Low Back Pain
Conditions
Brief summary
This is a randomized clinical trial comparing two interventions for acute low back pain: 1. Ibuprofen + acetaminophen 2. Ibuprofen + placebo Participants will include patients who present to an emergency room for management of low back pain. Medication will be dispensed to participants at the time of emergency room discharge. Data will be collected from participants by telephone for 1 week.
Interventions
DRUGAcetaminophen
Acetaminophen 500-1000mg every 6 hours
DRUGIbuprofen 600 mg
Ibuprofen 600mg every 6 hours
BEHAVIORALEducational intervention
Research personnel will provide each patient with a 15-minute educational intervention. This will be based on NIAMS (National Institute of Arthritis and Musculoskeletal and Skin Diseases) Handout on Health: Back Pain information webpage (available at http://www.niams.nih.gov/Health\_Info/Back\_Pain/default.asp)
DRUGPlacebo oral capsule
To match acetaminophen, patients will take one or two capsules every 6 hours
Sponsors
Montefiore Medical Center
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to 69 Years
Healthy volunteers
No
Inclusion criteria
Present to emergency room primary for management of LBP, defined as pain originating between the lower border of the scapulae and the upper gluteal folds. Flank pain, that is pain originating from tissues lateral to the paraspinal muscles, will not be included. * Musculoskeletal etiology of low back. Patients with non-musculoskeletal etiologies such as urinary tract infection, ovarian cysts, or influenza like illness will be excluded. The primary clinical diagnosis, at the conclusion of the emergency room visit, must be a diagnosis consistent with non-traumatic, non-radicular, musculoskeletal low back pain. * Patient is to be discharged home. * Age 18-69 * Non-radicular pain. Patients will be excluded if the pain radiates below the gluteal folds in a radicular pattern. * Pain duration \<2 weeks (336 hours). * Prior to the acute attack of LBP, back pain cannot occur more frequently than once per month. * Non-traumatic LBP: no substantial and direct trauma to the back within the previous month * Functionally impairing back pain: A baseline score of \> 5 on the Roland-Morris Disability Questionnaire
Exclusion criteria
* Not available for follow-up * Pregnant * Chronic pain syndrome defined as use of any analgesic medication on a daily or near-daily basis * Allergic to or intolerant of investigational medications
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change in Functional Impairment as Measured by the Roland Morris Disability Questionnaire | Baseline and one week after discharge from emergency department | The Roland Morris Disability Questionnaire (RMDQ) is a 24 item instrument that evaluates the impact of low back pain on one's daily life. It is most sensitive for patients with mild to moderate disability due to acute, sub-acute or chronic low back pain. Each question can be answered as either a yes or no. The score ranges from 0 to 24 where a higher score reflects greater impairment and, therefore, worsening in the quality of life. The change in RMDQ is obtained by subtracting the RMDQ score at one week after discharge from the baseline score. The calculated mean and associated confidence interval values have been verified by staff statisticians. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Number of Participants With Moderate or Severe Pain, as Measured on an Ordinal Scale | 7 days after discharge from emergency department | Data collected by telephone questionnaire. Participants asked to assess intensity of low back pain over the previous 24 hours, using a four point ordinal scale: severe, moderate, mild, or none. |
| Number of Participants Who Required Analgesic Medication for Low Back Pain Within the Previous 24 Hours. | 7 days after discharge from emergency department | Telephone questionnaire is used to assess number of patients needing any analgesic or low back pain medication within the previous 24 hours. |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Ibuprofen and Acetaminophen Acetaminophen 500-1000mg every 6 hours for 7 days Participants in this arm will also receive ibuprofen 600mg every 6 hours for 7 days and an educational intervention.
Acetaminophen: Acetaminophen 500-1000mg every 6 hours
Ibuprofen 600 mg: Ibuprofen 600mg every 6 hours
Educational intervention: Research personnel will provide each patient with a 15-minute educational intervention. This will be based on NIAMS (National Institute of Arthritis and Musculoskeletal and Skin Diseases) Handout on Health: Back Pain information webpage (available at http://www.niams.nih.gov/Health\_Info/Back\_Pain/default.asp) | 60 |
| Ibuprofen and Placebo Placebo Participants in this arm will also receive ibuprofen 600mg every 6 hours for 7 days and an educational intervention.
Ibuprofen 600 mg: Ibuprofen 600mg every 6 hours
Educational intervention: Research personnel will provide each patient with a 15-minute educational intervention. This will be based on NIAMS (National Institute of Arthritis and Musculoskeletal and Skin Diseases) Handout on Health: Back Pain information webpage (available at http://www.niams.nih.gov/Health\_Info/Back\_Pain/default.asp)
Placebo oral capsule: To match acetaminophen, patients will take one or two capsules every 6 hours | 60 |
| Total | 120 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Overall Study | Lost to Follow-up | 3 | 7 |
Baseline characteristics
| Characteristic | Ibuprofen and Acetaminophen | Ibuprofen and Placebo | Total |
|---|---|---|---|
| Age, Continuous | 41 years STANDARD_DEVIATION 12 | 41 years STANDARD_DEVIATION 13 | 41 years STANDARD_DEVIATION 12 |
| Duration of low back pain | 48 hours | 48 hours | 48 hours |
| Race and Ethnicity Not Collected | — | — | 0 Participants |
| Region of Enrollment United States | 60 participants | 60 participants | 120 participants |
| Sex: Female, Male Female | 29 Participants | 28 Participants | 57 Participants |
| Sex: Female, Male Male | 31 Participants | 32 Participants | 63 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 60 | 0 / 60 |
| other Total, other adverse events | 5 / 60 | 2 / 60 |
| serious Total, serious adverse events | 0 / 60 | 0 / 60 |
Outcome results
Primary
Change in Functional Impairment as Measured by the Roland Morris Disability Questionnaire
The Roland Morris Disability Questionnaire (RMDQ) is a 24 item instrument that evaluates the impact of low back pain on one's daily life. It is most sensitive for patients with mild to moderate disability due to acute, sub-acute or chronic low back pain. Each question can be answered as either a yes or no. The score ranges from 0 to 24 where a higher score reflects greater impairment and, therefore, worsening in the quality of life. The change in RMDQ is obtained by subtracting the RMDQ score at one week after discharge from the baseline score. The calculated mean and associated confidence interval values have been verified by staff statisticians.
Time frame: Baseline and one week after discharge from emergency department
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Ibuprofen and Acetaminophen | Change in Functional Impairment as Measured by the Roland Morris Disability Questionnaire | 11.1 units on a scale | Standard Deviation 10.7 |
| Ibuprofen and Placebo | Change in Functional Impairment as Measured by the Roland Morris Disability Questionnaire | 11.9 units on a scale | Standard Deviation 9.7 |
Secondary
Number of Participants Who Required Analgesic Medication for Low Back Pain Within the Previous 24 Hours.
Telephone questionnaire is used to assess number of patients needing any analgesic or low back pain medication within the previous 24 hours.
Time frame: 7 days after discharge from emergency department
Population: Data was collected and analyzed for 52 participants in the Ibuprofen and Placebo group.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Ibuprofen and Acetaminophen | Number of Participants Who Required Analgesic Medication for Low Back Pain Within the Previous 24 Hours. | 36 Participants |
| Ibuprofen and Placebo | Number of Participants Who Required Analgesic Medication for Low Back Pain Within the Previous 24 Hours. | 32 Participants |
Secondary
Number of Participants With Moderate or Severe Pain, as Measured on an Ordinal Scale
Data collected by telephone questionnaire. Participants asked to assess intensity of low back pain over the previous 24 hours, using a four point ordinal scale: severe, moderate, mild, or none.
Time frame: 7 days after discharge from emergency department
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Ibuprofen and Acetaminophen | Number of Participants With Moderate or Severe Pain, as Measured on an Ordinal Scale | 16 Participants |
| Ibuprofen and Placebo | Number of Participants With Moderate or Severe Pain, as Measured on an Ordinal Scale | 15 Participants |