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Clinical Trials in Turkey / NCT07688902
Recruiting Not applicable

Intralesional Versus Perilesional 5% Dextrose Injection in Partial Rotator Cuff Tears

NCT07688902 · tracked via the Priya Life Science Turkey tracker
Phase
Not applicable
Started
2025-02-01
Last updated
2026-07-07

Condition(s) studied

Partial Rotator Cuff TearsRotator Cuff TendinopathyShoulder Pain ChronicSupraspinatus Tendon Tear

Investigational drug(s) / intervention(s)

Intralesional 5% Dextrose InjectionPerilesional 5% Dextrose Injection

Intralesional 5% Dextrose Injection: Ultrasound-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: Ultrasound-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.

Study summary

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.

Eligibility

Sex
ALL
Min age
18 Years
Max age
75 Years
Healthy volunteers
No
Inclusion Criteria: * 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 * Ability to comply with the study procedures and attend follow-up visits regularly * Willingness to participate in the study and provide written informed consent Exclusion Criteria: * 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 * Advanced acromioclavicular joint osteoarthritis, marked impingement, or marked adhesive capsulitis * Advanced glenohumeral joint arthritis * Active infection, cellulitis, or dermatologic lesion at the injection site * Bleeding diathesis or anticoagulant use * Known allergy or intolerance to dextrose injection * Intra-articular shoulder injection, including steroid, platelet-rich plasma, or prolotherapy, within the last 3 months * Previous shoulder surgery * Uncontrolled diabetes mellitus, defined as HbA1c \>8.5%, or severe endocrine or metabolic disorder * Immunosuppression or active infection * Rheumatologic shoulder involvement * Neurological disease affecting shoulder movements * Pregnancy * Active malignancy

Primary outcome measure(s)

Trial sites (1)

FacilityCityRegionStatus
Ankara Bilkent City Hospital, Physical Medicine and Rehabilitation Hospital Ankara Turkey (Türkiye) Recruiting

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Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT07688902 on ClinicalTrials.gov ↗ ← All trials in Turkey