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

Phase

Condition

Tendon Injuries

Sprains

Spinal Cord Injuries

Treatment

N/A

Clinical Study ID

NCT04136743

R-1066-19

Ages 18-70
All Genders

Study 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.

Eligibility Criteria

Inclusion

Inclusion Criteria:

Men and women, 18 to 70 years of age, inclusive
Neurological impairment secondary to a spinal cord injury or disorder that occurred atleast twelve (12) months prior to the Screening Visit and the level of the injury isbetween C6 and L5, inclusive
Non-ambulatory except for exercise purposes and uses a manual or power wheelchair ashis/her primary means of mobility (> 40 hours/week)
Currently has chronic shoulder pain due to rotator cuff disease in spite of at least 6months of conservative treatment
Average shoulder pain intensity during the week leading up to the Screening Visit isat 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 directpalpation and pain at the shoulder with provocative tests for rotator cuff diseasethat is confirmed by tendinopathic changes on ultrasound imaging.

Exclusion

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, orcurrently 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 withthe interpretation of the study results or the conduct of the study

Study Design

June 14, 2019

April 30, 2024

Study Description

This is randomized controlled trial to determine the efficacy of autologous, micro-fragmented adipose tissue (MFAT) injection under ultrasound guidance for chronic, nonresponsive shoulder pain due to rotator cuff disease (i.e., rotator cuff tendinopathy) in persons with spinal cord injury (SCI). The control for this study, to which MFAT will be compared, is corticosteroid injection into the subacromial space. Twenty-four (24) persons with SCI who have chronic shoulder pain for longer than 6 months in spite of completing conservative treatment and who are diagnosed with rotator cuff disease on examination will be recruited.

MFAT Group: Micro-fragmented adipose tissue will be obtained by using a minimal manipulation technique in a closed system (Lipogems®), without the addition of enzymes or any additives. The final product will consist of micronized fat tissue yielding fat clusters with preserved vascular stroma of about 500 microns with intact stromal vascular niches and harboring regenerative cellular elements. Approximately 6 mL of micro-fragmented adipose will be injected into the tendon with a 22-gauge needle under continuous ultrasound guidance. No other biological or pharmacological agents will be used in combination with the micro-fragmented adipose.

Corticosteroid Group: In the corticosteroid group, 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.

Both Groups: After 24 hours, participants will be given a standardized stretching protocol to follow for 4 weeks followed by a formal strengthening program. Participants will be followed for adverse events and changes in shoulder pain intensity on an 11-point numerical rating scale (NRS; 0-10, with anchors "no pain" and "pain as bad as you can imagine"); the Wheelchair User's Shoulder Pain Index (WUSPI; 15-item disease-specific functional measure of shoulder pain in persons with SCI); the PROMIS Physical Functioning short form; the Brief Pain Inventory interference items (BPI-I7; a subscale of 7 items measuring interference with general activity, sleep, mood, relationships, etc.); and a 5-point subject global impression of change (SGIC) scale. Subjects will be examined at 1 month, 2 months, 3 months, and 6 months after the treatment. In addition to subjective outcome measures, quantitative ultrasounds will be conducted at baseline, 1 month, 2 months, 3 months, and 6 months post-treatment.

Connect with a study center

Kessler Foundation
West Orange, New Jersey 07052
United States
Active - Recruiting

Not the study for you?

Let us help you find the best match. Sign up as a volunteer and receive email notifications when clinical trials are posted in the medical category of interest to you.