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COMPLETED
NCT04805242
NA

Effects of Dextrose Prolotherapy in Rotator Cuff Disease

Sponsor: Istanbul University

View on ClinicalTrials.gov

Summary

The aim of this prospective, randomized, controlled trial was to evaluate the clinical and ultrasonographic effects of dextrose prolotherapy on pain, shoulder function, range of motion, and ultrasonographic findings in patients with MRI-confirmed chronic rotator cuff disease. Participants were randomly assigned to receive either dextrose prolotherapy or lidocaine-saline injections. Both groups followed a standardized home-based exercise program.

Official title: Effects of Dextrose Prolotherapy in Rotator Cuff Disease: A Randomized Controlled Study

Key Details

Gender

All

Age Range

30 Years - 65 Years

Study Type

INTERVENTIONAL

Enrollment

60

Start Date

2021-03-18

Completion Date

2021-11-12

Last Updated

2026-07-02

Healthy Volunteers

No

Interventions

OTHER

Dextrose prolotherapy injection

Dextrose prolotherapy injections were administered at baseline, week 3, and week 6 using an ultrasound-guided anatomical marking technique. A 15% dextrose solution was prepared using 30% dextrose, saline, and 1% lidocaine. Extra-articular injections were administered with a 27-gauge needle using the peppering technique at five previously marked anatomical points, including the long head of the biceps tendon in the bicipital groove, the subscapularis insertion at the lesser tuberosity, the supraspinatus insertion at the greater tuberosity, the infraspinatus insertion at the greater tuberosity, and the coracoid process region. One milliliter was injected at each point. Subacromial injection was performed via a posterior approach using a 21-gauge needle, and 4 mL of solution was injected into the subacromial bursa. All participants also received a standardized home-based exercise program.

OTHER

Lidocaine-saline injection

Lidocaine-saline injections were administered at baseline, week 3, and week 6 using the same ultrasound-guided anatomical marking technique and anatomical targets as the prolotherapy group. Extra-articular injections were prepared using saline and 1% lidocaine and were administered superficially at approximately 0.5-1 cm depth using a 26-gauge needle at five previously marked sites to mimic the prolotherapy injection procedure. One milliliter was injected at each site. Subacromial injection was performed via a posterior approach using a 21-gauge needle, and 4 mL of lidocaine-saline solution was injected into the subacromial bursa. All participants also received a standardized home-based exercise program.

Locations (1)

Istanbul University Istanbul Faculty of Medicine, Department of Physical Medicine and Rehabilitation

Istanbul, Fatih, Turkey (Türkiye)