Acute Low Back Pain. Topical Diclofenac and Oral Ibuprofen.

NCT ID: NCT04611529

Last Updated: 2024-10-09

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE4
• Total Enrollment: 198 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2021-03-02
• Study Completion Date: 2023-06-30

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

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: QUADRUPLE

Study Groups

Oral ibuprofen + topical diclofenac

Oral ibuprofen 400mg Topical diclofenac 4gm

Group Type: EXPERIMENTAL

Ibuprofen 400 mg

Intervention Type: DRUG

Ibuprofen 400mg

Topical diclofenac

Intervention Type: DRUG

Diclofenac 1% gel 4gm

Oral ibuprofen + topical placebo

Oral ibuprofen 400mg Topical placebo

Group Type: ACTIVE_COMPARATOR

Ibuprofen 400 mg

Intervention Type: DRUG

Ibuprofen 400mg

Oral placebo + topical diclofenac

Oral placebo Topical diclofenac 4gm

Group Type: ACTIVE_COMPARATOR

Topical diclofenac

Intervention Type: DRUG

Diclofenac 1% gel 4gm

Interventions

Ibuprofen 400 mg

Ibuprofen 400mg

Intervention Type: DRUG

Topical diclofenac

Diclofenac 1% gel 4gm

Intervention Type: DRUG

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)

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 69 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Montefiore Medical Center

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Benjamin Friedman, MD

Role: PRINCIPAL_INVESTIGATOR

Montefiore Medical Center

Locations

Montefiore

New York, New York, United States

Countries

United States

Provided Documents

Document Type: Study Protocol and Statistical Analysis Plan

View Document

Document Type: Informed Consent Form

View Document

Other Identifiers

2020-12418

Identifier Type: -

Identifier Source: org_study_id