Dextrose Prolotherapy Versus Control Injections in Painful Rotator Cuff Tendinopathy.

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.

• Authors: Helene Bertrand, Kenneth Dean Reeves, Cameron J Bennett, Simon Bicknell, An-Lin Cheng
• Journal: Archives of physical medicine and rehabilitation (Arch Phys Med Rehabil) Vol. 97 Issue 1 Pg. 17-25 (Jan 2016) ISSN: 1532-821X [Electronic] United States
• PMID: 26301385 (Publication Type: Comparative Study, Journal Article, Randomized Controlled Trial, Research Support, Non-U.S. Gov't)
• Copyright: Copyright © 2016 American Congress of Rehabilitation Medicine. Published by Elsevier Inc. All rights reserved.

Chemical References

• Irritants
• Glucose

Topics

• Adult
• Aged
• Chronic Pain (diagnostic imaging, etiology, therapy)
• Complementary Therapies
• Double-Blind Method
• Exercise Therapy
• Female
• Glucose (administration & dosage)
• Humans
• Injections, Intra-Articular
• Irritants (administration & dosage)
• Male
• Middle Aged
• Pain Measurement
• Rotator Cuff
• Shoulder Pain (diagnostic imaging, etiology, therapy)
• Tendinopathy (complications, diagnostic imaging, therapy)
• Ultrasonography