Micro-Fragmented Adipose Tissue (Lipogems®) Injection for Chronic Shoulder Pain in Persons With Spinal Cord Injury
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|ClinicalTrials.gov Identifier: NCT03167138|
Recruitment Status : Recruiting
First Posted : May 25, 2017
Last Update Posted : August 8, 2018
|Condition or disease||Intervention/treatment||Phase|
|Shoulder Pain Shoulder Impingement Syndrome Rotator Cuff Impingement Syndrome Rotator Cuff Tendinitis Rotator Cuff Syndrome of Shoulder and Allied Disorders Spinal Cord Injuries||Biological: Autologous micro-fragmented adipose tissue Device: Lipogems system||Early Phase 1|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||12 participants|
|Intervention Model:||Single Group Assignment|
|Intervention Model Description:||Single Group Assignment|
|Masking:||None (Open Label)|
|Masking Description:||No masking|
|Official Title:||Treatment of Chronic Shoulder Pain in Persons With Spinal Cord Injury Using Injection With Autologous Micro-Fragmented Adipose Tissue Under Ultrasound Guidance|
|Actual Study Start Date :||July 14, 2017|
|Estimated Primary Completion Date :||December 30, 2019|
|Estimated Study Completion Date :||December 30, 2019|
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.
Biological: Autologous micro-fragmented adipose tissue
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 Name: Lipogems
Device: Lipogems system
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 Name: Lipogems technological process
- Numerical Rating Scale [ Time Frame: Baseline and 4 weeks, 8 weeks, 12 weeks, and 24 weeks after the treatment. ]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.
- Wheelchair User's Shoulder Pain Index (WUSPI) [ Time Frame: Baseline and 4 weeks, 8 weeks, 12 weeks, and 24 weeks after the treatment. ]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.
- Patient Global Impression of Change [ Time Frame: Baseline and 4 weeks, 8 weeks, 12 weeks, and 24 weeks after the treatment. ]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.
- Brief Pain Inventory interference items (BPI-I7) [ Time Frame: Baseline and 4 weeks, 8 weeks, 12 weeks, and 24 weeks after the treatment. ]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."
- Physical Examination of the Shoulder Score (PESS) [ Time Frame: Baseline and 4 weeks, 8 weeks, 12 weeks, and 24 weeks after the treatment. ]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).
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03167138
|Contact: Trevor A. Dyson-Hudson, M.D.||email@example.com|
|Contact: Gerard A. Malanga, M.D.||firstname.lastname@example.org|
|United States, New Jersey|
|Kessler Institute for Rehabilitation||Recruiting|
|West Orange, New Jersey, United States, 07052|
|Contact: Trevor A. Dyson-Hudson, M.D. 973-324-3576 email@example.com|
|Contact: Matthew Weiner 973-324-3515 firstname.lastname@example.org|
|Principal Investigator: Gerard A. Malanga, M.D.|
|Sub-Investigator: Steven C. Kirshblum, M.D.|
|Sub-Investigator: Chris Cherian, M.D.|
|Sub-Investigator: Reina Nakamura, M.D.|
|Principal Investigator:||Trevor A. Dyson-Hudson, M.D.||Kessler Foundation|