Clinical trial NCT03167138: Micro-Fragmented Adipose Tissue (Lipogems®) Injection for Chronic Shoulder Pain in Persons With Spinal Cord Injury
Official title: Treatment of Chronic Shoulder Pain in Persons With Spinal Cord Injury Using Injection With Autologous Micro-Fragmented Adipose Tissue Under Ultrasound Guidance
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: EARLY_PHASE1
Conditions: Shoulder Pain
Shoulder Impingement Syndrome
Rotator Cuff Impingement Syndrome
Rotator Cuff Tendinitis
Rotator Cuff Syndrome of Shoulder and Allied Disorders
Spinal Cord Injuries
Keywords: Shoulder pain
Rotator cuff disease
Spinal cord injuries
Mesenchymal stromal cells
Regenerative medicine
Rehabilitation
Lead sponsor: Kessler Foundation
Sponsor class: OTHER
First posted: 2017-05-25
Enrollment: 10
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention model description: Single Group Assignment
Primary purpose: TREATMENT

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. 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.

Detailed description: This is an exploratory pilot study to determine the safety and efficacy of autologous, micro-fragmented adipose tissue (Lipogems®) 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). Twelve (12) persons with SCI who have chronic shoulder pain for longer than 6 months in spite of completing conservative treatment who are diagnosed with rotator cuff disease on examination. 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. After 24 hours, subjects 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 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. Follow-up shoulder ultrasound will be performed at 6 months.

Eligibility criteria: 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.

Primary outcomes:
measure: Numerical Rating Scale
timeFrame: Baseline and 4 weeks, 8 weeks, 12 weeks, and 24 weeks after the treatment.
Secondary outcomes:
measure: Wheelchair User's Shoulder Pain Index (WUSPI)
timeFrame: Baseline and 4 weeks, 8 weeks, 12 weeks, and 24 weeks after the treatment.
measure: Patient Global Impression of Change
timeFrame: Baseline and 4 weeks, 8 weeks, 12 weeks, and 24 weeks after the treatment.
measure: Brief Pain Inventory interference items (BPI-I7)
timeFrame: Baseline and 4 weeks, 8 weeks, 12 weeks, and 24 weeks after the treatment.
measure: Physical Examination of the Shoulder Score (PESS)
timeFrame: Baseline and 4 weeks, 8 weeks, 12 weeks, and 24 weeks after the treatment.
Other outcomes:
Locations:
city: West Orange
country: United States
facility: Kessler Institute for Rehabilitation
state: New Jersey
Study officials:
affiliation: Kessler Foundation
name: Trevor A. Dyson-Hudson, M.D.
role: PRINCIPAL_INVESTIGATOR
References:
citation: Hogaboom N, Malanga G, Cherian C, Dyson-Hudson T. A pilot study to evaluate micro-fragmented adipose tissue injection under ultrasound guidance for the treatment of refractory rotator cuff disease in wheelchair users with spinal cord injury. J Spinal Cord Med. 2021 Nov;44(6):886-895. doi: 10.1080/10790268.2021.1903140. Epub 2021 Apr 8.