Efficacy of CTM for Tennis ELbow

Launched by INDIANA HAND TO SHOULDER CENTER · Dec 6, 2023

Keywords

ClinConnect Summary

This study is testing whether a single CTM injection (a connective tissue matrix made from human tissue) can help people with tennis elbow (lateral epicondylitis) more than the usual steroid injection. It’s a Phase 2, randomized, single-blind trial that compares two groups in parallel: one receives the standard corticosteroid shot, the other receives the CTM shot. The main goal is to see if CTM reduces elbow pain at 6 months, measured by the Patient-Related Tennis Elbow Evaluation (PRTEE) Pain Subscale. Researchers will also look at other outcomes at 6 months, including overall pain, how pain affects daily life, mood, grip strength, and how well the wrist can move.

Eligible participants are adults 18 and older with tennis elbow symptoms for at least 6 weeks who have not had meaningful improvement after 6 weeks of physical therapy and can return for follow-up visits. Key exclusions include prior outer-elbow surgery, certain inflammatory diseases, a recent elbow injection or trauma, being involved in workers’ compensation cases, or not speaking English. About 54 people are expected to enroll, with the study taking place at the Indiana Hand to Shoulder Center in Indianapolis. The injections are given at the area where pain is worst, using either the standard corticosteroid mix or the CTM product, and participants are blinded to which treatment they receive. The trial aims to complete around December 2025.

Gender

ALL

Eligibility criteria

• Inclusion Criteria:
• • 1. Males or females age 18 or older
• • 2. Patients presenting with symptomatic lateral epicondylitis for at least 6 weeks
• • 3. Patients who have not had a meaningful symptomatic improvement after 6 weeks of physical therapy
• • 4. Patients who can consent to be a part of this study
• • 5. Patients who are able to return to the Indiana Hand to Shoulder Center or a satellite location for follow up time points
• Exclusion Criteria:
• • 1. Previous surgery to the lateral side of the elbow
• • 2. Systemic inflammatory conditions (RA, psoriatic arthritis, lupus, etc)
• • 3. Previous elbow injection within the last 6 months
• • 4. History of recent elbow trauma
• • 5. Patients actively involved in workman's compensation cases
• • 6. Non-English Speaking Patients