Acute Low Back Pain. Topical Diclofenac and Oral Ibuprofen.

Montefiore Medicine Academic Health System

Status and phase: Completed; Phase 4

Conditions: Low Back Pain

Treatments: Drug: Ibuprofen 400 mg; Drug: Topical diclofenac

Study type: Interventional

Funder types: Other

Identifiers

NCT04611529

2020-12418

Details and patient eligibility

About

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.

Enrollment: 198 patients

Sex: All

Ages: 18 to 69 years old

Volunteers: No Healthy Volunteers

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)

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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198 participants in 3 patient groups

Oral ibuprofen + topical diclofenac

Experimental group

Description:

Oral ibuprofen 400mg Topical diclofenac 4gm

Treatment:

Drug: Topical diclofenac

Drug: Ibuprofen 400 mg

Oral ibuprofen + topical placebo

Active Comparator group

Description:

Oral ibuprofen 400mg Topical placebo

Treatment:

Drug: Ibuprofen 400 mg

Oral placebo + topical diclofenac

Active Comparator group

Description:

Oral placebo Topical diclofenac 4gm

Treatment:

Drug: Topical diclofenac