An interventional study of Prolotherapy group and Corticosteroid group in Sub Acromial Impingement Syndrome, sponsored by Mustafa Kemal University. Completed at 1 site in Turkey (Türkiye). Open to participants aged 20 Years to 55 Years. Per ClinicalTrials.gov, last updated 2026-11-06.
Sponsored by Mustafa Kemal University · Not applicable, Interventional, and Treatment
Subacromial impingement syndrome is a common cause of shoulder pain and difficulty with arm movements. This study compared two injection treatments: ultrasound-guided dextrose prolotherapy and corticosteroid injection. A total of 32 patients aged 20-55 years were randomly assigned to one of the two treatment groups. Both groups also received a home exercise program. Pain, shoulder-related pain and disability, and shoulder range of motion were assessed before treatment and at 1 and 3 months after treatment. Thirty patients completed the follow-up and were included in the final analysis. The aim was to compare the clinical outcomes of the two treatments over the 3-month follow-up period. The findings may help improve understanding of these treatment options for patients with subacromial impingement syndrome.
Mustafa Kemal University is the lead sponsor of 77 studies on the registry; 18 are open to participants now.
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Patients in the prolotherapy group received 9 mL of 10% dextrose solution mixed with 1 mL of 1% lidocaine under ultrasound guidance. The total injection volume was 10 mL. The injection was administered to the humeral attachment/enthesis region of the rotator cuff tendon identified as affected on the basis of clinical examination and ultrasonographic findings. After gentle contact with the cortical bone, the needle was slightly withdrawn, and approximately 1-2 mL of the solution was injected at each enthesis site. Two treatment sessions were performed one month apart.
Procedure: Prolotherapy group
Patients in the corticosteroid group received a single ultrasound-guided injection into the subacromial-subdeltoid bursa. The injection solution consisted of 1 mL of methylprednisolone acetate (40 mg), 1 mL of 1% lidocaine, and 3 mL of normal saline, for a total volume of 5 mL.
Procedure: Corticosteroid group
Patients in the prolotherapy group received 9 mL of 10% dextrose solution mixed with 1 mL of 1% lidocaine under ultrasound guidance. The total injection volume was 10 mL. The injection was administered to the humeral attachment/enthesis region of the rotator cuff tendon identified as affected on the basis of clinical examination and ultrasonographic findings. After gentle contact with the cortical bone, the needle was slightly withdrawn, and approximately 1-2 mL of the solution was injected at each enthesis site. Two treatment sessions were performed one month apart.
Patients in the corticosteroid group received a single ultrasound-guided injection into the subacromial-subdeltoid bursa. The injection solution consisted of 1 mL of methylprednisolone acetate (40 mg), 1 mL of 1% lidocaine, and 3 mL of normal saline, for a total volume of 5 mL.
Visual Analogue Scale(VAS)
Pain intensity was assessed using the Visual Analogue Scale (VAS), a 10-cm horizontal line on which patients mark their pain level. Scores range from 0 (no pain) to 10 (worst imaginable pain). Higher scores indicate a worse outcome.
Time frame: From the enrollment phase to the end of the 12-week treatment period
Shoulder Pain and Disability Index (SPADI)
Shoulder pain and function were assessed using the Shoulder Pain and Disability Index (SPADI), a 13-item self-reported questionnaire consisting of a pain subscale (5 items) and a disability subscale (8 items). The total score ranges from 0 (best) to 100 (worst). Higher scores indicate greater pain and disability, i.e., a worse outcome.
Time frame: From the enrollment phase to the end of the 12-week treatment period
ROM
Active shoulder range of motion (ROM) was measured in degrees using a universal goniometer for flexion, abduction, internal rotation, and external rotation. Internal and external rotation were measured with the shoulder at 90° abduction. Normal reference ranges are 0-180° for flexion, 0-180° for abduction, 0-90° for internal rotation, and 0-90° for external rotation. Higher values indicate greater mobility, i.e., a better outcome.
Time frame: From the enrollment phase to the end of the 12-week treatment period
Plan to share: No — Individual participant-level data will not be publicly shared because the dataset contains sensitive health information and sharing these data may compromise participant confidentiality and privacy. The study data were collected under the approval of the institutional ethics committee, and public sharing of identifiable or potentially identifiable individual data was not included in the original consent process.
Ran from Oct 2021 to primary completion in Feb 2023, 16 months.
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This study is completed, as verified in Oct 2026. You cannot join it, but the record below documents what was studied.
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Mustafa Kemal University