Objective: To determine whether dextrose prolotherapy offers clinical benefits in patients with shoulder pain and bursitis.
Design: Double-blinded, randomized controlled trial.
Setting: Outpatient rehabilitation department of a single medical center.
Participants: Patients (N=50) who had received a diagnosis of shoulder pain and bursitis through clinical tests and ultrasound examination.
Interventions: Participants were randomly assigned to the 15% dextrose injection (D15W) group or the placebo group to receive either D15W or normal saline injection, respectively. All participants received ultrasound-guidance bursal injection every 2 weeks for a total of 3 injections.
Main outcome measures: The primary outcome was maximal pain level while performing activities. The secondary outcomes included resting pain level, function and disability assessment results, and ultrasonographic parameters. Participants were followed up for 3 months after completion of the injection course.
Results: No significant differences in baseline characteristics were observed between the D15W and placebo groups. Significant time effects were observed for all outcome parameters (all P<.05); however, time × group effects were nonsignificant for all outcomes, except for tissue elasticity (P=.026).
Conclusions: Supporting evidence is insufficient regarding the clinical benefits of 15% dextrose bursal injection administered through 3 sessions in patients with chronic shoulder pain and bursitis. The findings indicate that these injections may increase the tissue stiffness of the supraspinatus tendon, as indicated by elastography assessment results, but further research is required to determine the nature of such changes in elastography findings.
Trial registration: ClinicalTrials.gov NCT03447158.
Keywords: Elastography; Injections; Prolotherapy; Rehabilitation; Rotator cuff injuries; Shoulder impingement syndrome.
Copyright © 2020 American Congress of Rehabilitation Medicine. Published by Elsevier Inc. All rights reserved.