- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04611529
Acute Low Back Pain. Topical Diclofenac and Oral Ibuprofen.
January 15, 2024 updated by: Montefiore Medical Center
A Randomized Study of Topical Diclofenac Versus Oral Ibuprofen for Acute Non-radicular Low Back Pain
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.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Study Type
Interventional
Enrollment (Actual)
198
Phase
- Phase 4
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Contact
- Name: Benjamin W Friedman, MD
- Phone Number: 718-920-6626
- Email: befriedm@montefiore.org
Study Locations
-
-
New York
-
New York, New York, United States, 10026
- Montefiore
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years to 69 years (Adult, Older Adult)
Accepts Healthy Volunteers
No
Description
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)
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Quadruple
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Oral ibuprofen + topical diclofenac
Oral ibuprofen 400mg Topical diclofenac 2gm
|
Ibuprofen 400mg
Diclofenac 1% gel 4gm
|
Active Comparator: Oral ibuprofen + topical placebo
Oral ibuprofen 400mg Topical placebo
|
Ibuprofen 400mg
|
Active Comparator: Oral placebo + topical diclofenac
Oral placebo Topical diclofenac 2gm
|
Diclofenac 1% gel 4gm
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Improvement in Roland Morris Disability Questionnaire
Time Frame: 48 hours
|
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 Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Moderate or severe low back pain
Time Frame: 48 hours
|
Participants will be asked to describe their worst pain over the previous 24 hours using the terms severe, moderate, mild, or none
|
48 hours
|
Use of medication for low back pain
Time Frame: 48 hours
|
Participants will be asked if they used any medication for low back pain in the previous 24 hours
|
48 hours
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Principal Investigator: Benjamin Friedman, MD, Montefiore Medical Center
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
March 2, 2021
Primary Completion (Actual)
June 30, 2023
Study Completion (Actual)
June 30, 2023
Study Registration Dates
First Submitted
October 28, 2020
First Submitted That Met QC Criteria
October 28, 2020
First Posted (Actual)
November 2, 2020
Study Record Updates
Last Update Posted (Actual)
January 17, 2024
Last Update Submitted That Met QC Criteria
January 15, 2024
Last Verified
January 1, 2024
More Information
Terms related to this study
Additional Relevant MeSH Terms
- Pain
- Neurologic Manifestations
- Back Pain
- Low Back Pain
- Physiological Effects of Drugs
- Molecular Mechanisms of Pharmacological Action
- Peripheral Nervous System Agents
- Enzyme Inhibitors
- Analgesics
- Sensory System Agents
- Anti-Inflammatory Agents, Non-Steroidal
- Analgesics, Non-Narcotic
- Anti-Inflammatory Agents
- Antirheumatic Agents
- Cyclooxygenase Inhibitors
- Diclofenac
- Ibuprofen
Other Study ID Numbers
- 2020-12418
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
NO
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Yes
Studies a U.S. FDA-regulated device product
No
product manufactured in and exported from the U.S.
Yes
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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