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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.
Rotator cuff tears are one of the leading causes of shoulder pain and functional limitation. Partial rotator cuff tears may become chronic and may not respond adequately to conventional conservative treatments such as activity modification, physical therapy, and nonsteroidal anti-inflammatory drugs.
Dextrose injection is a regenerative injection therapy that aims to stimulate tissue healing responses in chronic musculoskeletal disorders. It is thought to promote fibroblast activation, collagen synthesis, and proliferative healing processes in degenerative tendon, ligament, and enthesis lesions. Ultrasound guidance allows accurate and safe delivery of the injectate to the target tissue and enables objective follow-up of tendon morphology during the treatment process.
This study will include adult patients with partial rotator cuff tears diagnosed by clinical examination and imaging. Participants will be randomized into two groups using a computer-based random number system. The researcher performing the randomization will know the treatment allocation, while the participants and the physician assessing the clinical outcomes will be blinded to treatment groups.
Both groups will receive ultrasound-guided 5% dextrose injection to the supraspinatus enthesis. The intralesional group will additionally receive intralesional 5% dextrose injection, and the perilesional group will additionally receive perilesional 5% dextrose injection. Injections will be applied using the peppering technique, with 0.1-0.2 cc administered to each point. A total of three treatment sessions will be performed at 21-day intervals.
Clinical outcomes will include shoulder pain assessed by the Numeric Rating Scale, shoulder pain and disability assessed by the Shoulder Pain and Disability Index, and health-related quality of life assessed by the Short Form-12 Health Survey. Ultrasonographic outcomes will include supraspinatus tendon thickness and partial defect size. Clinical evaluations will be performed at baseline, 9 weeks, and 12 weeks after treatment. Ultrasonographic evaluations will be performed at baseline and 12 weeks.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Intralesional 5% Dextrose Injection | Experimental | Participants in this group will receive ultrasound-guided 5% dextrose injection to the supraspinatus enthesis. In addition, intralesional 5% dextrose injection will be applied to the partial rotator cuff tear 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. |
|
| Perilesional 5% Dextrose Injection | Active Comparator | Participants in this group will receive ultrasound-guided 5% dextrose injection to the supraspinatus enthesis. In addition, perilesional 5% dextrose injection will be applied around the partial rotator cuff tear 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. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Intralesional 5% Dextrose Injection | Procedure | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | Baseline, 9 weeks, and 12 weeks after treatment |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | Baseline, 9 weeks, and 12 weeks after treatment |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Esra Ülgen Kıratlıoğlu, MD | Contact | +905079614194 | esraulgen@gmail.com |
| Name | Affiliation | Role |
|---|---|---|
| ESRA Ülgen Kıratlıoğlu | Ankara City Hospital Bilkent | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Ankara Bilkent City Hospital, Physical Medicine and Rehabilitation Hospital | Recruiting | Ankara | Turkey (Türkiye) |
Individual participant data will not be shared due to privacy and ethical restrictions.
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Participants will be randomized into two parallel groups: intralesional 5% dextrose injection and perilesional 5% dextrose injection.
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Participants and the outcomes assessor will be blinded to treatment allocation.
|
| Perilesional 5% Dextrose Injection | Procedure | 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. |
|
| 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. | Baseline, 9 weeks, and 12 weeks after treatment |
| 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. | Baseline and 12 weeks after treatment |
| 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. | Baseline and 12 weeks after treatment |
| ID | Term |
|---|---|
| D020069 | Shoulder Pain |
| ID | Term |
|---|---|
| D018771 | Arthralgia |
| D007592 | Joint Diseases |
| D009140 | Musculoskeletal Diseases |
| D010146 | Pain |
| D009461 | Neurologic Manifestations |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
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| ID | Term |
|---|---|
| D005947 | Glucose |
| ID | Term |
|---|---|
| D006601 | Hexoses |
| D009005 | Monosaccharides |
| D000073893 | Sugars |
| D002241 | Carbohydrates |
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