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.

Keywords: Clinical Trials; Rehabilitation; Rotator cuff injuries; Shoulder pain; Spinal cord injuries; Wheelchairs; regenerative medicine.

Figure 1

Change in numerical pain rating scale (NRS) scores at each timepoint over the 24-week course of the trial. Scores declined steadily over the first 3 months, with minimal observed changes between 3 and 12 months. Dotted lines indicate individual scores. The solid black line indicates mean scores.

Figure 2

Change in Wheelchair User’s Shoulder Pain Index (WUSPI) scores at each timepoint over the 12-month course of the trial. Scores declined steadily over the first 3 months, with minimal observed changes between 3 and 12 months. Dotted lines indicate individual scores. The solid black line indicates mean scores.

Figure 3

Changes in Brief Pain Inventory pain interference (BPI-I7) scores at each timepoint over the 12-month course of the trial. Scores declined steadily over the entire year. Dotted lines indicate individual scores. The solid black line indicates mean scores.