Helene Bertrand1, Kenneth Dean Reeves2, Cameron J Bennett3, Simon Bicknell4, An-Lin Cheng5. 1. Department of Family Practice, School of Medicine, University of British Columbia, Vancouver, British Columbia, Canada. 2. Department of Physical Medicine and Rehabilitation, University of Kansas, Kansas City, KS. Electronic address: DeanReevesMD@gmail.com. 3. Private Practice, West Vancouver, British Columbia, Canada. 4. Department of Radiology, University of British Columbia, Vancouver, British Columbia, Canada. 5. School of Nursing and Health Studies, University of Missouri-Kansas City, Kansas City, MO.
Abstract
OBJECTIVE: To compare the effect of dextrose prolotherapy on pain levels and degenerative changes in painful rotator cuff tendinopathy against 2 potentially active control injection procedures. DESIGN: Randomized controlled trial, blinded to participants and evaluators. SETTING:Outpatient pain medicine practice. PARTICIPANTS: Persons (N=73) with chronic shoulder pain, examination findings of rotator cuff tendinopathy, and ultrasound-confirmed supraspinatus tendinosis/tear. INTERVENTIONS: Three monthly injections either (1) onto painful entheses with dextrose (Enthesis-Dextrose), (2) onto entheses with saline (Enthesis-Saline), or (3) above entheses with saline (Superficial-Saline). All solutions included 0.1% lidocaine. All participants received concurrent programmed physical therapy. MAIN OUTCOME MEASURES: Primary: participants achieving an improvement in maximal current shoulder pain ≥2.8 (twice the minimal clinically important difference for visual analog scale pain) or not. Secondary: improvement in the Ultrasound Shoulder Pathology Rating Scale (USPRS) and a 0-to-10 satisfaction score (10, completely satisfied). RESULTS: The 73 participants had moderate to severe shoulder pain (7.0±2.0) for 7.6±9.6 years. There were no baseline differences between groups. Blinding was effective. At 9-month follow-up, 59% of Enthesis-Dextrose participants maintained ≥2.8 improvement in pain compared with Enthesis-Saline (37%; P=.088) and Superficial-Saline (27%; P=.017). Enthesis-Dextrose participants' satisfaction was 6.7±3.2 compared with Enthesis-Saline (4.7±4.1; P=.079) and Superficial-Saline (3.9±3.1; P=.003). USPRS findings were not different between groups (P=.734). CONCLUSIONS: In participants with painful rotator cuff tendinopathy who receivephysical therapy, injection of hypertonic dextrose on painful entheses resulted in superior long-term pain improvement and patient satisfaction compared with blinded saline injection over painful entheses, with intermediate results for entheses injection with saline. These differences could not be attributed to a regenerative effect. Dextrose prolotherapy may improve on the standard care of painful rotator cuff tendinopathy for certain patients.
RCT Entities:
OBJECTIVE: To compare the effect of dextrose prolotherapy on pain levels and degenerative changes in painful rotator cuff tendinopathy against 2 potentially active control injection procedures. DESIGN: Randomized controlled trial, blinded to participants and evaluators. SETTING:Outpatientpain medicine practice. PARTICIPANTS: Persons (N=73) with chronic shoulder pain, examination findings of rotator cuff tendinopathy, and ultrasound-confirmed supraspinatus tendinosis/tear. INTERVENTIONS: Three monthly injections either (1) onto painful entheses with dextrose (Enthesis-Dextrose), (2) onto entheses with saline (Enthesis-Saline), or (3) above entheses with saline (Superficial-Saline). All solutions included 0.1% lidocaine. All participants received concurrent programmed physical therapy. MAIN OUTCOME MEASURES: Primary: participants achieving an improvement in maximal current shoulder pain ≥2.8 (twice the minimal clinically important difference for visual analog scale pain) or not. Secondary: improvement in the Ultrasound Shoulder Pathology Rating Scale (USPRS) and a 0-to-10 satisfaction score (10, completely satisfied). RESULTS: The 73 participants had moderate to severe shoulder pain (7.0±2.0) for 7.6±9.6 years. There were no baseline differences between groups. Blinding was effective. At 9-month follow-up, 59% of Enthesis-Dextroseparticipants maintained ≥2.8 improvement in pain compared with Enthesis-Saline (37%; P=.088) and Superficial-Saline (27%; P=.017). Enthesis-Dextroseparticipants' satisfaction was 6.7±3.2 compared with Enthesis-Saline (4.7±4.1; P=.079) and Superficial-Saline (3.9±3.1; P=.003). USPRS findings were not different between groups (P=.734). CONCLUSIONS: In participants with painful rotator cuff tendinopathy who receive physical therapy, injection of hypertonicdextrose on painful entheses resulted in superior long-term pain improvement and patient satisfaction compared with blinded saline injection over painful entheses, with intermediate results for entheses injection with saline. These differences could not be attributed to a regenerative effect. Dextrose prolotherapy may improve on the standard care of painful rotator cuff tendinopathy for certain patients.
Authors: Liza Maniquis-Smigel; Kenneth Dean Reeves; Howard Jeffrey Rosen; John Lyftogt; Cassie Graham-Coleman; An-Lin Cheng; David Rabago Journal: Anesth Pain Med Date: 2016-12-06
Authors: Ross A Hauser; Johanna B Lackner; Danielle Steilen-Matias; David K Harris Journal: Clin Med Insights Arthritis Musculoskelet Disord Date: 2016-07-07