Acute Low Back Pain. Topical Diclofenac and Oral Ibuprofen.

NCT04611529 | Completed Phase 4 Results DMC FDA Drug

• 1 other identifier: 2020-12418
• Study Type: interventional
• Target: 198
• Locations: 1 country
• Sites: 1

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.

Conditions

Low Back Pain

Outcome Measures

Primary Outcomes (1)

• 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).

  Baseline to 48 hours

Secondary Outcomes (13)

• Worst Low Back Pain (LBP)

  48 hours

• Use of Medication for Low Back Pain (LBP)

  48 hours

• Frequency of Low Back Pain (LBP)

  48 hours

• Return to Usual Activities

  48 hours

• Number of Visits to Any Healthcare Provider

  48 hours

Study Arms (3)

Oral ibuprofen + topical diclofenac

EXPERIMENTAL

Oral ibuprofen 400mg Topical diclofenac 4gm

Drug: Ibuprofen 400 mg; Drug: Topical diclofenac

Oral ibuprofen + topical placebo

ACTIVE COMPARATOR

Oral ibuprofen 400mg Topical placebo

Drug: Ibuprofen 400 mg

Oral placebo + topical diclofenac

ACTIVE COMPARATOR

Oral placebo Topical diclofenac 4gm

Drug: Topical diclofenac

Interventions

Ibuprofen 400 mg DRUG

Ibuprofen 400mg

Oral ibuprofen + topical diclofenac; Oral ibuprofen + topical placebo

Topical diclofenac DRUG

Diclofenac 1% gel 4gm

Oral ibuprofen + topical diclofenac; Oral placebo + topical diclofenac

Eligibility Criteria

• Age: 18 Years - 69 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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)

Sponsors & Collaborators

• Montefiore Medical Center: lead

Study Sites (1)

Montefiore

New York, New York, 10026, United States

Location

MeSH Terms

Conditions

Low Back Pain

Interventions

Ibuprofen; Diclofenac

Condition Hierarchy (Ancestors)

Back Pain; Pain; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Phenylpropionates; Acids, Carbocyclic; Carboxylic Acids; Organic Chemicals; Phenylacetates

Results Point of Contact

• Title: Dr. Benjamin Friedman
• Organization: Montefiore Medical Center

befriedm@montefiore.org

718-920-6626

Study Officials

• Benjamin Friedman, MD

  Montefiore Medical Center

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 28, 2020
• First Posted: November 2, 2020
• Study Start: March 2, 2021
• Primary Completion: June 30, 2023
• Study Completion: June 30, 2023
• Last Updated: October 9, 2024
• Results First Posted: October 9, 2024

Record last verified: 2024-10

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)