Acute Low Back Pain. Topical Diclofenac and Oral Ibuprofen.

  • STATUS
    Recruiting
  • End date
    Dec 23, 2023
  • participants needed
    198
  • sponsor
    Montefiore Medical Center
Updated on 23 March 2021

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.

Details
Condition Low Back Pain, Back Pain, Chronic Back Pain, Lower Back Pain, lumbago
Treatment Ibuprofen 400 mg, Topical diclofenac, Topical diclofenac
Clinical Study IdentifierNCT04611529
SponsorMontefiore Medical Center
Last Modified on23 March 2021

Eligibility

Yes No Not Sure

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)
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