Acute Low Back Pain. Topical Diclofenac and Oral Ibuprofen.
Primary Purpose
Low Back Pain
Status
Recruiting
Phase
Phase 4
Locations
United States
Study Type
Interventional
Intervention
Ibuprofen 400 mg
Topical diclofenac
Sponsored by
About this trial
This is an interventional treatment trial for Low Back Pain
Eligibility Criteria
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)
Sites / Locations
- MontefioreRecruiting
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm Type
Experimental
Active Comparator
Active Comparator
Arm Label
Oral ibuprofen + topical diclofenac
Oral ibuprofen + topical placebo
Oral placebo + topical diclofenac
Arm Description
Oral ibuprofen 400mg Topical diclofenac 2gm
Oral ibuprofen 400mg Topical placebo
Oral placebo Topical diclofenac 2gm
Outcomes
Primary Outcome Measures
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)
Secondary Outcome Measures
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
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
Full Information
NCT ID
NCT04611529
First Posted
October 28, 2020
Last Updated
February 21, 2023
Sponsor
Montefiore Medical Center
1. Study Identification
Unique Protocol Identification Number
NCT04611529
Brief Title
Acute Low Back Pain. Topical Diclofenac and Oral Ibuprofen.
Official Title
A Randomized Study of Topical Diclofenac Versus Oral Ibuprofen for Acute Non-radicular Low Back Pain
Study Type
Interventional
2. Study Status
Record Verification Date
February 2023
Overall Recruitment Status
Recruiting
Study Start Date
March 2, 2021 (Actual)
Primary Completion Date
December 2023 (Anticipated)
Study Completion Date
December 2023 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Montefiore Medical Center
4. Oversight
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
Data Monitoring Committee
Yes
5. Study Description
Brief 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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Low Back Pain
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
198 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Oral ibuprofen + topical diclofenac
Arm Type
Experimental
Arm Description
Oral ibuprofen 400mg Topical diclofenac 2gm
Arm Title
Oral ibuprofen + topical placebo
Arm Type
Active Comparator
Arm Description
Oral ibuprofen 400mg Topical placebo
Arm Title
Oral placebo + topical diclofenac
Arm Type
Active Comparator
Arm Description
Oral placebo Topical diclofenac 2gm
Intervention Type
Drug
Intervention Name(s)
Ibuprofen 400 mg
Intervention Description
Ibuprofen 400mg
Intervention Type
Drug
Intervention Name(s)
Topical diclofenac
Intervention Description
Diclofenac 1% gel 4gm
Primary Outcome Measure Information:
Title
Improvement in Roland Morris Disability Questionnaire
Description
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)
Time Frame
48 hours
Secondary Outcome Measure Information:
Title
Moderate or severe low back pain
Description
Participants will be asked to describe their worst pain over the previous 24 hours using the terms severe, moderate, mild, or none
Time Frame
48 hours
Title
Use of medication for low back pain
Description
Participants will be asked if they used any medication for low back pain in the previous 24 hours
Time Frame
48 hours
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
69 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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)
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Benjamin W Friedman, MD
Phone
718-920-6626
Email
befriedm@montefiore.org
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Benjamin Friedman, MD
Organizational Affiliation
Montefiore Medical Center
Official's Role
Principal Investigator
Facility Information:
Facility Name
Montefiore
City
New York
State/Province
New York
ZIP/Postal Code
10026
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Benjamin Friedman, MD
Phone
718-920-6626
Email
befriedm@montefiore.org
12. IPD Sharing Statement
Plan to Share IPD
No
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Acute Low Back Pain. Topical Diclofenac and Oral Ibuprofen.
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