- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03167138
Micro-Fragmented Adipose Tissue (Lipogems®) Injection for Chronic Shoulder Pain in Persons With Spinal Cord Injury
February 12, 2020 updated by: Trevor Dyson-Hudson, M.D., Kessler Foundation
Treatment of Chronic Shoulder Pain in Persons With Spinal Cord Injury Using Injection With Autologous Micro-Fragmented Adipose Tissue Under Ultrasound Guidance
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.
Study Overview
Status
Unknown
Conditions
Intervention / Treatment
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.
Study Type
Interventional
Enrollment (Actual)
10
Phase
- Early Phase 1
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
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New Jersey
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West Orange, New Jersey, United States, 07052
- Kessler Institute for Rehabilitation
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Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years to 70 years (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
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.
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Autologous micro-fragmented adipose tissue
Injection (under ultrasound guidance) of autologous micro-fragmented adipose tissue obtained from abdominal region or thighs using the Lipogems® system.
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Micro-fragmented adipose tissue is obtained from abdominal region or thighs using the Lipogems® system and injected into the injury site under ultrasound guidance.
Other Names:
The Lipogems® system is a non-enzymatic method to obtain micro-fragmented adipose tissue from the abdominal region or thighs for injection into the injury site.
Other Names:
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Numerical Rating Scale
Time Frame: Baseline and 4 weeks, 8 weeks, 12 weeks, and 24 weeks after the treatment.
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Shoulder pain intensity will also be assessed weekly using a numerical rating scale (NRS).
Subjects will be asked to rate their average pain, most severe pain, and least severe pain during the past week using an 11-point scale (i.e.
0-10) anchored at the ends by "no pain" and "pain as bad as you can imagine."
An 11-point NRS measure of pain intensity allows for comparison across clinical trials of chronic pain treatment and is recommended as a core outcome measure for chronic pain clinical trials.
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Baseline and 4 weeks, 8 weeks, 12 weeks, and 24 weeks after the treatment.
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Wheelchair User's Shoulder Pain Index (WUSPI)
Time Frame: Baseline and 4 weeks, 8 weeks, 12 weeks, and 24 weeks after the treatment.
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The WUSPI is a 15-item self-report instrument that measures shoulder pain intensity in wheelchair users during various ADLs, such as transfers, loading a wheelchair into a car, wheelchair mobility, dressing, bathing, overhead lifting, driving, performing household chores, and sleeping.
Each item is scored using a 10cm visual analog scale (VAS) which is anchored at the ends with "no pain" and "worst pain ever experienced."
Individual item scores are summed to arrive at a total index score, which ranges from 0 to 150.
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Baseline and 4 weeks, 8 weeks, 12 weeks, and 24 weeks after the treatment.
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Patient Global Impression of Change
Time Frame: Baseline and 4 weeks, 8 weeks, 12 weeks, and 24 weeks after the treatment.
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Subjects will be asked to rate on a 7-point scale overall impression following treatment as compared to the previous measurement interval.
The 7-point PGIC scale (anchored by "very much improved" and "very much worse") is used to measure global treatment effect.
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Baseline and 4 weeks, 8 weeks, 12 weeks, and 24 weeks after the treatment.
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Brief Pain Inventory interference items (BPI-I7)
Time Frame: Baseline and 4 weeks, 8 weeks, 12 weeks, and 24 weeks after the treatment.
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The Brief Pain Inventory (BPI) was developed by Cleeland, and has been used in a number of investigations of chronic pain.
Its pain interference subscale has been used in several investigations of pain in SCI.
In its original version the subscale (BPI-I7) consisted of 7 items measuring interference with general activity, sleep, mood, relationships, etc.).
For uses with an SCI sample, in item 3 of BPI-I7, ''walking ability'' is replaced by "ability to get around."
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Baseline and 4 weeks, 8 weeks, 12 weeks, and 24 weeks after the treatment.
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Physical Examination of the Shoulder Score (PESS)
Time Frame: Baseline and 4 weeks, 8 weeks, 12 weeks, and 24 weeks after the treatment.
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The Physical Examination of the Shoulder Score (PESS) is obtained by performing a series of eleven commonly used physical examination maneuvers for rotator cuff disease and shoulder pain that are graded 0 (no pain), 1 (equivocal for pain), or 2 (pain present).
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Baseline and 4 weeks, 8 weeks, 12 weeks, and 24 weeks after the treatment.
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Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Principal Investigator: Trevor A. Dyson-Hudson, M.D., Kessler Foundation
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
July 14, 2017
Primary Completion (Actual)
September 6, 2019
Study Completion (Anticipated)
February 21, 2020
Study Registration Dates
First Submitted
May 24, 2017
First Submitted That Met QC Criteria
May 24, 2017
First Posted (Actual)
May 25, 2017
Study Record Updates
Last Update Posted (Actual)
February 17, 2020
Last Update Submitted That Met QC Criteria
February 12, 2020
Last Verified
February 1, 2020
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
- Pathologic Processes
- Central Nervous System Diseases
- Nervous System Diseases
- Pain
- Neurologic Manifestations
- Disease
- Joint Diseases
- Musculoskeletal Diseases
- Muscular Diseases
- Rupture
- Shoulder Injuries
- Tendon Injuries
- Trauma, Nervous System
- Spinal Cord Diseases
- Arthralgia
- Syndrome
- Rotator Cuff Injuries
- Tendinopathy
- Wounds and Injuries
- Shoulder Impingement Syndrome
- Shoulder Pain
- Spinal Cord Injuries
Other Study ID Numbers
- R-957-17
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
No
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
Yes
product manufactured in and exported from the U.S.
Yes
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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