Phase 4
Completed N=197
Acute Low Back Pain. Topical Diclofenac and Oral Ibuprofen.
Source: ClinicalTrials.gov NCT04611529 ↗Enrolled (actual)
197
Serious AEs
0.0%
Results posted
Oct 2024
Primary outcomePrimary: Change in Pain Disability - Roland Morris Disability Questionnaire (RMDQ) Score — 8.7; 10.1; 6.4 score on a scale
◆ Published Evidence
No publication linked
No peer-reviewed publication reporting this trial's results has been linked yet. This can indicate results are unpublished — a known publication-bias signal. We re-check periodically.
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.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Change in Pain Disability - Roland Morris Disability Questionnaire (RMDQ) Score |
10.7; 12.2; 9.5 | — |
| SECONDARY Worst Low Back Pain (LBP) |
20; 24; 15; 21; 23; 24 | — |
| SECONDARY Use of Medication for Low Back Pain (LBP) |
33; 31; 35; 28; 29; 28 | — |
| SECONDARY Frequency of Low Back Pain (LBP) |
— | — |
| SECONDARY Return to Usual Activities |
— | — |
| SECONDARY Number of Visits to Any Healthcare Provider |
— | — |
| SECONDARY Treatment Satisfaction |
— | — |
| SECONDARY Change in Pain Disability - Roland Morris Disability Questionnaire (RMDQ) Score |
10.7; 12.2; 9.5 | — |
| SECONDARY Frequency of Low Back Pain |
— | — |
Eligibility Criteria
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 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)
Data sourced from ClinicalTrials.gov (NCT04611529). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.