Non-narcotic pain control after elbow tenotomy
Official title: A Randomized Controlled Trial: Alternative Post Procedural Analgesia With NSAIDs vs Opioids in Percutaneous Needle Tenotomy of Elbow
Run by The Cleveland Clinic · NCT06373978 · Data updated 2026-11-12
This study is testing whether taking acetaminophen, diclofenac, or tramadol can help people manage pain after a specific elbow procedure while reducing the need for stronger narcotics.
Quick facts
| Phase | Phase 4 |
|---|---|
| Study type | Interventional |
| Ages | 18 Years to 65 Years |
| Sex | All |
| Enrollment | 92 (estimated) |
| Sponsor | The Cleveland Clinic Academic / other |
| Locations | 2 sites (Coral Springs, Florida and 1 other locations) |
| Status | Recruiting |
| Started | August 12, 2024 |
| Main results expected | June 30, 2027 |
| Study ends | June 30, 2027 |
| Registry record updated | August 28, 2026 |
| Trial ID | NCT06373978 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a good fit
Ideal candidates are adults aged 18-65 with a diagnosis of tendinosis of the common extensor tendon of the elbow who are undergoing a percutaneous needle tenotomy.
✕Probably not a fit
Patients with a full thickness common extensor tendon tear, prior elbow surgery, or other significant medical conditions may not benefit from this study.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
What this trial studies
This clinical trial is a double-blind, randomized controlled trial that evaluates the effectiveness of oral acetaminophen, diclofenac, and tramadol in managing pain following an ultrasound-guided percutaneous needle tenotomy procedure on the lateral elbow. Participants will be randomly assigned to receive one of the pain medications, with tramadol being the current standard. The primary goal is to reduce the consumption of narcotics post-procedure, while secondary outcomes include minimizing overall narcotic exposure. Pain management will be monitored through pill counts and follow-up visits over a two-week period.
Why it matters
Potential benefit: If successful, this study could provide effective non-narcotic pain management options for patients undergoing elbow procedures.
How similar studies have gone: Other studies have shown promise in using non-narcotic pain management strategies, making this approach both relevant and potentially impactful.
Who can join: the full rules
Show full inclusion / exclusion criteria
Inclusion Criteria: * Provision of signed and dated informed consent form * Stated willingness to comply with all study procedures and availability for the duration of the study * Male or female, aged 18-65 years * Percutaneous Needle Tenotomy of Lateral Elbow Procedure * Ability to take oral medication and willingness to participate in a 2-week follow-up pill counts * Musculoskeletal ultrasound or MRI with diagnosis of tendinosis of the common extensor tendon of the elbow Exclusion Criteria: * • Any full thickness common extensor tendon tear of the elbow * Prior history of elbow surgery * Symptomatic cervical radiculopathy * Concurrent symptoms of the medial elbow * Treatment with another investigational drug or other intervention concurrently or previously that would interfere with postoperative pain control * Psychiatric illness that impedes evaluation of pain and/or narcotics use * No history of inflammatory arthritis, diabetes, chronic regional pain syndrome, connective tissue disease, fibromyalgia or autoimmune disease * No contraindications to NSAIDs or Opioids
Where it's running
-
The Cleveland Clinic Florida
Coral Springs, Florida, United States Recruiting -
The Cleveland Clinic Ohio
Avon, Ohio, United States Recruiting
Study contacts
- Principal investigator: Michael Dakkak, DO — Cleveland Clinic Florida
- Study coordinator: Erin Clancy, BA
- Email: clancye@ccf.org
- Phone: 2169706796
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How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.