Ultrasound-Guided Treatments for Shoulder Pain in Wheelchair Users With Spinal Cord Injury

• Status: Recruiting
• Trial end date: 2022-04-30
• Target enrollment: 0
• Participant gender: All

Summary

Rotator cuff disease (i.e., rotator cuff tendinopathy or tear) is a common cause of shoulder pain in persons with chronic spinal cord injury (SCI). It usually resolves with non-operative treatments such as pharmacological agents and physical therapy; however, when this fails, rotator cuff surgery may be the only option. Corticosteroid injections are another alternative to provide temporary relief, but can over time accelerate degeneration of the tendon and lead to further damage. Autologous adipose tissue injection has recently emerged as a promising new treatment for joint pain and soft tissue injury. Adipose can be used to provide cushioning and filling of structural defects and has been shown to have an abundance of bioactive elements and regenerative perivascular cells (pericytes). The purpose of this study is to explore the efficacy of autologous, micro-fragmented adipose tissue (Lipogems®) injection under ultrasound guidance for chronic shoulder pain in persons with SCI compared with the standard-of-care, corticosteroid injection.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Kessler Foundation
• Treatments: Dexamethasone; Triamcinolone Acetonide

Criteria

Inclusion Criteria:

• Men and women, 18 to 70 years of age, inclusive

• Neurological impairment secondary to a spinal cord injury or disorder that occurred at least twelve (12) months prior to the Screening Visit and the level of the injury is between C6 and L5, inclusive

• Non-ambulatory except for exercise purposes and uses a manual or power wheelchair as his/her primary means of mobility (> 40 hours/week)

• Currently has chronic shoulder pain due to rotator cuff disease in spite of at least 6 months of conservative treatment

• Average shoulder pain intensity during the week leading up to the Screening Visit is at least 4 out of 10 on an 11-point numerical rating scale (NRS; 0, no pain; 10, maximum pain imaginable).

• Rotator cuff disease will be defined as pain over the anterior shoulder, with direct palpation and pain at the shoulder with provocative tests for rotator cuff disease that is confirmed by tendinopathic changes on ultrasound imaging.

Exclusion Criteria:

• Report prior MFAT treatment

• Have a history of systemic disorders, such as diabetes or rheumatoid arthritis

• Have a contra-indication to the procedure, such as infection, coagulopathy, or currently taking anti-coagulant

• Report having a glucocorticoid injection in the past 4 weeks

• Are pregnant

• Have any medical condition, including psychiatric disease, which would interfere with the interpretation of the study results or the conduct of the study