NCT06373978 NonNarcotic Pain Control in Percutaneous Needle Tenotomy of Elbow
| NCT ID | NCT06373978 |
| Status | Recruiting |
| Phase | Phase 4 |
| Sponsor | The Cleveland Clinic |
| Condition | Elbow Pain |
| Study Type | INTERVENTIONAL |
| Enrollment | 92 participants |
| Start Date | 2024-08-12 |
| Primary Completion | 2026-06-30 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
Phase 4 studies follow an already-approved treatment in real-world conditions to monitor long-term safety and effectiveness.
This trial targets 92 participants in total. It began in 2024-08-12 with a primary completion date of 2026-06-30.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
This study is a double-blind, randomized controlled trial comparing the effectiveness of oral acetaminophen, diclofenac, and tramadol in reducing the consumption of narcotic doses (primary outcome) and minimizing patients' exposure to narcotics (secondary outcome) following an ultrasound-guided percutaneous needle tenotomy procedure on the lateral elbow.
Eligibility 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
Contact & Investigator
Michael Dakkak, DO
PRINCIPAL INVESTIGATOR
Cleveland Clinic Florida
Frequently Asked Questions
Who can join the NCT06373978 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, up to 65 Years, studying Elbow Pain. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
What phase is the NCT06373978 trial and what does that mean for participants?
Phase 4 studies are conducted after a treatment has been approved. They monitor long-term safety and real-world effectiveness in a broader patient population.
Is NCT06373978 currently recruiting?
Yes, NCT06373978 is actively recruiting participants. Contact the research team at clancye@ccf.org for enrollment information.
Where is the NCT06373978 trial being conducted?
This trial is being conducted at Coral Springs, United States, Avon, United States.
Who is sponsoring the NCT06373978 clinical trial?
NCT06373978 is sponsored by The Cleveland Clinic. The principal investigator is Michael Dakkak, DO at Cleveland Clinic Florida. The trial plans to enroll 92 participants.