Status:
UNKNOWN
Ultrasound-Guided Treatments for Shoulder Pain in Wheelchair Users With Spinal Cord Injury
Lead Sponsor:
Kessler Foundation
Conditions:
Spinal Cord Injuries
Tendinopathy
Eligibility:
All Genders
18-70 years
Phase:
PHASE2
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 su...
Detailed 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 ...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
June 14 2019
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
April 30 2024
Estimated Enrollment :
24 Patients enrolled
Trial Details
Trial ID
NCT04136743
Start Date
June 14 2019
End Date
April 30 2024
Last Update
October 14 2022
Active Locations (1)
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1
Kessler Foundation
West Orange, New Jersey, United States, 07052