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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.


ABSTRACT:

Context/objectives

Wheelchair users with chronic shoulder pain have few options after conservative treatments fail. This pilot study's purpose was to establish safety and treatment effects of micro-fragmented adipose tissue (MFAT) injections under ultrasound guidance for treatment of refractory shoulder pain caused by rotator cuff disease in wheelchair users with spinal cord injury (SCI) to prepare for a larger trial.

Design

Pilot clinical trial.

Setting

Rehabilitation hospital outpatient clinic.

Participants

Ten wheelchair users with chronic SCI who had moderate-to-severe shoulder pain caused by refractory rotator cuff disease (diagnosed via ultrasound) for greater than 6 months.

Interventions

Ultrasound-guided injections of MFAT into the pathologic rotator cuff tendons and other abnormal shoulder structures (e.g. acromioclavicular and glenohumeral joints; subacromial bursa).

Outcome measures

6- and 12-month changes in 11-point Numerical Rating Scale (NRS); Wheelchair User's Shoulder Pain Index (WUSPI); Brief Pain Inventory pain interference items (BPI-I7); Patient Global Impression of Change (PGIC); ultrasound and physical exams; and adverse events.

Conclusions

There were no significant adverse events throughout the study period. WUSPI, NRS, and BPI-I7 scores were significantly lower 6 and 12 months post-procedure (P < .05). Of those who remained in the trial, clinically meaningful changes (≥30% decrease) in WUSPI, NRS, and BPI-I7 scores were observed in 77.8%, 77.8%, and 66.7% of participants, respectively. All but one participant reported improvement in clinical status. MFAT injection under ultrasound guidance is potentially a safe and efficacious treatment for refractory shoulder pain caused by rotator cuff disease in wheelchair users with SCI. A larger, randomized controlled trial has been initiated.Trial registration: ClinicalTrials.gov identifier: NCT03167138.

SUBMITTER: Hogaboom N 

PROVIDER: S-EPMC8725703 | biostudies-literature | 2021 Nov

REPOSITORIES: biostudies-literature

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Publications

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.

Hogaboom Nathan N   Malanga Gerard G   Cherian Chris C   Dyson-Hudson Trevor T  

The journal of spinal cord medicine 20210408 6


<h4>Context/objectives</h4>Wheelchair users with chronic shoulder pain have few options after conservative treatments fail. This pilot study's purpose was to establish safety and treatment effects of micro-fragmented adipose tissue (MFAT) injections under ultrasound guidance for treatment of refractory shoulder pain caused by rotator cuff disease in wheelchair users with spinal cord injury (SCI) to prepare for a larger trial.<h4>Design</h4>Pilot clinical trial.<h4>Setting</h4>Rehabilitation hosp  ...[more]

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