Fat Tissue Injection vs Corticosteroid Injection for Shoulder Pain in Spinal Cord Injury
(MFAT-SCI Trial)
What You Need to Know Before You Apply
What is the purpose of this trial?
This trial uses a patient's own processed fat to treat shoulder pain in people with spinal cord injuries who haven't improved with other treatments. The fat helps heal the shoulder by providing cushioning and regenerative cells.
Will I have to stop taking my current medications?
The trial protocol does not specify whether you need to stop taking your current medications. However, if you are currently taking anti-coagulants or have had a glucocorticoid injection in the past 4 weeks, you may not be eligible to participate.
Is fat tissue injection safe for treating shoulder pain in spinal cord injury?
How does the treatment Lipogems differ from other treatments for shoulder pain in spinal cord injury?
Lipogems is unique because it uses fat tissue injections, which can provide a source of progenitor cells and deliver therapeutic genes, potentially reducing inflammation and promoting tissue repair. This approach is different from traditional corticosteroid injections, which primarily focus on reducing inflammation without the regenerative potential of fat tissue.34567
What data supports the effectiveness of the treatment for shoulder pain in spinal cord injury patients?
The research shows that corticosteroid injections, which are part of the treatment being studied, are confirmed therapies for shoulder pain in spinal cord injury patients. Additionally, micro-fragmented adipose tissue injections have been explored for their safety and potential benefits in treating shoulder pain in similar populations.89101112
Are You a Good Fit for This Trial?
This trial is for adults aged 18-70 with chronic shoulder pain due to rotator cuff disease, who have had a spinal cord injury between C6 and L5 at least one year ago. Participants must be wheelchair users (over 40 hours/week) and have not found relief from pain after six months of conservative treatment. They cannot join if they have systemic disorders like diabetes or rheumatoid arthritis, previous adipose tissue injections, contraindications like infection or coagulopathy, are pregnant, or recently had corticosteroid injections.Inclusion Criteria
Exclusion Criteria
Timeline for a Trial Participant
Screening
Participants are screened for eligibility to participate in the trial
Treatment
Participants receive either a micro-fragmented adipose tissue injection or a corticosteroid injection under ultrasound guidance
Rehabilitation
Participants follow a standardized stretching protocol for 4 weeks followed by a formal strengthening program
Follow-up
Participants are monitored for adverse events and changes in shoulder pain intensity, with assessments at 1, 2, 3, and 6 months post-treatment
What Are the Treatments Tested in This Trial?
Interventions
- Dexamethasone
- Lipogems
Find a Clinic Near You
Who Is Running the Clinical Trial?
Kessler Foundation
Lead Sponsor