Acute Low Back Pain. Topical Diclofenac and Oral Ibuprofen.

Montefiore Medical Center198 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

QUADRUPLE

Enrollment

198

Conditions

Low Back Pain

Interventions

Ibuprofen 400 mgDRUG

Ibuprofen 400mg

Topical diclofenacDRUG

Diclofenac 1% gel 4gm

Eligibility

Sex: ALLMin age: 18 YearsMax age: 69 Years

Medical Language ↔ Plain English

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)

Locations (1)

Montefiore

New York, New York, United States

Outcomes

Primary Outcomes

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

Secondary Outcomes

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

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

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

Return to Usual Activities

Data from ClinicalTrials.gov

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