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Effects of Dextrose Prolotherapy in Rotator Cuff Disease

NCT04805242 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 60

Last updated 2026-03-10

No results posted yet for this study

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.

Conditions

  • Rotator Cuff Disease

Interventions

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.

Sponsors & Collaborators

  • Istanbul University

    lead OTHER

Principal Investigators

  • Selim Sezikli, MD · Istanbul University Istanbul Faculty of Medicine, Department of Physical Medicine and Rehabilitation

  • Demirhan Diracoglu, Prof. · Istanbul University Istanbul Faculty of Medicine, Department of Physical Medicine and Rehabilitation

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
30 Years
Max Age
65 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2021-03-18
Primary Completion
2021-10-12
Completion
2021-11-12

Countries

  • Turkey (Türkiye)

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04805242 on ClinicalTrials.gov