This prospective, randomized, double-blind controlled clinical trial aims to compare the clinical and ultrasonographic outcomes of intralesional and perilesional 5% dextrose injection in patients with partial rotator cuff tears. Eligible participants will be randomized into two parallel groups. Both groups will receive ultrasound-guided 5% dextrose injection to the supraspinatus enthesis. In addition, one group will receive intralesional 5% dextrose injection, while the other group will receive perilesional 5% dextrose injection using the peppering technique. Injections will be performed in three treatment sessions at 21-day intervals. All participants will receive a home-based exercise program after completion of the injection treatments. Clinical outcomes will be assessed at baseline, 9 weeks, and 12 weeks after treatment, and ultrasonographic outcomes will be assessed at baseline and 12 weeks.
Diagnosis of partial rotator cuff tear by a specialist physician after appropriate clinical examination and imaging evaluation
Shoulder pain and functional limitation lasting for at least 3 months
Clinically confirmed shoulder impingement findings, defined as at least one positive test among Neer, Hawkins-Kennedy, or painful arc tests
Age between 18 and 75 years
Advanced cognitive impairment or dementia preventing reliable completion of questionnaires
Refusal to participate in the study or inability to provide informed consent
Full-thickness rotator cuff tear
Major tendon pathology other than the supraspinatus tendon, such as full-thickness subscapularis tear or biceps tendon rupture
Parallel
Intralesional 5% Dextrose Injection
Procedure/SurgeryUltrasound-guided 5% dextrose injection will be applied to the supraspinatus enthesis and additionally into the partial tear lesion using the peppering technique. A volume of 0.1-0.2 cc will be administered to each point. The treatment will consist of three sessions performed at 21-day intervals.
Perilesional 5% Dextrose Injection
Procedure/SurgeryUltrasound-guided 5% dextrose injection will be applied to the supraspinatus enthesis and additionally around the partial tear lesion using the peppering technique. A volume of 0.1-0.2 cc will be administered to each point. The treatment will consist of three sessions performed at 21-day intervals.
Change in Shoulder Pain Intensity Assessed by Numeric Rating Scale
Shoulder pain intensity will be assessed using the Numeric Rating Scale. Night pain, worst daytime shoulder pain, and average shoulder pain will be evaluated on a 0-10 scale, where 0 indicates no pain and 10 indicates the worst pain imaginable. Higher scores indicate greater pain intensity.
Change in Shoulder Pain and Disability Assessed by the Shoulder Pain and Disability Index
Shoulder pain and disability will be assessed using the Shoulder Pain and Disability Index. The scale consists of 13 items in two domains: pain and disability. Each item is scored from 0 to 10, and the total score is converted to a 0-100 scale. Higher scores indicate greater pain and functional impairment.
Change in Health-Related Quality of Life Assessed by the Short Form-12 Health Survey
Health-related quality of life will be assessed using the Short Form-12 Health Survey. The questionnaire includes 12 items and provides physical component summary and mental component summary scores. Higher scores indicate better health-related quality of life.
Change in Supraspinatus Tendon Thickness Assessed by Ultrasonography
Supraspinatus tendon thickness will be measured in millimeters using shoulder ultrasonography with a high-frequency linear probe in a standardized position.
Change in Partial Rotator Cuff Defect Size Assessed by Ultrasonography
Partial rotator cuff defect size will be measured in millimeters using shoulder ultrasonography with a high-frequency linear probe in a standardized position.
Click on the lead sponsor to view all of their trials.
