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: : ClinicalTrials.gov identifier: NCT03167138.