Micro-Fragmented Adipose Tissue (Lipogems®) Injection for Chronic Shoulder Pain in Persons With Spinal Cord Injury
Unknown statusEarly phase 1NCT03167138
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This study has no listed site in Canada in this snapshot. It is included as part of the worldwide chronic pain corpus.
Brief summary (from the registry)
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. 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 safety and efficacy of autologous, micro-fragmented adipose tissue (Lipogems®) injection under ultrasound guidance for chronic shoulder pain in persons with SCI.
Study details
- Official title
- Treatment of Chronic Shoulder Pain in Persons With Spinal Cord Injury Using Injection With Autologous Micro-Fragmented Adipose Tissue Under Ultrasound Guidance
- Conditions
- Shoulder Pain
- Shoulder Impingement Syndrome
- Rotator Cuff Impingement Syndrome
- Rotator Cuff Tendinitis
- Rotator Cuff Syndrome of Shoulder and Allied Disorders
- Spinal Cord Injuries
- Interventions
- Biological: Autologous micro-fragmented adipose tissue
- Device: Lipogems system
- Sponsor
- Kessler Foundation
- Start date
- 2017-07-14
- Primary completion
- 2019-09-06
- Sex
- All
- Age range
- from 18 Years to 70 Years
- Results posted
- No results posted in this snapshot
- Countries
- United States
- Total sites listed
- 1
Eligibility criteria
Show eligibility criteria (verbatim from the registry)
Inclusion Criteria: * The subject is male or female, 18 to 60 years of age, inclusive. * The subject has neurological impairment secondary to a spinal cord injury that occurred at least twelve (12) months prior to the Screening Visit and the level of the injury is between C5 and L5, inclusive. * The subject is non-ambulatory except for exercise purposes and uses a manual or power wheelchair as his/her primary means of mobility (\> 40 hours/week). * The subject currently has chronic shoulder pain due to rotator cuff disease in spite of at least 6 months of conservative treatment (Note: 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). * The average shoulder pain intensity during the week leading up to the Screening Visit should be at least 4 out of 10 on an 11-point numerical rating scale (NRS; 0, no pain; 10, maximum pain imaginable). * The subject is able and willing to comply with the protocol. * The subject is able to and has voluntarily given informed consent prior to the performance of any study-specific procedures. Exclusion Criteria: * The subject reports prior Lipogems treatment in the same shoulder. * The subject reports a history of systemic disorders, such as diabetes or rheumatoid arthritis. * The subject has contra-indications to the procedure, such as infection, coagulopathy, or is currently taking anti-coagulants. * The subject reports having a glucocorticoid injection in the past 4 weeks. * The subject is pregnant (documented by a urine pregnancy test). * The subject has any medical condition, including psychiatric disease, which would interfere with the interpretation of the study results or the conduct of the study.
Source: ClinicalTrials.gov (US National Library of Medicine), snapshot October 2026. Check the registry for current recruiting status. Record: https://clinicaltrials.gov/study/NCT03167138