Micro-Fragmented Adipose Tissue (Lipogems®) Injection for Chronic Shoulder Pain in Persons With Spinal Cord Injury

NCT03167138 | Unknown Early Phase 1 FDA Device

• 1 other identifier: R-957-17
• Study Type: interventional
• Target: 10
• Locations: 1 country
• Sites: 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. 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.

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

Outcome Measures

Primary Outcomes (1)

• Numerical Rating Scale

  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.

  Baseline and 4 weeks, 8 weeks, 12 weeks, and 24 weeks after the treatment.

Secondary Outcomes (4)

• Wheelchair User's Shoulder Pain Index (WUSPI)

  Baseline and 4 weeks, 8 weeks, 12 weeks, and 24 weeks after the treatment.

• Patient Global Impression of Change

  Baseline and 4 weeks, 8 weeks, 12 weeks, and 24 weeks after the treatment.

• Brief Pain Inventory interference items (BPI-I7)

  Baseline and 4 weeks, 8 weeks, 12 weeks, and 24 weeks after the treatment.

• Physical Examination of the Shoulder Score (PESS)

  Baseline and 4 weeks, 8 weeks, 12 weeks, and 24 weeks after the treatment.

Study Arms (1)

Autologous micro-fragmented adipose tissue

EXPERIMENTAL

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; Device: Lipogems system

Interventions

Autologous micro-fragmented adipose tissue BIOLOGICAL

Micro-fragmented adipose tissue is obtained from abdominal region or thighs using the Lipogems® system and injected into the injury site under ultrasound guidance.

Also known as: Lipogems

Autologous micro-fragmented adipose tissue

Lipogems system DEVICE

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.

Also known as: Lipogems technological process

Autologous micro-fragmented adipose tissue

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Kessler Foundation: lead

Study Sites (1)

Kessler Institute for Rehabilitation

West Orange, New Jersey, 07052, United States

Location

Related Publications (1)

• 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.

  PMID: 33830898 DERIVED

MeSH Terms

Conditions

Shoulder Pain; Shoulder Impingement Syndrome; Rotator Cuff Injuries; Spinal Cord Injuries

Condition Hierarchy (Ancestors)

Arthralgia; Joint Diseases; Musculoskeletal Diseases; Pain; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Shoulder Injuries; Wounds and Injuries; Rupture; Tendon Injuries; Spinal Cord Diseases; Central Nervous System Diseases; Nervous System Diseases; Trauma, Nervous System

Study Officials

• Trevor A. Dyson-Hudson, M.D.

  Kessler Foundation

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: early phase 1
• Allocation: NA
• Masking: NONE
• Masking Details: No masking
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Director, Spinal Cord Injury Research

Model Details: Single Group Assignment

Study Record Dates

• First Submitted: May 24, 2017
• First Posted: May 25, 2017
• Study Start: July 14, 2017
• Primary Completion: September 6, 2019
• Study Completion: February 21, 2020
• Last Updated: February 17, 2020

Record last verified: 2020-02

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)