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NonNarcotic Pain Control

Tramadol for Elbow Pain

Phase 4
Waitlist Available
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
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 10 days
Awards & highlights

Study 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.Check my eligibility
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.See study design
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.

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

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Number of pills taken
Secondary outcome measures
Non narcotic use

Trial Design

2Treatment groups
Active Control
Group I: TramadolActive Control1 Intervention
50mg
Group II: DiclofenacActive Control1 Intervention
50mg

Find a Location

Who is running the clinical trial?

The Cleveland ClinicLead Sponsor
1,030 Previous Clinical Trials
1,363,926 Total Patients Enrolled
Michael Dakkak, DOPrincipal InvestigatorCleveland Clinic Florida

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Are new participants still eligible to enroll in this ongoing clinical trial?

"According to clinicaltrials.gov, the current trial is not actively seeking subjects. The initial posting date was on June 1st, 2024 and the latest update occurred on April 16th, 2024. Although recruitment for this study is currently closed, it's worth noting that there are a total of 417 ongoing trials enrolling participants presently."

Answered by AI

What are the potential risks associated with Tramadol usage in individuals?

"Given that this investigation falls under Phase 4, indicating official approval of the treatment, our team rates Tramadol's safety at the highest level of 3."

Answered by AI

Which specific individuals are considered the ideal candidates for inclusion in this clinical trial?

"In order to be eligible for participation in this clinical study, patients must experience discomfort in their elbow and fall within the age bracket of 18 to 65 years. The trial aims to enroll approximately 92 participants."

Answered by AI

Is the study open to individuals below 35 years old?

"To be eligible for this research study, individuals must be between 18 and 65 years of age."

Answered by AI
~61 spots leftby Jun 2025