Intralesional Versus Perilesional 5% Dextrose Injection in Partial Rotator Cuff Tears
Recruiting now · Not applicable
Conditions studied: Partial Rotator Cuff Tears, Rotator Cuff Tendinopathy, Shoulder Pain Chronic, Supraspinatus Tendon Tear
In brief
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.
Key facts
- Study ID
- NCT07688902
- Run by
- Ankara City Hospital Bilkent
- People needed
- 30
- Starts
- 2025-02-01
- Expected to finish
- 2026-10-01
- Last updated by the study team
- 2026-07-07
Who can join
Age: 18 and older, up to 75. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- 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
You may not qualify if…
- 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
Where it is running
- Ankara Bilkent City Hospital, Physical Medicine and Rehabilitation Hospital — Ankara, Turkey (Türkiye) (enrolling)
Full record on ClinicalTrials.gov
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