drugset / Trial / NCT04136743

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

NCT04136743 ↗

Phase 2 Unknown 24 enrolled Kessler Foundation
RandomizedParallel-groupSingle-blindTreatment

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.

Timeline

Start
2019-06-14
Primary completion
2023-04-30
Completion
2024-04-30

Drugs

EvaluationDrugModalityDoseRoute
Comparator Dexamethasone Small molecule 40 mg Other