Acute Low Back Pain. Topical Diclofenac and Oral Ibuprofen.

Phase 4

Completed

Conditions: Low Back Pain

Interventions: Drug: Ibuprofen 400 mg
Drug: Topical diclofenac

Registration Number: NCT04611529

Lead Sponsor: Montefiore Medical Center

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.

Detailed Description: Not available

Recruitment & Eligibility

Status: COMPLETED

Sex: All

Target Recruitment: 198

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)

Study & Design

Study Type: INTERVENTIONAL

Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Oral ibuprofen + topical diclofenac	Ibuprofen 400 mg	Oral ibuprofen 400mg Topical diclofenac 4gm
Oral ibuprofen + topical diclofenac	Topical diclofenac	Oral ibuprofen 400mg Topical diclofenac 4gm
Oral ibuprofen + topical placebo	Ibuprofen 400 mg	Oral ibuprofen 400mg Topical placebo
Oral placebo + topical diclofenac	Topical diclofenac	Oral placebo Topical diclofenac 4gm

Primary Outcome Measures

Name	Time	Method
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 Outcome Measures

Name	Time	Method
Worst Low Back Pain (LBP)	7 days	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)	7 days	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	7 days	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	7 days	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	7 days	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.