NCT04805242

Effects of Dextrose Prolotherapy in Rotator Cuff Disease

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

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 60 (actual)
• Sponsor: Istanbul University · Academic / Other
• Sex: All
• Age: 30 Years – 65 Years
• Healthy volunteers: Not accepted

Summary

The aim of this prospective, randomized, controlled, single-blind study was to evaluate the effects of dextrose prolotherapy on pain and functional outcomes in patients with chronic rotator cuff disease.

Detailed description

Rotator cuff disease is a major cause of shoulder pain and disability. Non-surgical treatments aimed at reducing pain and improving function include therapeutic exercises, nonsteroidal anti-inflammatory drugs, and subacromial corticosteroid injections. However, some patients remain symptomatic despite these conservative treatments. Prolotherapy has recently gained increasing attention as a treatment option for various musculoskeletal conditions. In patients with chronic rotator cuff disease resistant to conventional treatment, regenerative injection approaches such as dextrose prolotherapy may offer potential clinical benefits. In this prospective, randomized, controlled, single-blind interventional study, 60 patients with shoulder pain due to rotator cuff disease who met the eligibility criteria were enrolled. Participants were randomly assigned to one of two groups using computer-generated random numbers. In the dextrose prolotherapy group, prolotherapy injections were administered at baseline, week 3, and week 6 using an ultrasound-guided marking technique under aseptic conditions. In the control group, saline injections were administered at the same time points. Both groups received a standardized home exercise program. Participants were evaluated at baseline and at the 1-month and 3-month follow-ups using the Visual Analog Scale (VAS) for activity-related, resting, and night pain, the Shoulder Pain and Disability Index (SPADI), the UCLA Shoulder Rating Scale, shoulder active range of motion, and the Ultrasound Shoulder Pathology Rating Scale (USPRS).

Conditions

• Rotator Cuff Disease

Interventions

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

Timeline

• Start date: 2021-03-18
• Primary completion: 2021-10-12
• Completion: 2021-11-12
• First posted: 2021-03-18
• Last updated: 2026-03-10

Locations

1 site across 1 country: Turkey (Türkiye)