Low Back Pain
Conditions
Brief summary
This is a randomized, double-blind placebo-controlled study comparing two different treatments for acute low back pain: oral ibuprofen and topical diclofenac. Participants will be randomized to one of three study arms: 1) Oral ibuprofen + topical diclofenac; 2) Oral ibuprofen + topical placebo; 3) Oral placebo + topical diclofenac. Outcomes will be determined at 48 hours (2 days) and 7 days later.
Interventions
DRUGIbuprofen 400 mg
Ibuprofen 400mg
Diclofenac 1% gel 4gm
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 Department (ED) primary for management of Low Back Pain (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 ED visit, must be a diagnosis consistent with non-traumatic, non-radicular, musculoskeletal LBP. * Patient is to be discharged home. * Age 18-69. Enrollment will be limited to adults younger than 70 years because of the increased risk of adverse medication effects in the elderly. * 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 must occur less 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 * Any analgesic medication use on a daily or near-daily basis * Allergic to or intolerant of investigational medications * Open wounds or skin breakdown of the lower back * Contra-indications to investigational medications: 1) known peptic ulcer disease, chronic dyspepsia, or history of gastrointestinal bleed 2) Severe heart failure (NYHA 2 or worse) 3) Chronic kidney disease (GFR \<60ml/min) 4) Current use of anti-coagulants 5) cirrhosis (Child Pugh A or worse) or hepatitis (transaminases 2x the upper limit of normal)
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change in Pain Disability - Roland Morris Disability Questionnaire (RMDQ) Score | Baseline to 48 hours | Change in Pain Disability was assessed using the Roland-Morris Disability Questionnaire (RMDQ). The RMDQ is a 24-item self-report 'Yes/no' instrument about how low-back pain affects functional activities. Each question is worth one point so scores can range from 0 (no disability) to 24 (severe disability). Change in RMDQ was measured by calculating: 'Baseline RMDQ score - RMDQ Score at 2-day (48 hour) follow-up' with positive scores being indicative of improvement (less pain disability). |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Worst Low Back Pain (LBP) | 48 hours | Worst low back was evaluated by asking patients "How would you describe your worst low back pain in the last 24 hours?" Patients were asked to describe their worst LBP using the terms "Severe", "Moderate", "Mild", or "None". Counts of participants reporting each degree of severity over the prior 24 hours are summarized. |
| Use of Medication for Low Back Pain (LBP) | 48 hours | Participants were asked "During the last 24 hours, have you taken any medication at all for low back pain?" and asked to respond either "Yes" or "No". Counts of participants using medication during the prior 24 hours are summarized. |
| Frequency of Low Back Pain (LBP) | 48 hours | Frequency of Low Back Pain will be evaluated by asking patients "Over the last 24 hours, how often were you in pain?" Patients will be asked to respond to the frequency of their LBP over the prior 24 hours based on a 5-point Likert scale consisting of "Not at all", "Rarely", "Sometimes", "Usually", or "Always". This question will help determine the burdensomeness of the LBP in the patient's daily life. Counts of participants reporting each frequency will be summarized. |
| Return to Usual Activities | 48 hours | The percentage of patients who were able to return to usual activities following treatment will be quantified by asking patients to provide a binary "Yes" or "No" response to a question of whether they were able to return to day-to-day activities. Results will be summarized by treatment group. |
| Number of Visits to Any Healthcare Provider | 48 hours | The number of visits to any healthcare provider will be determined by asking patients whether they had any planned or emergent inpatient or outpatient visits to any healthcare provider for any reason during the course of the study. Group mean results will be summarized by treatment group. |
| Treatment Satisfaction | 48 hours | Patient satisfaction with the treatment they received will be assessed by their response to a binary "Yes" or "No" question regarding satisfaction with their treatment. Results will be summarized by treatment group. |
| Change in Pain Disability - Roland Morris Disability Questionnaire (RMDQ) Score | 7 days | Change in Pain Disability was assessed using the Roland-Morris Disability Questionnaire (RMDQ). The RMDQ is a 24-item self-report questionnaire about how low-back pain affects functional activities. Each question is worth one point so scores can range from 0 (no disability) to 24 (severe disability). Change in RMDQ was measured by calculating: 'Baseline RMDQ score - RMDQ Score at 7-day follow-up with positive scores being indicative of improvement (less pain disability). |
| Frequency of Low Back Pain | 7 days | Frequency of Low Back Pain will be evaluated by asking patients "Over the last 24 hours, how often were you in pain?" Patients will be asked to respond to the frequency of their LBP over the prior 24 hours based on a 5-point Likert scale consisting of "Not at all", "Rarely", "Sometimes", "Usually", or "Always". This question will help determine the burdensomeness of the LBP in the patient's daily life. Counts of participants reporting each frequency will be summarized. |
Countries
United States
Contacts
PRINCIPAL_INVESTIGATORBenjamin Friedman, MD
Montefiore Medical Center
Participant flow
Recruitment details
Enrollment commenced in March 2021 and concluded in June 2023. The study was conducted in 2 Emergency Departments (EDs) both affiliated with Montefiore Medical Center.
Pre-assignment details
In total, 3281 patients were screened for participation and 198 were randomized into the study. 1 patient was excluded post-randomization due to missing RMDQ data.
Participants by arm
| Arm | Count |
|---|---|
| Oral Ibuprofen + Topical Diclofenac Oral ibuprofen 400mg Topical diclofenac 4gm
Ibuprofen 400 mg: Ibuprofen 400mg
Topical diclofenac: Diclofenac 1% gel 4gm | 65 |
| Oral Ibuprofen + Topical Placebo Oral ibuprofen 400mg Topical placebo
Ibuprofen 400 mg: Ibuprofen 400mg | 66 |
| Oral Placebo + Topical Diclofenac Oral placebo Topical diclofenac 4gm
Topical diclofenac: Diclofenac 1% gel 4gm | 66 |
| Total | 197 |
Baseline characteristics
| Characteristic | Oral Ibuprofen + Topical Diclofenac | Total | Oral Placebo + Topical Diclofenac | Oral Ibuprofen + Topical Placebo |
|---|---|---|---|---|
| Age, Continuous | 39 years STANDARD_DEVIATION 13 | 38 years STANDARD_DEVIATION 13 | 39 years STANDARD_DEVIATION 13 | 37 years STANDARD_DEVIATION 13 |
| Duration of Low Back Pain before presentation to ED | 72 hours | 56 hours | 48 hours | 48 hours |
| Patients with Previous Episodes of Low Back Pain Few Times Before | 36 Participants | 102 Participants | 37 Participants | 29 Participants |
| Patients with Previous Episodes of Low Back Pain Never Before | 15 Participants | 57 Participants | 18 Participants | 24 Participants |
| Patients with Previous Episodes of Low Back Pain Once a Month | 0 Participants | 3 Participants | 2 Participants | 1 Participants |
| Patients with Previous Episodes of Low Back Pain Once a Year | 14 Participants | 35 Participants | 9 Participants | 12 Participants |
| Race/Ethnicity, Customized Asian | 0 Participants | 2 Participants | 2 Participants | 0 Participants |
| Race/Ethnicity, Customized Black/African-American | 9 Participants | 44 Participants | 19 Participants | 16 Participants |
| Race/Ethnicity, Customized Hispanic/Latino | 51 Participants | 136 Participants | 42 Participants | 43 Participants |
| Race/Ethnicity, Customized Multiracial | 0 Participants | 1 Participants | 0 Participants | 1 Participants |
| Race/Ethnicity, Customized Other | 1 Participants | 2 Participants | 0 Participants | 1 Participants |
| Race/Ethnicity, Customized Refused | 1 Participants | 6 Participants | 2 Participants | 3 Participants |
| Race/Ethnicity, Customized White | 3 Participants | 6 Participants | 1 Participants | 2 Participants |
| Region of Enrollment United States | 65 participants | 197 participants | 66 participants | 66 participants |
| Roland-Morris Disability Questionnaire (RMDQ) at ED visit | 19 score on a scale | 18 score on a scale | 17 score on a scale | 19 score on a scale |
| Sex: Female, Male Female | 20 Participants | 72 Participants | 18 Participants | 34 Participants |
| Sex: Female, Male Male | 45 Participants | 125 Participants | 48 Participants | 32 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk |
|---|---|---|---|
| deaths Total, all-cause mortality | 0 / 60 | 0 / 60 | 0 / 63 |
| other Total, other adverse events | 4 / 60 | 3 / 60 | 1 / 63 |
| serious Total, serious adverse events | 0 / 60 | 0 / 60 | 0 / 63 |
Outcome results
Primary
Change in Pain Disability - Roland Morris Disability Questionnaire (RMDQ) Score
Change in Pain Disability was assessed using the Roland-Morris Disability Questionnaire (RMDQ). The RMDQ is a 24-item self-report 'Yes/no' instrument about how low-back pain affects functional activities. Each question is worth one point so scores can range from 0 (no disability) to 24 (severe disability). Change in RMDQ was measured by calculating: 'Baseline RMDQ score - RMDQ Score at 2-day (48 hour) follow-up' with positive scores being indicative of improvement (less pain disability).
Time frame: Baseline to 48 hours
Population: 5 participants in the 'Oral ibuprofen + topical diclofenac' group; 6 participants in the 'Oral ibuprofen + topical placebo' group; and 3 participants in the 'Oral placebo + topical diclofenac' group were lost to follow-up (LTFU) prior to the 48 hour assessment timepoints.
| Arm | Measure | Value (MEAN) |
|---|---|---|
| Oral Ibuprofen + Topical Diclofenac | Change in Pain Disability - Roland Morris Disability Questionnaire (RMDQ) Score | 8.7 score on a scale |
| Oral Ibuprofen + Topical Placebo | Change in Pain Disability - Roland Morris Disability Questionnaire (RMDQ) Score | 10.1 score on a scale |
| Oral Placebo + Topical Diclofenac | Change in Pain Disability - Roland Morris Disability Questionnaire (RMDQ) Score | 6.4 score on a scale |
Secondary
Change in Pain Disability - Roland Morris Disability Questionnaire (RMDQ) Score
Change in Pain Disability was assessed using the Roland-Morris Disability Questionnaire (RMDQ). The RMDQ is a 24-item self-report questionnaire about how low-back pain affects functional activities. Each question is worth one point so scores can range from 0 (no disability) to 24 (severe disability). Change in RMDQ was measured by calculating: 'Baseline RMDQ score - RMDQ Score at 7-day follow-up with positive scores being indicative of improvement (less pain disability).
Time frame: 7 days
Population: 5 participants in the 'Oral ibuprofen + topical diclofenac' group; 6 participants in the 'Oral ibuprofen + topical placebo' group; and 3 participants in the 'Oral placebo + topical diclofenac' group were lost to follow-up prior to the 7-day assessment timepoints.
| Arm | Measure | Value (MEAN) |
|---|---|---|
| Oral Ibuprofen + Topical Diclofenac | Change in Pain Disability - Roland Morris Disability Questionnaire (RMDQ) Score | 10.7 score on a scale |
| Oral Ibuprofen + Topical Placebo | Change in Pain Disability - Roland Morris Disability Questionnaire (RMDQ) Score | 12.2 score on a scale |
| Oral Placebo + Topical Diclofenac | Change in Pain Disability - Roland Morris Disability Questionnaire (RMDQ) Score | 9.5 score on a scale |
Secondary
Frequency of Low Back Pain
Frequency of Low Back Pain will be evaluated by asking patients Over the last 24 hours, how often were you in pain? Patients will be asked to respond to the frequency of their LBP over the prior 24 hours based on a 5-point Likert scale consisting of Not at all, Rarely, Sometimes, Usually, or Always. This question will help determine the burdensomeness of the LBP in the patient's daily life. Counts of participants reporting each frequency will be summarized.
Time frame: 7 days
Population: Data regarding Frequency of Low Back Pain was not collected.
Secondary
Frequency of Low Back Pain (LBP)
Frequency of Low Back Pain will be evaluated by asking patients Over the last 24 hours, how often were you in pain? Patients will be asked to respond to the frequency of their LBP over the prior 24 hours based on a 5-point Likert scale consisting of Not at all, Rarely, Sometimes, Usually, or Always. This question will help determine the burdensomeness of the LBP in the patient's daily life. Counts of participants reporting each frequency will be summarized.
Time frame: 48 hours
Population: Data regarding Frequency of Low Back Pain was not collected.
Secondary
Number of Visits to Any Healthcare Provider
The number of visits to any healthcare provider will be determined by asking patients whether they had any planned or emergent inpatient or outpatient visits to any healthcare provider for any reason during the course of the study. Group mean results will be summarized by treatment group.
Time frame: 48 hours
Population: Data related to the number of visits to any healthcare provider was not collected.
Secondary
Number of Visits to Any Healthcare Provider
The number of visits to any healthcare provider will be determined by asking patients whether they had any planned or emergent inpatient or outpatient visits to any healthcare provider for any reason during the course of the study. Group mean results will be summarized by treatment group.
Time frame: 7 days
Population: Data related to the number of visits to any healthcare provider was not collected.
Secondary
Return to Usual Activities
The percentage of patients who were able to return to usual activities following treatment will be quantified by asking patients to provide a binary Yes or No response to a question of whether they were able to return to day-to-day activities. Results will be summarized by treatment group.
Time frame: 48 hours
Population: Data related to the percentage of patients who were able to return to usual activities was not collected.
Secondary
Return to Usual Activities
The percentage of patients who were able to return to usual activities following treatment will be quantified by asking patients to provide a binary Yes or No response to a question of whether they were able to return to day-to-day activities. Results will be summarized by treatment group.
Time frame: 7 days
Population: Data related to the percentage of patients who were able to return to usual activities was not collected.
Secondary
Treatment Satisfaction
Patient satisfaction with the treatment they received will be assessed by their response to a binary Yes or No question regarding satisfaction with their treatment. Results will be summarized by treatment group.
Time frame: 48 hours
Population: Data related to treatment satisfaction was not collected.
Secondary
Treatment Satisfaction
Patient satisfaction with the treatment they received will be assessed by their response to a binary Yes or No question regarding satisfaction with their treatment. Results will be summarized by treatment group.
Time frame: 7 days
Population: Data related to treatment satisfaction was not collected.
Secondary
Use of Medication for Low Back Pain (LBP)
Participants were asked During the last 24 hours, have you taken any medication at all for low back pain? and asked to respond either Yes or No. Counts of participants using medication during the prior 24 hours are summarized.
Time frame: 48 hours
Population: 5 participants in the 'Oral ibuprofen + topical diclofenac' group; 6 participants in the 'Oral ibuprofen + topical placebo' group; and 3 participants in the 'Oral placebo and topical diclofenac' group were LTFU prior to 48 hour assessment timepoints; however, data was able to be collected from 3 LTFU participants in the Ibuprofen + Diclofenac group. Data was also not collected from 1 other participant in the 'Diclofenac + Placebo' group.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Oral Ibuprofen + Topical Diclofenac | Use of Medication for Low Back Pain (LBP) | Yes | 54 Participants |
| Oral Ibuprofen + Topical Diclofenac | Use of Medication for Low Back Pain (LBP) | No | 9 Participants |
| Oral Ibuprofen + Topical Placebo | Use of Medication for Low Back Pain (LBP) | Yes | 53 Participants |
| Oral Ibuprofen + Topical Placebo | Use of Medication for Low Back Pain (LBP) | No | 7 Participants |
| Oral Placebo + Topical Diclofenac | Use of Medication for Low Back Pain (LBP) | Yes | 50 Participants |
| Oral Placebo + Topical Diclofenac | Use of Medication for Low Back Pain (LBP) | No | 12 Participants |
Secondary
Use of Medication for Low Back Pain (LBP)
Participants were asked During the last 24 hours, have you taken any medication at all for low back pain? and asked to respond either Yes or No. Counts of participants using medication during the prior 24 hours are summarized.
Time frame: 7 days
Population: 5 participants in the 'Oral ibuprofen + topical diclofenac' group; 6 participants in the 'Oral ibuprofen + topical placebo' group; and 3 participants in the 'Oral placebo and topical diclofenac' group were lost to follow-up prior to the 7 day assessment timepoints; however data was able to be collected from 1 of the LTFU participants in the 'Ibuprofen + Diclofenac' group.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Oral Ibuprofen + Topical Diclofenac | Use of Medication for Low Back Pain (LBP) | Yes | 33 Participants |
| Oral Ibuprofen + Topical Diclofenac | Use of Medication for Low Back Pain (LBP) | No | 28 Participants |
| Oral Ibuprofen + Topical Placebo | Use of Medication for Low Back Pain (LBP) | Yes | 31 Participants |
| Oral Ibuprofen + Topical Placebo | Use of Medication for Low Back Pain (LBP) | No | 29 Participants |
| Oral Placebo + Topical Diclofenac | Use of Medication for Low Back Pain (LBP) | Yes | 35 Participants |
| Oral Placebo + Topical Diclofenac | Use of Medication for Low Back Pain (LBP) | No | 28 Participants |
Secondary
Worst Low Back Pain (LBP)
Worst low back was evaluated by asking patients How would you describe your worst low back pain in the last 24 hours? Patients were asked to describe their worst LBP using the terms Severe, Moderate, Mild, or None. Counts of participants reporting each degree of severity over the prior 24 hours are summarized.
Time frame: 7 days
Population: 5 participants in the 'Oral ibuprofen + topical diclofenac' group; 6 participants in the 'Oral ibuprofen + topical placebo' group; and 3 participants in the 'Oral placebo and topical diclofenac' group were lost to follow-up prior to the 7 day assessment timepoints; however data was able to be collected from 1 of the LTFU participants in the 'Ibuprofen + Diclofenac' group. Data was also not collected from 1 other participant in the 'Diclofenac + Placebo' group.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Oral Ibuprofen + Topical Diclofenac | Worst Low Back Pain (LBP) | None | 20 Participants |
| Oral Ibuprofen + Topical Diclofenac | Worst Low Back Pain (LBP) | Mild | 21 Participants |
| Oral Ibuprofen + Topical Diclofenac | Worst Low Back Pain (LBP) | Moderate | 13 Participants |
| Oral Ibuprofen + Topical Diclofenac | Worst Low Back Pain (LBP) | Severe | 7 Participants |
| Oral Ibuprofen + Topical Placebo | Worst Low Back Pain (LBP) | Severe | 4 Participants |
| Oral Ibuprofen + Topical Placebo | Worst Low Back Pain (LBP) | None | 24 Participants |
| Oral Ibuprofen + Topical Placebo | Worst Low Back Pain (LBP) | Moderate | 9 Participants |
| Oral Ibuprofen + Topical Placebo | Worst Low Back Pain (LBP) | Mild | 23 Participants |
| Oral Placebo + Topical Diclofenac | Worst Low Back Pain (LBP) | Severe | 7 Participants |
| Oral Placebo + Topical Diclofenac | Worst Low Back Pain (LBP) | Mild | 24 Participants |
| Oral Placebo + Topical Diclofenac | Worst Low Back Pain (LBP) | Moderate | 16 Participants |
| Oral Placebo + Topical Diclofenac | Worst Low Back Pain (LBP) | None | 15 Participants |
Secondary
Worst Low Back Pain (LBP)
Worst low back was evaluated by asking patients How would you describe your worst low back pain in the last 24 hours? Patients were asked to describe their worst LBP using the terms Severe, Moderate, Mild, or None. Counts of participants reporting each degree of severity over the prior 24 hours are summarized.
Time frame: 48 hours
Population: 5 participants in the 'Oral ibuprofen + topical diclofenac' group; 6 participants in the 'Oral ibuprofen + topical placebo' group; and 3 participants in the 'Oral placebo and topical diclofenac' group were lost to follow-up prior to the 48 hour assessment timepoints; however, data was able to be collected from 3 LTFU participants in the Ibuprofen + Diclofenac group.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Oral Ibuprofen + Topical Diclofenac | Worst Low Back Pain (LBP) | None | 5 Participants |
| Oral Ibuprofen + Topical Diclofenac | Worst Low Back Pain (LBP) | Mild | 27 Participants |
| Oral Ibuprofen + Topical Diclofenac | Worst Low Back Pain (LBP) | Moderate | 18 Participants |
| Oral Ibuprofen + Topical Diclofenac | Worst Low Back Pain (LBP) | Severe | 13 Participants |
| Oral Ibuprofen + Topical Placebo | Worst Low Back Pain (LBP) | Severe | 7 Participants |
| Oral Ibuprofen + Topical Placebo | Worst Low Back Pain (LBP) | None | 11 Participants |
| Oral Ibuprofen + Topical Placebo | Worst Low Back Pain (LBP) | Moderate | 14 Participants |
| Oral Ibuprofen + Topical Placebo | Worst Low Back Pain (LBP) | Mild | 28 Participants |
| Oral Placebo + Topical Diclofenac | Worst Low Back Pain (LBP) | Severe | 11 Participants |
| Oral Placebo + Topical Diclofenac | Worst Low Back Pain (LBP) | Mild | 21 Participants |
| Oral Placebo + Topical Diclofenac | Worst Low Back Pain (LBP) | Moderate | 23 Participants |
| Oral Placebo + Topical Diclofenac | Worst Low Back Pain (LBP) | None | 8 Participants |