Clinical trial NCT04611529: Acute Low Back Pain. Topical Diclofenac and Oral Ibuprofen.
Official title: A Randomized Study of Topical Diclofenac Versus Oral Ibuprofen for Acute Non-radicular Low Back Pain
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Low Back Pain
Lead sponsor: Montefiore Medical Center
Sponsor class: OTHER
First posted: 2020-11-02
Enrollment: 198
Sex: ALL
Minimum age (years): 18
Maximum age (years): 69
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


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 \<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)

Primary outcomes:
measure: Change in Pain Disability - Roland Morris Disability Questionnaire (RMDQ) Score
timeFrame: Baseline to 48 hours
Secondary outcomes:
measure: Worst Low Back Pain (LBP)
timeFrame: 48 hours
measure: Use of Medication for Low Back Pain (LBP)
timeFrame: 48 hours
measure: Frequency of Low Back Pain (LBP)
timeFrame: 48 hours
measure: Return to Usual Activities
timeFrame: 48 hours
measure: Number of Visits to Any Healthcare Provider
timeFrame: 48 hours
measure: Treatment Satisfaction
timeFrame: 48 hours
measure: Change in Pain Disability - Roland Morris Disability Questionnaire (RMDQ) Score
timeFrame: 7 days
measure: Worst Low Back Pain (LBP)
timeFrame: 7 days
measure: Use of Medication for Low Back Pain (LBP)
timeFrame: 7 days
measure: Frequency of Low Back Pain
timeFrame: 7 days
measure: Return to Usual Activities
timeFrame: 7 days
measure: Number of Visits to Any Healthcare Provider
timeFrame: 7 days
measure: Treatment Satisfaction
timeFrame: 7 days
Other outcomes:
Locations:
city: New York
country: United States
facility: Montefiore
state: New York
Study officials:
affiliation: Montefiore Medical Center
name: Benjamin Friedman, MD
role: PRINCIPAL_INVESTIGATOR
References: