Ultrasound-Guided Treatments for Shoulder Pain in Wheelchair Users With Spinal Cord Injury
MFAT-SCI
1 other identifier
interventional
24
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for phase_2
Started Jun 2019
Longer than P75 for phase_2
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
June 14, 2019
CompletedFirst Submitted
Initial submission to the registry
July 1, 2019
CompletedFirst Posted
Study publicly available on registry
October 23, 2019
CompletedPrimary Completion
Last participant's last visit for primary outcome
April 30, 2023
CompletedStudy Completion
Last participant's last visit for all outcomes
April 30, 2024
CompletedOctober 14, 2022
October 1, 2022
3.9 years
July 1, 2019
October 12, 2022
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Change in Numerical Rating Scale
Shoulder pain intensity will be assessed using an 11-point numerical rating scale (NRS; 0-10, ranging from 0 = "no pain" to a maximum of 10= "pain as bad as you can imagine". Pain intensity is the most common pain domain assessed in research and clinical settings. Although different rating scales have proven to be valid for assessing pain intensity, the 11-point NRS has the most strengths and fewest weaknesses of available measures. An 11-point NRS measure of pain intensity allows for comparison across clinical trials of chronic pain treatment and has been recommended by the IMMPACT consensus group for use in pain clinical trials and by the 2006 NIDRR SCI Pain outcome measures consensus group. We will evaluate changes in scores between baseline and 6 months.
6 months
Secondary Outcomes (5)
Wheelchair User's Shoulder Pain Index
6 months
Patient Global Impression of Change
6 months
Physical Examination of the Shoulder Scale
6 months
Ultrasound Shoulder Pathology Rating Scale
6 months
Quantitative Ultrasound of the Supraspinatus Tendon
6 months
Study Arms (2)
Corticosteroid
ACTIVE COMPARATORParticipants 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.
Micro-Fragmented Adipose Tissue
EXPERIMENTALParticipants 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
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.
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.
Eligibility Criteria
You may qualify if:
- 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.
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Kessler Foundation
West Orange, New Jersey, 07052, United States
Related Publications (2)
Cherian C, Malanga GA, Hogaboom N, Pollack MA, Dyson-Hudson TA. Autologous, micro-fragmented adipose tissue as a treatment for chronic shoulder pain in a wheelchair using individual with spinal cord injury: a case report. Spinal Cord Ser Cases. 2019 May 13;5:46. doi: 10.1038/s41394-019-0186-8. eCollection 2019.
PMID: 31632705BACKGROUNDRandelli P, Menon A, Ragone V, Creo P, Bergante S, Randelli F, De Girolamo L, Alfieri Montrasio U, Banfi G, Cabitza P, Tettamanti G, Anastasia L. Lipogems Product Treatment Increases the Proliferation Rate of Human Tendon Stem Cells without Affecting Their Stemness and Differentiation Capability. Stem Cells Int. 2016;2016:4373410. doi: 10.1155/2016/4373410. Epub 2016 Jan 6.
PMID: 27057170BACKGROUND
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- RANDOMIZED
- Masking
- SINGLE
- Who Masked
- OUTCOMES ASSESSOR
- Masking Details
- The assessor will be blinded to treatment group when analyzing data for publication.
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
July 1, 2019
First Posted
October 23, 2019
Study Start
June 14, 2019
Primary Completion
April 30, 2023
Study Completion
April 30, 2024
Last Updated
October 14, 2022
Record last verified: 2022-10