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NonNarcotic Pain Control

NonNarcotic Pain Control for Elbow Pain

Phase 4
Recruiting
Led By Michael Dakkak, DO
Research Sponsored by The Cleveland Clinic
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Undergoing Percutaneous Needle Tenotomy of Lateral Elbow Procedure
Musculoskeletal ultrasound or MRI with diagnosis of tendinosis of the common extensor tendon of the elbow
Must not have
No history of inflammatory arthritis, diabetes, chronic regional pain syndrome, connective tissue disease, fibromyalgia or autoimmune disease
No contraindications to NSAIDs or Opioids
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 10 days
Awards & highlights
Pivotal Trial
Drug Has Already Been Approved

Summary

This trial is looking at whether taking oral Diclofenac or Tramadol can help reduce the need for narcotic pills after a procedure on the elbow. They want to see if patients who

Who is the study for?
This trial is for individuals experiencing chronic elbow pain who are undergoing a specific minimally invasive procedure called percutaneous needle tenotomy. Participants should not have used narcotic pills before the surgery and must be willing to take either Diclofenac or Tramadol as part of the study.
What is being tested?
The study tests whether Diclofenac, a non-narcotic pain reliever, can reduce the need for narcotics after elbow surgery compared to Tramadol, which has narcotic-like effects. Patients will be randomly assigned to one of these medications in a blinded manner.
What are the potential side effects?
Diclofenac may cause stomach upset, headache, dizziness, or liver issues. Tramadol could lead to nausea, drowsiness, constipation or dependency issues.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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I am having a procedure for tennis elbow using needles.
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My elbow tendon shows wear without tears on an ultrasound or MRI.
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I am between 18 and 65 years old.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:
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I do not have inflammatory arthritis, diabetes, chronic pain syndromes, connective tissue disease, fibromyalgia, or autoimmune diseases.
Select...
I can safely take NSAIDs and opioids.
Select...
I have a complete tear in the tendon near my elbow.
Select...
I have had elbow surgery in the past.
Select...
I have a mental health condition that affects how my pain or medication use is assessed.
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I have neck pain that spreads into my arm or hand.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~10 days
This trial's timeline: 3 weeks for screening, Varies for treatment, and 10 days for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
Number of pills taken
Secondary study objectives
Non narcotic use

Awards & Highlights

Pivotal Trial
The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.
Drug Has Already Been Approved
The FDA has already approved this drug, and is just seeking more data.

Trial Design

3Treatment groups
Active Control
Placebo Group
Group I: TramadolActive Control2 Interventions
50mg
Group II: DiclofenacActive Control2 Interventions
50mg
Group III: AcetaminophenPlacebo Group1 Intervention
1000mg

Find a Location

Who is running the clinical trial?

The Cleveland ClinicLead Sponsor
1,052 Previous Clinical Trials
1,371,022 Total Patients Enrolled
8 Trials studying Chronic Pain
1,406 Patients Enrolled for Chronic Pain
Michael Dakkak, DOPrincipal InvestigatorCleveland Clinic Florida
~59 spots leftby Jul 2025
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