RecruitingNot Applicable

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

Turkey (Türkiye)30 participantsStarted 2025-02-01

Plain-language 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.

Who can participate

Age range

18 Years – 75 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

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…

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1This trial is comparing two different injection approaches — one directly into the tear and one around it — so which method does my doctor currently think is more likely to help my specific type of partial rotator cuff tear, and why?
2Since this trial is listed as Phase NA, meaning it's not a standard drug-efficacy phase trial, what does that tell us about how much is already known about the safety of dextrose injections for rotator cuff tendinopathy, and are there any risks I should specifically be aware of?
3The trial is measuring changes in shoulder pain using a numeric rating scale as its main outcome — does that mean we won't have good information yet about whether the injection actually helps the tear heal structurally, and is pain relief alone enough of a goal for my situation?
4Before considering this trial, should I try standard treatments for my partial supraspinatus tear first — like physical therapy or corticosteroid injections — and would participating in this study rule out or delay those options?
5Since this trial involves two different injection sites and I'd likely be assigned to one group, can my doctor help me understand how that assignment works and whether I'd still have access to the other approach if the one I receive doesn't help my shoulder pain?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

Change in Shoulder Pain Intensity Assessed by Numeric Rating Scale

Timeframe: Baseline, 9 weeks, and 12 weeks after treatment

Trial details

NCT IDNCT07688902

SponsorAnkara City Hospital Bilkent

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2026-10-01

Contact for this trial

Esra Ülgen Kıratlıoğlu, MD

+905079614194 esraulgen@gmail.com

View on ClinicalTrials.gov More Partial Rotator Cuff Tears trials