Comparing Connective Tissue Matrix and Steroid Injections for Shoulder Pain
Connective Tissue Matrix (CTM) Compared to Corticosteroid Injections: A Pilot Randomized Controlled Trial
NA · Allegheny Singer Research Institute (also known as Allegheny Health Network Research Institute) · NCT06712290
This study is testing whether a new injection made from connective tissue can help people with shoulder pain from rotator cuff issues better than a standard steroid injection.
Quick facts
| Phase | NA |
|---|---|
| Study type | Interventional |
| Enrollment | 52 (estimated) |
| Ages | 18 Years to 80 Years |
| Sex | All |
| Sponsor | Allegheny Singer Research Institute (also known as Allegheny Health Network Research Institute) (other) |
| Locations | 1 site (Pittsburgh, Pennsylvania) |
| Trial ID | NCT06712290 on ClinicalTrials.gov |
What this trial studies
This clinical trial aims to evaluate the effectiveness of a single injection of Connective Tissue Matrix (CTM) compared to a corticosteroid injection for treating rotator cuff tendinopathy. Patients will be randomly assigned to receive either CTM or Kenalog-40 (a corticosteroid), and both patients and researchers will be blinded to the treatment assignments. Participants will undergo follow-up assessments at 6 weeks, 3 months, and 6 months, which will include physical exams, questionnaires, and functional tests to evaluate shoulder performance. The study will collect data on patient outcomes and any adverse events throughout the trial period.
Who should consider this trial
Good fit: Ideal candidates are adults aged 18-80 with a diagnosis of rotator cuff tendinopathy who are eligible for an injection treatment.
Not a fit: Patients with conditions such as adhesive capsulitis, significant joint issues, or those who have had recent shoulder surgery or steroid injections may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could provide a more effective treatment option for patients suffering from rotator cuff tendinopathy.
How similar studies have performed: Other studies have shown promise in using similar biologic treatments for musculoskeletal conditions, suggesting potential for success in this approach.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * Patients aged 18-80 years old with rotator cuff tendinopathy * A corticosteroid 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 a history of chronic steroid treatment for any medical reason * Patients with medical conditions that may affect healing, such as * End-stage renal disease * Uncontrolled diabetes * Peripheral vascular disease * Severe and/or systemic immunocompromising conditions such as Lupus or HIV infection * Patients who are pregnant or breast feeding
Where this trial is running
Pittsburgh, Pennsylvania
- Allegheny Health Network Federal North Medical Office Building — Pittsburgh, Pennsylvania, United States (RECRUITING)
Study contacts
- Study coordinator: Clinical Trials
- Email: Clinicaltrials@ahn.org
- Phone: 1-877-660-6777
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.
Conditions: Rotator Cuff Tendinopathy, Shoulder, Rotator cuff, Tendinopathy