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 receive physical 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.
Keywords
List of abbreviations:
ANCOVA (analysis of covariance), NRS (numeric rating scale), USPRS (Ultrasound Shoulder Pathology Rating Scale), VAS (visual analog scale)To read this article in full you will need to make a payment
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Article info
Publication history
Published online: August 21, 2015
Footnotes
Supported by WorkSafeBC (Workers' Compensation Board of British Columbia; grant no. RS2010-OG07). The funding source has no involvement in conduct of the research or preparation of the article.
Clinical Trial Registration No.: NCT01402011.
Disclosures: none.
Identification
Copyright
© 2016 American Congress of Rehabilitation Medicine. Published by Elsevier Inc. All rights reserved.
