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Ultrasound-Guided Treatments for Shoulder Pain in Wheelchair Users With Spinal Cord Injury (MFAT-SCI)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04136743
Recruitment Status : Unknown
Verified February 2020 by Kessler Foundation.
Recruitment status was:  Recruiting
First Posted : October 23, 2019
Last Update Posted : February 18, 2020
Sponsor:
Information provided by (Responsible Party):
Kessler Foundation

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.

Condition or disease Intervention/treatment Phase
Spinal Cord Injuries Tendinopathy Rotator Cuff Tears Shoulder Pain Device: Lipogems Drug: Dexamethasone Phase 2

Detailed Description:

This is randomized controlled trial to determine the efficacy of autologous, micro-fragmented adipose tissue (MFAT) 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). The control for this study, to which MFAT will be compared, is corticosteroid injection into the subacromial space. Twenty-four (24) persons with SCI who have chronic shoulder pain for longer than 6 months in spite of completing conservative treatment and who are diagnosed with rotator cuff disease on examination will be recruited.

MFAT Group: 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.

Corticosteroid Group: In the corticosteroid group, participants 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.

Both Groups: After 24 hours, participants 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 PROMIS Physical Functioning short form; 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. In addition to subjective outcome measures, quantitative ultrasounds will be conducted at baseline, 1 month, 2 months, 3 months, and 6 months post-treatment.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 24 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Masking Description: The assessor will be blinded to treatment group when analyzing data for publication.
Primary Purpose: Treatment
Official Title: Ultrasound-Guided Treatments for Chronic Shoulder Pain in Wheelchair Users With Spinal Cord Injury: A Randomized Controlled Trial
Actual Study Start Date : June 14, 2019
Estimated Primary Completion Date : April 30, 2022
Estimated Study Completion Date : April 30, 2022

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Active Comparator: Corticosteroid
Participants 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.
Drug: Dexamethasone
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.
Other Name: Corticosteroid

Experimental: Micro-Fragmented Adipose Tissue
Participants 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.
Device: Lipogems
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.
Other Name: Micro-fragmented Adipose Tissue




Primary Outcome Measures :
  1. Change in Numerical Rating Scale [ Time Frame: 6 months ]
    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.


Secondary Outcome Measures :
  1. Wheelchair User's Shoulder Pain Index [ Time Frame: 6 months ]
    Activity-dependent shoulder pain intensity will be assessed using the Wheelchair Users Shoulder Pain Index (WUSPI). The WUSPI is a 15-item self-report instrument that measures shoulder pain intensity in wheelchair users during various ADLs over the past week; for example, 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. We will evaluate changes in scores between baseline and 6 months.

  2. Patient Global Impression of Change [ Time Frame: 6 months ]
    The subject will be asked to rate on a 7-point scale his or her overall impression following treatment as compared to the previous measurement interval. The 7-point PGIC scale (also referred to as the original Guy/Farrar-PGIC scale; anchored by "very much improved" and "very much worse") is used to measure global treatment effect and is recommended as a compliment to unidimensional pain intensity scales. Although other versions of the PGIC scale exist, the SCI Measures Pain Committee recommends using the original Guy/Farrar-PGIC scale in clinical trials since it has been used extensively and been shown to be sensitive to change. We will evaluate scores at 6 months.

  3. Physical Examination of the Shoulder Scale [ Time Frame: 6 months ]
    The PESS will be derived from findings during the shoulder examination performed. The PESS was developed to apply a grading system to commonly-used provocative tests for the diagnosis of shoulder soft-tissue disorders. Eleven physical examination maneuvers are given a score dependent upon the pain elicited: 0 (no pain), 1 (equivocal for pain), or 2 (pain present). The scores are summed for a total between 0 and 22. The physical examination maneuvers include: biceps tendon/bicipital groove tenderness; supraspinatus tendon/greater tuberosity tenderness; acromioclavicular joint tenderness; resisted external rotation; resisted internal rotation; supraspinatus test; painful arc test; Neer impingement sign; Hawkins-Kennedy impingement sign; O'Brien active compression test for acromioclavicular joint and labral pathology. We will evaluate changes in scores between baseline and 6 months.

  4. Ultrasound Shoulder Pathology Rating Scale [ Time Frame: 6 months ]
    All participants will undergo a clinical ultrasound examination. The ultrasound will be performed by a physiatrist with musculoskeletal ultrasound training. The Ultrasound Shoulder Pathology Rating Scale (USPRS) applies a grade to seven ultrasound findings for shoulder pathology. The scale is designed to give an impression of global shoulder pathology associated with overuse. A score of 0 indicates no observable pathology, up to a maximum of 23. The exams include biceps tendinosis/tendinopathy; supraspinatus tendinosis/tendinopathy; greater tuberosity cortical surface irregularities; bursal thickening; joint edema; dynamic supraspinatus and subscapularis impingement. We will evaluate changes in scores between baseline and 6 months.

  5. Quantitative Ultrasound of the Supraspinatus Tendon [ Time Frame: 6 months ]
    Quantitative ultrasound protocols will be used to evaluate changes in morphological and structural characteristics of the supraspinatus tendon after treatment. We will collect conventional B-mode ultrasound images alongside shear wave elastography images and apply custom image analysis algorithms to quantify the parameters of interest. Greyscale parameters of interest include tendon thickness and mean echogenicity (i.e. "brightness"), which are reflective of inflammation and edema. This method will be adapted based on a previously-validated technique that has been used in wheelchair users with SCI. The primary elastography parameter of interest is strain ratio; that is, the strain within the ROI relative to a reference point in the deltoid muscle immediately outside the tendon. We will evaluate changes in greyscale and shear wave parameters between baseline and 6 months.



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Ages Eligible for Study:   18 Years to 70 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • 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.

Exclusion Criteria:

  • 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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04136743


Contacts
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Contact: Trevor A Dyson-Hudson, MD 973-324-3576 tdysonhudson@kesslerfoundation.org
Contact: Gerard A Malanga, MD 973-998-8301 gmalangamd@hotmail.com

Locations
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United States, New Jersey
Kessler Foundation Recruiting
West Orange, New Jersey, United States, 07052
Contact: Trevor A Dyson-Hudson, MD    973-324-3576    tdysonhudson@kesslerfoundation.org   
Contact: Matthew Weiner    973-324-3515    mweiner@kesslerfoundation.org   
Principal Investigator: Trevor A Dyson-Hudson, MD         
Sub-Investigator: Gerard A Malanga, MD         
Sub-Investigator: Nathan S Hogaboom, PhD         
Sponsors and Collaborators
Kessler Foundation
Publications:
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Responsible Party: Kessler Foundation
ClinicalTrials.gov Identifier: NCT04136743    
Other Study ID Numbers: R-1066-19
First Posted: October 23, 2019    Key Record Dates
Last Update Posted: February 18, 2020
Last Verified: February 2020

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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
Keywords provided by Kessler Foundation:
Rehabilitation
Regenerative Medicine
Regenerative Rehabilitation
Additional relevant MeSH terms:
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Shoulder Pain
Tendinopathy
Spinal Cord Injuries
Wounds and Injuries
Rotator Cuff Injuries
Spinal Cord Diseases
Central Nervous System Diseases
Nervous System Diseases
Trauma, Nervous System
Arthralgia
Joint Diseases
Musculoskeletal Diseases
Pain
Neurologic Manifestations
Rupture
Shoulder Injuries
Tendon Injuries
Muscular Diseases
Dexamethasone
Anti-Inflammatory Agents
Antiemetics
Autonomic Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Gastrointestinal Agents
Glucocorticoids
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists
Antineoplastic Agents, Hormonal
Antineoplastic Agents