Partial thickness tear of Rotator Cuff Tendons of the Shoulder. Unspecified rotator cuff tear or rupture, not specified as traumatic
Conditions
Interventions
Intervention 1: Control group: Inject 3 ml of depomedrol (80 mg of methylprednisolone in a volume of 2 ml and the rest of the saline solution to a final volume of 3 ml). Intervention 2: Platelet-rich
Sponsors
Kerman University of Medical Sciences
Eligibility
Sex/Gender
All
Age
40 Years to 65 Years
Inclusion criteria
Inclusion criteria: Age 40 to 65 years. Diagnosis of incomplete-thickness tear of the Rotator Cuff Tendon (Supraspinatus, Infraspinatus, or Subscapularis) based on MRI (tear less than 50% of the tendon thickness, at the articular or bursal level). Shoulder pain that has not responded to conventional conservative treatments (nonsteroidal anti-inflammatory drugs, physiotherapy). Ability to understand and respond to study questionnaires. Signing an informed consent form.
Exclusion criteria
Exclusion criteria: Full thickness tear of the Rotator Cuff Tendon. History of previous surgery on the affected shoulder. Severe osteoarthritis of the Glenohumeral or Acromioclavicular joint. Presence of systemic inflammatory diseases (such as rheumatoid arthritis). Blood clotting disorders or taking anticoagulant medications that cannot be discontinued. Active infection in the shoulder area or systemic infection. History of malignancy or tumor in the shoulder area. History of corticosteroid injection in the affected shoulder within the past 3 months or PRP injection within the past 12 months. Known sensitivity to any of the materials used in the study. Pregnancy or breastfeeding. Inability to perform follow-up MRI.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| MRI assessment of tendon repair: An MRI of the shoulder will be performed at 6 months after injection. Images will be independently reviewed by an experienced radiologist blinded to treatment group. Repair criteria will include reduction in tear size (length, width, thickness), filling of the tear site with repaired tissue, and improvement in tendon signal quality. Repair will be assessed qualitatively (complete repair, incomplete repair, no repair) and quantitatively (percentage reduction in tear size). Timepoint: An MRI will be taken at the beginning of the study and then 6 months after the injection. Method of measurement: Repair criteria will include reduction in tear size (length, width, thickness), filling of the tear site with repaired tissue, and improvement in tendon signal quality. Repair will be assessed qualitatively (complete repair, incomplete repair, no repair) and quantitatively (percentage of tear size reduction). | — |
Secondary
| Measure | Time frame |
|---|---|
| Evaluation of shoulder function and pain with the ASES (American Shoulder and Elbow Surgeons Score) questionnaire: This questionnaire consists of two sections: pain (50 points) and performance in daily activities (50 points). A higher score indicates better function and less pain. The Persian version of this questionnaire was validated and localized by Mahmoudi Hashemi et al. (2013). In their study, Cronbach's alpha coefficient for measuring internal consistency was 0.91 and the intraclass correlation coefficient (ICC) for test-retest repeatability was 0.91, indicating appropriate validity and reliability of the Persian version. Timepoint: The questionnaire is filled out once at the beginning of the study and once 6 months after the injection. Method of measurement: The ASES (American Shoulder and Elbow Surgeons Score) questionnaire, which includes two sections: pain (50 points) and performance in daily activities (50 points), is used.;Evaluation of shoulder function and pain with the Constant-Murley Score questionnaire: This questionnaire includes assessment of pain (15 points), daily activities (20 points), range of motion (40 points), and strength (25 points). A higher score (maximum 100) indicates better function. The Persian version of this questionnaire has been validated by Jamal Nasab et al. (1401). In their study, Cronbach's alpha coefficient for internal consistency was 0.74 and ICC was calculated for the patient part (95% CI: 89-96) and the physician part (95% CI: 88-96), indicating good reliability. Timepoint: The questionnaire is filled out once at the beginning of the study and once 6 months after the injection. Method of measurement: The Constant-Murley Score questionnaire is used, which includes assessment of pain (15 points), daily activities (20 points), range of motion (40 points), and strength (25 points). | — |
Countries
Iran (Islamic Republic of)
Contacts
Public ContactAmir Reza Sadeghifar
Kerman University of Medical Sciences
Outcome results
None listed