Low Back Pain
Conditions
Keywords
Exercise Therapy, Clinical Trial, Diathermy, Physical Therapy Modalities
Brief summary
The aim of this study is to verify the effectiveness of the association of Shortwave Diathermy and Pilates exercises in patients with chronic non-specific low back pain, on the reduction of pain, functional disability and improvement of the quality of life.
Detailed description
The drawing of the study will be a prospective, randomized controlled trial and double-blind with quantitative approach. Study participants 36 subjects diagnosed with non-specific chronic low back pain, which will be divided in two groups with 18 subjects in each: experimental group, which will be submitted to placebo + exercise shortwave diathermy and the control group to do active + exercise shortwave diathermy. There will be 12 one-hour sessions twice a week. The subjects will apply Shortwave Diathermy for 20 minutes, followed by Pilates mat.
Interventions
DEVICEPilates and Shortwave placebo
Pilates exercises and application of the device without produce thermal effects
DEVICEPilates and Shortwave active
Pilates exercises and application of the device producing thermal effects
Sponsors
University of Sao Paulo General Hospital
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to 80 Years
Healthy volunteers
No
Inclusion criteria
* individuals diagnosed with chronic non-specific low back pain for a period of more than 3 months, without irradiation for lower limbs; * who present pain intensity greater than 3 points in the Numerical Pain Scale; * to sign the Free and Informed Consent Form.
Exclusion criteria
* BMI\> 30; * previous surgeries in the spine; * severe spinal affection (tumors, infection, unconsolidated or vicious consolidation fractures, inflammatory diseases); * rheumatic disease; * contraindication to performing the exercises according to the American College of Sports Medicine Guidelines; * degenerative or inflammatory joint and other body segments; * patients who are in labor litigation; * pregnancy; * patients who are undergoing other type of physiotherapeutic or drug treatment.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change in pain through Pain visual analogue scale | Before the treatment, up to 3, 6 and 18 weeks | Scale with 11 centimeters is used for evaluate pain intensity, being 0 no pain and 10 the worst possible pain |
| Change in pain through The McGill pain questionnaire | Before the treatment, up to 3, 6 and 18 weeks | It is organized in four categories: sensory, affective, evaluative and mixed, with 20 subcategories and 78 words descriptors of pain, describing the quality of pain. The pain evaluation index is the sum of the values added, and each word chosen in each dimension is the maximum score of each category: Sensory = 34, Affective = 17, Evaluative = 5, Mixed = 11, Total = 67. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Perception of global effect | Before the treatment, up to 3, 6 and 18 weeks | Evaluates the level of perception of patient recovery through a Scale Numbers of 11 points comparing the onset of symptoms at the beginning of treatment in relation to the last days. It varies from -5 to +5, being -5: extremely worse; zero: no modification; and +5: fully recovered, with the highest score representing greater recovery. |
| Emotional Functioning | Before the treatment, up to 3, 6 and 18 weeks | It will be evaluated by the Brazilian version of the Visual Analog Scale for anxiety. Analogic visual scale for anxiety is a horizontal line of 100 mm in length. The tip left without anxiety and the right tip means worse anxiety. |
| Functional disability | Before the treatment, up to 3, 6 and 18 weeks | The Rolland and Morris Questionnaire, validated in Brazil, will quantify the functional limitations caused by low back pain. The questionnaire is composed of 24 questions related to normal activities of daily living, in which each affirmative answer corresponds to a point. The final score is determined by the sum of the values obtained. Values close to zero represent the best results (lower limitation), and values close to 24 the worst results. Values above 14 points are considered as a severe spinal impairment. |
| Symptoms and adverse events | Before the treatment, up to 3, 6 and 18 weeks | The record of the symptoms and adverse events that occurred during the established behavior will be captured passively through spontaneous reports of the patient. The active catch will use a questionnaire with a record of the duration and intensity of the adverse symptom reported by the patient. You will then be asked to the patient graduates the certainty of their affirmations according to a Likert scale (being 1 not certain and 5 total certainty). |
| Patient Satisfaction: The MedRisk scale | Patients will be evaluated up to 6 weeks | The MedRisk scale consists of 20 items, 10 items related to the therapist-patient interaction; 8 items involving evaluation of the infrastructure and work organization of the physical therapy clinic and 2 items that are considered as global evaluation of the treatment. The patient elects level of satisfaction in each item by selecting a Likert scale ranging from 1 completely disagree to 5 agree completely or through an option not applicable, with high scores representing high satisfaction. |
| Depressive Symptom | Before the treatment, up to 3, 6 and 18 weeks | It will be evaluated by the Brazilian version of the Beck Depression Inventory, a self-assessment measure of depression. It is a questionnaire with 21 items whose intensity ranges from 0 to 3 points. Largest scores indicate more depressive symptoms. |
| Patients' perceptions of their health-related quality of life: The Short-Form Health Survey questionnaire (SF-36) | Before the treatment, up to 3, 6 and 18 weeks | The Short-Form Health Survey questionnaire (SF-36) will assess the health-related quality of life of patients. This instrument contains 36 questions grouped into eight areas: functional capacity (10 items), physical aspects (2 items), pain (2 items), general state of health (5 items), vitality (4 items), social aspects (2 items), emotional (3 items) and mental health (5 items). The values in each domain vary from 0 to 100 and, more indicate a better quality of life. |
Countries
Brazil
Outcome results
None listed