deviation 19.8 |
Secondary
Quality of Life, Physical Function.
Improvement in Quality of life was assessed with the SF-36 questionnaire, which ranges from 0 to 100 being 100 the best quality of life. The Short Form (36) Health Survey is a patient-reported survey of patient health. The SF-36 consists of eight scaled scores, which are the weighted sums of the questions in their section. Each scale is directly transformed into a 0-100 scale on the assumption that each question carries equal weight. The lower the score the more disability. The higher the score the less disability i.e. a score of zero is equivalent to maximum disability and a score of 100 is equivalent to no disability. This outcome shows the subdomain data: Physical Function.
Time frame: 24 weeks
Population: We lost 2 patients in arm exercise 1 because we ran out of time limit for the investigation and could not evaluate them and 1 who did not answer our calls . In the NSAIDs arm we recover 3 patients who did not answer the call for three months evaluation, and lost 4 for deadline of the investigation.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Excercise | Quality of Life, Physical Function. | 84.1 units on a scale | Standard Deviation 16.9 |
| NSAID | Quality of Life, Physical Function. | 82.6 units on a scale | Standard Deviation 16 |
Secondary
Quality of Life, Physical Function.
Improvement in Quality of life was assessed with the SF-36 questionnaire, which ranges from 0 to 100 being 100 the best quality of life. The Short Form (36) Health Survey is a patient-reported survey of patient health. The SF-36 consists of eight scaled scores, which are the weighted sums of the questions in their section. Each scale is directly transformed into a 0-100 scale on the assumption that each question carries equal weight. The lower the score the more disability. The higher the score the less disability i.e. a score of zero is equivalent to maximum disability and a score of 100 is equivalent to no disability. This outcome shows the subdomain data: Physical Function.
Time frame: At the beginning
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Excercise | Quality of Life, Physical Function. | 64.6 units on a scale | Standard Deviation 21.6 |
| NSAID | Quality of Life, Physical Function. | 66.5 units on a scale | Standard Deviation 17.8 |
Secondary
Quality of Life, Physical Function.
Improvement in Quality of life was assessed with the SF-36 questionnaire, which ranges from 0 to 100 being 100 the best quality of life. The Short Form (36) Health Survey is a patient-reported survey of patient health. The SF-36 consists of eight scaled scores, which are the weighted sums of the questions in their section. Each scale is directly transformed into a 0-100 scale on the assumption that each question carries equal weight. The lower the score the more disability. The higher the score the less disability i.e. a score of zero is equivalent to maximum disability and a score of 100 is equivalent to no disability. This outcome shows the subdomain data: Physical Function.
Time frame: 4 weeks
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Excercise | Quality of Life, Physical Function. | 75.8 units on a scale | Standard Deviation 17.5 |
| NSAID | Quality of Life, Physical Function. | 70.3 units on a scale | Standard Deviation 23.3 |
Secondary
Quality of Life, Physical Function.
Improvement in Quality of life was assessed with the SF-36 questionnaire, which ranges from 0 to 100 being 100 the best quality of life. The Short Form (36) Health Survey is a patient-reported survey of patient health. The SF-36 consists of eight scaled scores, which are the weighted sums of the questions in their section. Each scale is directly transformed into a 0-100 scale on the assumption that each question carries equal weight. The lower the score the more disability. The higher the score the less disability i.e. a score of zero is equivalent to maximum disability and a score of 100 is equivalent to no disability. This outcome shows the subdomain data: Physical Function.
Time frame: 12 weeks
Population: We lost 4 patients in arm exercise because we ran out of time limit for the investigation and could not evaluate them. And we lost 4 in arm NSAIDs, 3 who did not answer our calls and 1 for close investigation.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Excercise | Quality of Life, Physical Function. | 81.6 units on a scale | Standard Deviation 16 |
| NSAID | Quality of Life, Physical Function. | 77.2 units on a scale | Standard Deviation 82.6 |
Secondary
Quality of Life, Physical Performance.
Improvement in Quality of life was assessed with the SF-36 questionnaire, which ranges from 0 to 100 being 100 the best quality of life. The Short Form (36) Health Survey is a patient-reported survey of patient health. The SF-36 consists of eight scaled scores, which are the weighted sums of the questions in their section. Each scale is directly transformed into a 0-100 scale on the assumption that each question carries equal weight. The lower the score the more disability. The higher the score the less disability i.e. a score of zero is equivalent to maximum disability and a score of 100 is equivalent to no disability. This outcome shows the subdomain data: Physical Performance
Time frame: 12 weeks
Population: We lost 4 patients in arm exercise because we ran out of time limit for the investigation and could not evaluate them. And we lost 4 in arm NSAIDs, 3 who did not answer our calls and 1 for close investigation.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Excercise | Quality of Life, Physical Performance. | 77.3 units on a scale | Standard Deviation 33 |
| NSAID | Quality of Life, Physical Performance. | 72.5 units on a scale | Standard Deviation 40.7 |
Secondary
Quality of Life, Physical Performance.
Improvement in Quality of life was assessed with the SF-36 questionnaire, which ranges from 0 to 100 being 100 the best quality of life. The Short Form (36) Health Survey is a patient-reported survey of patient health. The SF-36 consists of eight scaled scores, which are the weighted sums of the questions in their section. Each scale is directly transformed into a 0-100 scale on the assumption that each question carries equal weight. The lower the score the more disability. The higher the score the less disability i.e. a score of zero is equivalent to maximum disability and a score of 100 is equivalent to no disability. This outcome shows the subdomain data: Physical Performance
Time frame: 4 weeks
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Excercise | Quality of Life, Physical Performance. | 58.1 units on a scale | Standard Deviation 39.4 |
| NSAID | Quality of Life, Physical Performance. | 55.1 units on a scale | Standard Deviation 42.9 |
Secondary
Quality of Life, Physical Performance.
Improvement in Quality of life was assessed with the SF-36 questionnaire, which ranges from 0 to 100 being 100 the best quality of life. The Short Form (36) Health Survey is a patient-reported survey of patient health. The SF-36 consists of eight scaled scores, which are the weighted sums of the questions in their section. Each scale is directly transformed into a 0-100 scale on the assumption that each question carries equal weight. The lower the score the more disability. The higher the score the less disability i.e. a score of zero is equivalent to maximum disability and a score of 100 is equivalent to no disability. This outcome shows the subdomain data: Physical Performance.
Time frame: 24 weeks
Population: We lost 2 patients in arm exercise 1 because we ran out of time limit for the investigation and could not evaluate them and 1 who did not answer our calls . In the NSAIDs arm we recover 3 patients who did not answer the call for three months evaluation, and lost 4 for deadline of the investigation.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Excercise | Quality of Life, Physical Performance. | 84.3 units on a scale | Standard Deviation 33.3 |
| NSAID | Quality of Life, Physical Performance. | 85.2 units on a scale | Standard Deviation 30.7 |
Secondary
Quality of Life, Physical Performance.
Improvement in Quality of life was assessed with the SF-36 questionnaire, which ranges from 0 to 100 being 100 the best quality of life. The Short Form (36) Health Survey is a patient-reported survey of patient health. The SF-36 consists of eight scaled scores, which are the weighted sums of the questions in their section. Each scale is directly transformed into a 0-100 scale on the assumption that each question carries equal weight. The lower the score the more disability. The higher the score the less disability i.e. a score of zero is equivalent to maximum disability and a score of 100 is equivalent to no disability. This outcome shows the subdomain data: Physical Performance
Time frame: At the beginning
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Excercise | Quality of Life, Physical Performance. | 30.5 units on a scale | Standard Deviation 34 |
| NSAID | Quality of Life, Physical Performance. | 36.0 units on a scale | Standard Deviation 40.9 |
Secondary
Quality of Life, Social Function.
Improvement in Quality of life was assessed with the SF-36 questionnaire, which ranges from 0 to 100 being 100 the best quality of life. The Short Form (36) Health Survey is a patient-reported survey of patient health. The SF-36 consists of eight scaled scores, which are the weighted sums of the questions in their section. Each scale is directly transformed into a 0-100 scale on the assumption that each question carries equal weight. The lower the score the more disability. The higher the score the less disability i.e. a score of zero is equivalent to maximum disability and a score of 100 is equivalent to no disability. This outcome shows the subdomain data: Social Function.
Time frame: 12 weeks
Population: We lost 4 patients in arm exercise because we ran out of time limit for the investigation and could not evaluate them. And we lost 4 in arm NSAIDs, 3 who did not answer our calls and 1 for close investigation.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Excercise | Quality of Life, Social Function. | 87.3 units on a scale | Standard Deviation 17.2 |
| NSAID | Quality of Life, Social Function. | 80.4 units on a scale | Standard Deviation 18.3 |
Secondary
Quality of Life, Social Function.
Improvement in Quality of life was assessed with the SF-36 questionnaire, which ranges from 0 to 100 being 100 the best quality of life. The Short Form (36) Health Survey is a patient-reported survey of patient health. The SF-36 consists of eight scaled scores, which are the weighted sums of the questions in their section. Each scale is directly transformed into a 0-100 scale on the assumption that each question carries equal weight. The lower the score the more disability. The higher the score the less disability i.e. a score of zero is equivalent to maximum disability and a score of 100 is equivalent to no disability. This outcome shows the subdomain data: Social Function.
Time frame: 24 weeks
Population: We lost 2 patients in arm exercise 1 because we ran out of time limit for the investigation and could not evaluate them and 1 who did not answer our calls . In the NSAIDs arm we recover 3 patients who did not answer the call for three months evaluation, and lost 4 for deadline of the investigation.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Excercise | Quality of Life, Social Function. | 88.6 units on a scale | Standard Deviation 17.4 |
| NSAID | Quality of Life, Social Function. | 86 units on a scale | Standard Deviation 15.1 |
Secondary
Quality of Life, Social Function.
Improvement in Quality of life was assessed with the SF-36 questionnaire, which ranges from 0 to 100 being 100 the best quality of life. The Short Form (36) Health Survey is a patient-reported survey of patient health. The SF-36 consists of eight scaled scores, which are the weighted sums of the questions in their section. Each scale is directly transformed into a 0-100 scale on the assumption that each question carries equal weight. The lower the score the more disability. The higher the score the less disability i.e. a score of zero is equivalent to maximum disability and a score of 100 is equivalent to no disability. This outcome shows the subdomain data: Social Function.
Time frame: 4 weeks
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Excercise | Quality of Life, Social Function. | 80.7 units on a scale | Standard Deviation 19.9 |
| NSAID | Quality of Life, Social Function. | 74.8 units on a scale | Standard Deviation 24.4 |
Secondary
Quality of Life, Social Function.
Improvement in Quality of life was assessed with the SF-36 questionnaire, which ranges from 0 to 100 being 100 the best quality of life. The Short Form (36) Health Survey is a patient-reported survey of patient health. The SF-36 consists of eight scaled scores, which are the weighted sums of the questions in their section. Each scale is directly transformed into a 0-100 scale on the assumption that each question carries equal weight. The lower the score the more disability. The higher the score the less disability i.e. a score of zero is equivalent to maximum disability and a score of 100 is equivalent to no disability. This outcome shows the subdomain data: Social Function.
Time frame: At the beginning
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Excercise | Quality of Life, Social Function. | 71.3 units on a scale | Standard Deviation 23.5 |
| NSAID | Quality of Life, Social Function. | 65.9 units on a scale | Standard Deviation 24.2 |
Secondary
Quality of Life, Vitality.
Improvement in Quality of life was assessed with the SF-36 questionnaire, which ranges from 0 to 100 being 100 the best quality of life. The Short Form (36) Health Survey is a patient-reported survey of patient health. The SF-36 consists of eight scaled scores, which are the weighted sums of the questions in their section. Each scale is directly transformed into a 0-100 scale on the assumption that each question carries equal weight. The lower the score the more disability. The higher the score the less disability i.e. a score of zero is equivalent to maximum disability and a score of 100 is equivalent to no disability. This outcome shows the subdomain data: Vitality.
Time frame: 12 weeks
Population: We lost 4 patients in arm exercise because we ran out of time limit for the investigation and could not evaluate them. And we lost 4 in arm NSAIDs, 3 who did not answer our calls and 1 for close investigation.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Excercise | Quality of Life, Vitality. | 67.5 units on a scale | Standard Deviation 17.7 |
| NSAID | Quality of Life, Vitality. | 66.6 units on a scale | Standard Deviation 15.6 |
Secondary
Quality of Life, Vitality.
Improvement in Quality of life was assessed with the SF-36 questionnaire, which ranges from 0 to 100 being 100 the best quality of life. The Short Form (36) Health Survey is a patient-reported survey of patient health. The SF-36 consists of eight scaled scores, which are the weighted sums of the questions in their section. Each scale is directly transformed into a 0-100 scale on the assumption that each question carries equal weight. The lower the score the more disability. The higher the score the less disability i.e. a score of zero is equivalent to maximum disability and a score of 100 is equivalent to no disability. This outcome shows the subdomain data: Vitality.
Time frame: At the beginning
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Excercise | Quality of Life, Vitality. | 55.5 units on a scale | Standard Deviation 17.9 |
| NSAID | Quality of Life, Vitality. | 55.3 units on a scale | Standard Deviation 17.6 |
Secondary
Quality of Life, Vitality.
Improvement in Quality of life was assessed with the SF-36 questionnaire, which ranges from 0 to 100 being 100 the best quality of life. The Short Form (36) Health Survey is a patient-reported survey of patient health. The SF-36 consists of eight scaled scores, which are the weighted sums of the questions in their section. Each scale is directly transformed into a 0-100 scale on the assumption that each question carries equal weight. The lower the score the more disability. The higher the score the less disability i.e. a score of zero is equivalent to maximum disability and a score of 100 is equivalent to no disability. This outcome shows the subdomain data: Vitality.
Time frame: 4 weeks
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Excercise | Quality of Life, Vitality. | 61.3 units on a scale | Standard Deviation 18.5 |
| NSAID | Quality of Life, Vitality. | 64.0 units on a scale | Standard Deviation 20.2 |
Secondary
Quality of Life, Vitality.
Improvement in Quality of life was assessed with the SF-36 questionnaire, which ranges from 0 to 100 being 100 the best quality of life. The Short Form (36) Health Survey is a patient-reported survey of patient health. The SF-36 consists of eight scaled scores, which are the weighted sums of the questions in their section. Each scale is directly transformed into a 0-100 scale on the assumption that each question carries equal weight. The lower the score the more disability. The higher the score the less disability i.e. a score of zero is equivalent to maximum disability and a score of 100 is equivalent to no disability. This outcome shows the subdomain data: Vitality.
Time frame: 24 weeks
Population: We lost 2 patients in arm exercise 1 because we ran out of time limit for the investigation and could not evaluate them and 1 who did not answer our calls . In the NSAIDs arm we recover 3 patients who did not answer the call for three months evaluation, and lost 4 for deadline of the investigation.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Excercise | Quality of Life, Vitality. | 70.3 units on a scale | Standard Deviation 17 |
| NSAID | Quality of Life, Vitality. | 62.8 units on a scale | Standard Deviation 14.5 |
Secondary
Relapses of Lumbar Pain
The percentage of patients with relapsed of low back pain was measured.
Time frame: 12 weeks
Population: We lost 4 patients in arm exercise because we ran out of time limit for the investigation and could not evaluate them. And we lost 4 in arm NSAIDs, 3 who did not answer our calls and 1 for close investigation.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Excercise | Relapses of Lumbar Pain | 7.1 percentage of participants |
| NSAID | Relapses of Lumbar Pain | 25 percentage of participants |
Secondary
Relapses of Lumbar Pain
The percentage of patients with relapsed of low back pain was measured.
Time frame: 24 weeks
Population: We lost 2 patients in arm exercise 1 because we ran out of time limit for the investigation and could not evaluate them and 1 who did not answer our calls . In the NSAIDs arm we recover 3 patients who did not answer the call for three months evaluation, and lost 4 for deadline of the investigation.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Excercise | Relapses of Lumbar Pain | 5.0 percentage of participants |
| NSAID | Relapses of Lumbar Pain | 20.5 percentage of participants |
Secondary
Roland-Morris Questionnaire
Improvement in function assessed by the Roland-Morris questionnaire, a widely used health status measure for low back pain. The RMDQ can be used in research or clinical practice. Scoring the RMDQ. The RMDQ is scored by adding up the number of items checked by the patient. The score can therefore vary from 0 to 24. It is not recommended to give patients a 'Yes' / 'No' option. If patients indicate in any way that an item is not applicable to them, the item is scored 'No', i.e. the denominator remains 24. Being worst 24.
Time frame: 24 weeks
Population: We lost 2 patients in arm exercise 1 because we ran out of time limit for the investigation and could not evaluate them and 1 who did not answer our calls . In the NSAIDs arm we recover 3 patients who did not answer the call for three months evaluation, and lost 4 for deadline of the investigation.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Excercise | Roland-Morris Questionnaire | 2.3 units on a scale | Standard Deviation 3 |
| NSAID | Roland-Morris Questionnaire | 2.5 units on a scale | Standard Deviation 2.6 |
Secondary
Roland-Morris Questionnaire
Improvement in function assessed by the Roland-Morris questionnaire, a widely used health status measure for low back pain. The RMDQ can be used in research or clinical practice. Scoring the RMDQ. The RMDQ is scored by adding up the number of items checked by the patient. The score can therefore vary from 0 to 24. It is not recommended to give patients a 'Yes' / 'No' option. If patients indicate in any way that an item is not applicable to them, the item is scored 'No', i.e. the denominator remains 24. Being worst 24.
Time frame: 12 weeks
Population: We lost 4 patients in arm exercise because we ran out of time limit for the investigation and could not evaluate them. And we lost 4 in arm NSAIDs, 3 who did not answer our calls and 1 for close investigation.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Excercise | Roland-Morris Questionnaire | 2.6 units on a scale | Standard Deviation 2.5 |
| NSAID | Roland-Morris Questionnaire | 3.2 units on a scale | Standard Deviation 2.4 |
Secondary
Roland-Morris Questionnaire
Improvement in function assessed by the Roland-Morris questionnaire, a widely used health status measure for low back pain. The RMDQ can be used in research or clinical practice. Scoring the RMDQ. The RMDQ is scored by adding up the number of items checked by the patient. The score can therefore vary from 0 to 24. It is not recommended to give patients a 'Yes' / 'No' option. If patients indicate in any way that an item is not applicable to them, the item is scored 'No', i.e. the denominator remains 24. Being worst 24.
Time frame: 4 weeks
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Excercise | Roland-Morris Questionnaire | 4.2 units on a scale | Standard Deviation 3.2 |
| NSAID | Roland-Morris Questionnaire | 4.6 units on a scale | Standard Deviation 4 |
Secondary
Roland-Morris Questionnaire
Improvement in function assessed by the Roland-Morris questionnaire, a widely used health status measure for low back pain. The RMDQ can be used in research or clinical practice. Scoring the RMDQ. The RMDQ is scored by adding up the number of items checked by the patient. The score can therefore vary from 0 to 24. It is not recommended to give patients a 'Yes' / 'No' option. If patients indicate in any way that an item is not applicable to them, the item is scored 'No', i.e. the denominator remains 24. Being worst 24.
Time frame: At the beginning
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Excercise | Roland-Morris Questionnaire | 6.9 units on a scale | Standard Deviation 4.4 |
| NSAID | Roland-Morris Questionnaire | 7.7 units on a scale | Standard Deviation 5.2 |
Secondary
Treatments Associated With Low Back Pain at 6 Months
we are showing in this result, the number of patients who had to receive any additional treatment in either group. The measure is the number of participants who received additional treatment throughout the duration of the study.
Time frame: 6 months
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Excercise | Treatments Associated With Low Back Pain at 6 Months | 3 participants |
| NSAID | Treatments Associated With Low Back Pain at 6 Months | 14 participants |