Injecting connective tissue matrix for shoulder tendon pain
Connective Tissue Matrix (CTM) for Rotator Cuff Tendinopathy: A Randomized Controlled Trial
This study is testing whether a single injection of a new connective tissue treatment can help people with shoulder tendon pain feel better compared to a common treatment using platelet-rich plasma.
Quick facts
| Phase | Phase 4 |
|---|---|
| Study type | Interventional |
| Enrollment | 92 (estimated) |
| Ages | 18 Years to 80 Years |
| Sex | All |
| Sponsor | Allegheny Singer Research Institute (also known as Allegheny Health Network Research Institute) Academic / other |
| Locations | 4 sites (Pittsburgh, Pennsylvania and 3 other locations) |
| Trial ID | NCT06160427 on ClinicalTrials.gov |
What this trial studies
This research evaluates the effectiveness of a single injection of connective tissue matrix (CTM) Boost compared to platelet-rich plasma (PRP) in treating rotator cuff tendinopathy. The study aims to assess pain reduction and functional improvement at six months post-injection. Patients aged 18-80 with rotator cuff tendinopathy will be included, while those with certain shoulder conditions or recent surgeries will be excluded. The goal is to determine if CTM Boost is as effective as PRP in alleviating symptoms.
Who should consider this trial
Good fit: Ideal candidates are adults aged 18-80 diagnosed with rotator cuff tendinopathy who are willing to receive an injection.
Not a fit: Patients with adhesive capsulitis, significant shoulder joint issues, or recent shoulder surgeries may not benefit from this study.
Why it matters
Potential benefit: If successful, this treatment could provide a new non-surgical option for patients suffering from rotator cuff tendinopathy.
How similar studies have performed: Previous studies have shown promise with PRP injections for tendon healing, but the use of CTM is a novel approach.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * Patients aged 18-80 years old with rotator cuff tendinopathy * A PRP or CTM-type injection was determined by the clinician to be the proper medical treatment course and patient is willing to undergo the injection Exclusion Criteria: * Patients with adhesive capsulitis * Patients with acromio-clavicular joint impingement, retracted tears, significant labral lesions or significant glenohumeral arthrosis * Patients with joint instability * History of shoulder surgery or corticosteroid injection in the past 3 months * Patients with any medical conditions that affect healing, such as end-stage renal disease or uncontrolled diabetes
Where this trial is running
Pittsburgh, Pennsylvania and 3 other locations
- Allegheny Health Network Allegheny General Hospital — Pittsburgh, Pennsylvania, United States (Recruiting)
- Allegheny Health Network Federal North Medical Office Building — Pittsburgh, Pennsylvania, United States (Recruiting)
- AHN Wexford Health & Wellness Pavilion — Wexford, Pennsylvania, United States (Recruiting)
- AHN Wexford Hospital — Wexford, Pennsylvania, United States (Recruiting)
Study contacts
- Principal investigator: Patrick Demeo, MD — Allegheny Health Network
- Study coordinator: Patrick Demeo, MD
- Email: patrick.demeo@ahn.org
- Phone: 412-359-3895
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.