Non-narcotic pain control after elbow tenotomy
A Randomized Controlled Trial: Alternative Post Procedural Analgesia With NSAIDs vs Opioids in Percutaneous Needle Tenotomy of Elbow
PHASE4 · The Cleveland Clinic · NCT06373978
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 | PHASE4 |
|---|---|
| Study type | Interventional |
| Enrollment | 92 (estimated) |
| Ages | 18 Years to 65 Years |
| Sex | All |
| Sponsor | The Cleveland Clinic (other) |
| Locations | 2 sites (Coral Springs, Florida and 1 other locations) |
| Trial ID | NCT06373978 on ClinicalTrials.gov |
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.
Who should consider this trial
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.
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.
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 performed: Other studies have shown promise in using non-narcotic pain management strategies, making this approach both relevant and potentially impactful.
Eligibility criteria
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 this trial is running
Coral Springs, Florida and 1 other locations
- 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
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
Conditions: Elbow Pain, Chronic Pain, TenJet, Elbow