Acute Low Back Pain. Topical Diclofenac and Oral Ibuprofen.

Low Back Pain Clinical Trial

Official title:

A Randomized Study of Topical Diclofenac Versus Oral Ibuprofen for Acute Non-radicular Low Back Pain

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04611529
• Other study ID #: 2020-12418
• Status: Completed
• Phase: Phase 4
• Start date: March 2, 2021
• Est. completion date: June 30, 2023

Study information

• Verified date: January 2024
• Source: Montefiore Medical Center
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

This is a randomized, double-blind 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. We will determine outcomes 2 days later.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 198
• Est. completion date: June 30, 2023
• Est. primary completion date: June 30, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 69 Years

Eligibility

Inclusion Criteria:

• Present to ED primary for management of 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)

Related Conditions & MeSH terms

• Back Pain
• Low Back Pain

Intervention

Drug:
• Ibuprofen 400 mg
Ibuprofen 400mg
• Topical diclofenac
Diclofenac 1% gel 4gm

Locations

Country	Name	City	State
United States	Montefiore	New York	New York

Sponsors (1)

Lead Sponsor	Collaborator
Montefiore Medical Center

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Improvement in Roland Morris Disability Questionnaire	The Roland-Morris 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)	48 hours
Secondary	Moderate or severe low back pain	Participants will be asked to describe their worst pain over the previous 24 hours using the terms severe, moderate, mild, or none	48 hours
Secondary	Use of medication for low back pain	Participants will be asked if they used any medication for low back pain in the previous 24 hours	48 hours