๐ฌIn plain words
What the trial is, and whether it could suit you
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
Sign in to get the eligibility rules as simple questions to take to your doctor.
๐ Eligibility rules (as published)
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
๐
What it tests
- Intralesional 5% Dextrose Injection
- Perilesional 5% Dextrose Injection
Ankara Bilkent City Hospital, Physical Medicine and Rehabilitation Hospital
Ankara, Turkey (Tรผrkiye)
๐ค Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible โ always decide together with your own doctor.