About this trial
Rotator cuff tears are a significant health concern that severely affect shoulder joint mobility in patients. Common clinical manifestations of RCTs include shoulder pain, limited range of motion, joint instability, muscle weakness, and functional disability. In patients with rotator cuff tears, the prevalence of vitamin D deficiency ranges from 8.3% to 71%. Given its critical role in muscle strength and function, vitamin D is emerging as an important factor in the management of musculoskeletal disorders, including rotator cuff injuries. Despite the promising evidence regarding vitamin D's role in muscle strength and tendon healing, the specific impact of vitamin D supplementation on postoperative rehabilitation remains unclear. Given that vitamin D deficiency is easily diagnosed and treated, it is considered a modifiable risk factor that could be utilized in orthopedic care to improve patient outcomes. Vitamin D supplementation is a cost-effective and potentially efficient intervention that may enhance muscle strength, reduce postoperative pain, and improve joint function in patients recovering from rotator cuff repair. The objective of this study is to investigate the effects of vitamin D supplementation on postoperative outcomes in patients undergoing arthroscopic rotator cuff repair. The study will be conducted as a randomized controlled trial, with participants receiving either a daily dose of 4000 IU of vitamin D or a placebo. The primary outcomes to be evaluated include muscle strength, postoperative pain, and joint function. Blood samples will be collected at baseline, and after 3 months, 6 months, and 12 months of supplementation to monitor the effects of vitamin D on serum levels and its correlation with clinical outcomes.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Male and female patients aged between 40 and 70 years.
Clinically and radiologically (magnetic resonance imaging) diagnosed full-thickness supraspinatus tendon tears that were confirmed by arthroscopic surgery and could be surgically repaired.
Degree of supraspinatus tendon tear according to the DeOrio and Cofield grading system as moderate tear (1-3 cm) and mild tear (<1 cm).
Serum vitamin D level <30 ng/mL >20 ng/mL before rotator cuff tears surgery
Disqualifiers
Presence of other shoulder pathologies such as subscapularis tear, adhesive capsulitis, long head of biceps tendonitis, calcific tendonitis, or shoulder tumor.
Large or unrepairable rotator cuff tear (>3 cm).
Previous history of shoulder surgery or recurrent rotator cuff tears.
Combined injury to the shoulder labrum, articular cartilage or biceps tendon.
Trial design
Parallel
Treatments tested in this trial
Vitamin D
Drug4000IU/day vitamin D supplement will be used for 6 months
Placebo
DrugPlacebo will be used for 6 months
Treatment groups
Trial outcomes
Primary outcomes
External and internal rotation isometric strength of the shoulder
Isometric shoulder strength will be tested using an isokinetic dynamometer (Biodex System 2, Shirley, New York). Following the protocol described by Hughes and colleagues, strength testing will be performed at the following joint positions: coronal-plane abduction (ABD) at 30° of abduction, internal rotation (IR) at 15° of frontal-plane elevation and 0° of humeral rotation, and external rotation (ER) at 15° of frontal-plane elevation and 0° of humeral rotation. To isolate shoulder strength and minimize the likelihood of compensation with other muscle groups, patients will be secured to the Biodex system with 2 hook-and-loop straps diagonally across their torso. Three trials will be performed at each position, with at least 2 minutes of rest between each trial. The average of the 3 trials will be calculated and recorded as the patient's maximum isometric strength. Both shoulders will be tested, and the testing order will be randomized. To account for any inherent differences in strengt
Secondary outcomes
Visual Analog Scale (VAS)
The VAS is used for determination of the pain intensity. The VAS scale is represented as a 10 cm-long line. The left side of the line (0) corresponds to "no pain" and the right side (10) represents "the worst pain ever"
the American Shoulder and Elbow Surgeons (ASES) score
The ASES questionnaire is used for evaluation. The ASES score consists of two subscales: activities of daily living (ADL) and pain. It is a patient-reported outcome measure, ranging from 0 (severe pain and complete loss of function) to 50 (no pain and good function) for each subscale. The total score is obtained by summing the two subscale scores, with a maximum possible score of 100 points
the University of California, Los Angeles (UCLA) score
The UCLA Shoulder Score is a widely used scale for evaluating shoulder function following rotator cuff repair. It primarily assesses shoulder pain, function, range of motion, and patient satisfaction with the outcomes of shoulder treatment
the Constant-Murley score
The Constant-Murley Score, introduced by Constant and Murley, is another commonly used questionnaire for shoulder assessment. It evaluates various aspects of shoulder function, including range of motion, strength, and overall functionality. The range of motion assessment is comprehensive, covering forward flexion, external rotation, abduction, and internal rotation. The total score ranges from 0 to 100, with higher scores indicating better shoulder function
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