Recruiting
Phase 2

Ultrasound-Guided Treatments

Sponsor:

Kessler Foundation

Code:

NCT04136743

Conditions

Spinal Cord Injuries

Tendinopathy

Rotator Cuff Tears

Shoulder Pain

Eligibility Criteria

Sex: All

Age: 18 - 70

Healthy Volunteers: Not accepted

Interventions

Lipogems

Dexamethasone

Study Details

Brief 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.

Conditions

Spinal Cord Injuries

Tendinopathy

Rotator Cuff Tears

Shoulder Pain

Study ID

NCT04136743

Start date

Jun 14, 2019

Status verified date

Oct, 2022

Completion date

Apr 30, 2024

Anticipated

Primary completion date

Apr 30, 2023

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18 - 70

Healthy Volunteers: Not accepted

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

Study Design

Enrollment

24 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

active comparator: Corticosteroid

Participants will receive a corticosteroid injection (BMS, Kenacort-A 40 mg \[triamcinolone acetonide\]) into the subacromial space under direct ultrasound guidance by means of a 5-mL syringe with a 22-guage needle.

experimental: Micro-Fragmented Adipose Tissue

Participants will receive a single injection of micro-fragmented adipose tissue into the lesion (e.g. tear, subacromial bursa, glenohumeral joint, acromioclavicular joint) under ultrasound guidance using an 18 gauge x 3.5 inch needle.

Interventions

Lipogems

The Lipogems system (Lipogems International SpA, Milan, Italy) is designed to isolate autologous, micro-fragmented adipose tissue without enzymes or other additives. It uses mild mechanical forces to break down adipose tissue that is extracted from the patient into a form that can be injected into the tendon lesion and other degenerated tissues in a sterile and safe manner. The resulting product is rich in pericytes and mesenchymal stromal cells, retained within an intact stromal vascular niche, that is ready for use in clinical applications.

Dexamethasone

Triamcinolone Acetonide is a corticosteroid, which is a class of drugs that are commonly prescribed for shoulder pain. They work to reduce pain by limiting inflammation. They are typically injected into the subacromial space with or without ultrasound guidance.

Primary outcome measure

  • Change in Numerical Rating Scale [ Time Frame: 6 months ]

Central Contacts and Locations

Central contacts

Trevor A Dyson-Hudson, MD

973-324-3576tdysonhudson@kesslerfoundation.org

Gerard A Malanga, MD

973-998-8301gmalangamd@hotmail.com

Locations

Kessler Foundation

Recruiting

West Orange, New Jersey, United States, 07052

Contacts

Trevor A Dyson-Hudson, MD

973-324-3576tdysonhudson@kesslerfoundation.org

Matthew Weiner

973-324-3515mweiner@kesslerfoundation.org

Principal Investigator:

Trevor A Dyson-Hudson, MD

More Information

Sponsor

Kessler Foundation

Last update posted

Oct 14, 2022

Last verified

Oct, 2022

Keywords

  • Rehabilitation
  • Regenerative Medicine
  • Regenerative Rehabilitation

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Kessler Foundation on 2022-10-14.