Nathan Hogaboom1,2, Gerard Malanga2,3,4, Chris Cherian2, Trevor Dyson-Hudson1,2. 1. Kessler Foundation, West Orange, New Jersey, USA. 2. Department of Physical Medicine and Rehabilitation, Rutgers New Jersey Medical School, Newark, New Jersey, USA. 3. New Jersey Regenerative Institute, Cedar Knolls, New Jersey, USA. 4. Kessler Institute for Rehabilitation, West Orange, New Jersey, USA.
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.
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.
Authors: Chris H Jo; Jee Won Chai; Eui Cheol Jeong; Sohee Oh; Paul S Kim; Jeong Yong Yoon; Kang Sup Yoon Journal: Stem Cells Date: 2018-07-16 Impact factor: 6.277
Authors: Steven W Brose; Michael L Boninger; Bradley Fullerton; Thane McCann; Jennifer L Collinger; Bradley G Impink; Trevor A Dyson-Hudson Journal: Arch Phys Med Rehabil Date: 2008-11 Impact factor: 3.966