Clinical trial NCT06984068: Effect of Vitamin D Supplementation on the Rehabilitation of Patients After Rotator Cuff Tear Repair
Official title: Effect of Vitamin D Supplementation on the Rehabilitation of Patients After Rotator Cuff Tear Repair: a Double-blind Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: Rotator Cuff Tear
Keywords: rotator cuff tear
rotator cuff tear repair
vitamin D
Lead sponsor: Chinese University of Hong Kong
Sponsor class: OTHER
First posted: 2025-05-22
Enrollment: 44
Sex: ALL
Minimum age (years): 40
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: 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.

Detailed description: Rotator cuff tears is one of the diseases that severely affect the movement of the shoulder joint in patients. The clinical manifestations of rotator cuff tears typically include shoulder pain, restricted range of motion, joint instability, muscle weakness, and functional disability. Epidemiological data reveal a progressive increase in the prevalence of rotator cuff injuries among middle-aged and older adults. The prevalence is estimated to be approximately 15-20% in individuals aged 60 years, 26-30% in those aged 70 years, and up to 50% in individuals aged 80 years.

Risk factors for rotator cuff tears are multifactorial, including age, smoking, hypercholesterolemia, history of trauma or repetitive overhead activity, dominant arm injury, and family history of shoulder problems. The wide variation in the causes of rotator cuff tears, coupled with the prevalence of asymptomatic tears, has contributed to a lack of standardization in treatment approaches. While physical therapy and regenerative medicine treatments, such as platelet-rich plasma (PRP) and stem cell therapy, have been explored as potential alternatives, evidence suggests that the intrinsic healing capacity of the rotator cuff is limited. Arthroscopic rotator cuff repair is considered the treatment of choice for acute tears across all age groups, as well as for patients under the age of 65 with chronic, large (\>1 cm), reparable tears and no irreversible muscle changes. Despite advancements in surgical techniques, the rehabilitation process remains challenging due to the biomechanical complexity of the shoulder and the multifactorial nature of recovery. Many patients experience suboptimal outcomes, including muscle weakness, persistent pain, functional limitations, and re-tearing of the rotator cuff.

Vitamin D insufficiency or deficiency is widely recognized as being closely associated with the development of various conditions, including osteoporosis, fractures, and muscle weakness. It is estimated that up to 32% of the U.S. population and as many as one billion people worldwide are affected by Vitamin D deficiency or insufficiency (defined as a 25(OH)D3 level \>20 ng/mL but \<30 ng/mL). The prevalence of Vitamin D deficiency is notably high among orthopedic patient populations. A retrospective study revealed that 43% of patients undergoing preoperative evaluation exhibited Vitamin D insufficiency, with 40% classified as deficient. Vitamin D deficiency prevalence ranges from 8.3% to 71% in patients with rotator cuff tears. Vitamin D's impact on muscle strength and function has made it a subject of increasing interest in the management of musculoskeletal disorders, including rotator cuff injuries.

Current research on rotator cuff injuries has indicated a potential role for vitamin D in enhancing tendon healing. By inhibiting matrix metalloproteinases (MMPs), which hinder rotator cuff repair, vitamin D facilitates the accumulation of fibrocartilage and collagen, thereby improving tendon healing. Animal experiments have shown that vitamin D supplementation can enhance muscle fiber size, improve muscle function, reduce the expression of pro-fibrotic genes, and increase the expression of anti-fibrotic genes. This, in turn, helps mitigate muscle fatty infiltration and improve skeletal muscle quality regulation signaling pathways. One study reported through regression analysis that serum vitamin D levels were significantly negatively correlated with rotator cuff fatty degeneration. Furthermore, another study conducted muscle biopsies on patients undergoing rotator cuff repair and compared those deficient in vitamin D with patients who had sufficient levels. They found significantly increased expression of pro-inflammatory genes IL1β and IL6 in the deltoid and supraspinatus muscles of vitamin D-deficient individuals. This heightened postoperative inflammatory response may delay muscle repair and functional recovery, leading to suboptimal rehabilitation outcomes. Low vitamin D concentrations may serve as an independent variable contributing to fatty infiltration and degeneration of the supraspinatus and infraspinatus muscles. Another study demonstrated a significant association between low preoperative vitamin D levels and increased complications following rotator cuff repair. In patients undergoing arthroscopic rotator cuff repair, lower vitamin D levels were correlated with more severe muscle weakness at one year postoperatively. Additionally, preoperative vitamin D deficiency has been linked to higher re-tear rates and increased early postoperative pain.

Despite the promising evidence, the specific role of vitamin D in postoperative rehabilitation remains unclear. Given the ease of diagnosis and treatment of vitamin D deficiency, it is considered a highly modifiable risk factor in orthopedic care. Vitamin D supplementation holds promise as a cost-effective and efficient intervention that may improve postoperative outcomes, including enhanced muscle strength and joint function, in patients undergoing rotator cuff repair. Therefore, this study aims to investigate the effects of vitamin D supplementation on postoperative outcomes in patients undergoing arthroscopic rotator cuff repair. Using a randomized controlled trial (RCT) design, this study will evaluate the impact of vitamin D supplementation on muscle strength, postoperative pain, and joint function in patients with rotator cuff tears.

Eligibility criteria: Inclusion Criteria:

1. Male and female patients aged between 40 and 70 years.
2. Clinically and radiologically (magnetic resonance imaging) diagnosed full-thickness supraspinatus tendon tears that were confirmed by arthroscopic surgery and could be surgically repaired.
3. Degree of supraspinatus tendon tear according to the DeOrio and Cofield grading system as moderate tear (1-3 cm) and mild tear (\<1 cm).
4. Serum vitamin D level \<30 ng/mL \>20 ng/mL before rotator cuff tears surgery
5. Signed informed consent and underwent 12-month follow-up.

Exclusion Criteria:

1. Presence of other shoulder pathologies such as subscapularis tear, adhesive capsulitis, long head of biceps tendonitis, calcific tendonitis, or shoulder tumor.
2. Large or unrepairable rotator cuff tear (\>3 cm).
3. Previous history of shoulder surgery or recurrent rotator cuff tears.
4. Combined injury to the shoulder labrum, articular cartilage or biceps tendon.
5. Contraindications to vitamin D supplementation (e.g., allergies).
6. Serious comorbidities such as cardiovascular disease.
7. Severe osteoporosis or rheumatoid arthritis.

Primary outcomes:
measure: External and internal rotation isometric strength of the shoulder
timeFrame: Baseline, 3 months, 6 months and 12 months post-intervention
Secondary outcomes:
measure: Visual Analog Scale (VAS)
timeFrame: Baseline, 3 months, 6 months and 12 months post-intervention
measure: the American Shoulder and Elbow Surgeons (ASES) score
timeFrame: Baseline, 3 months, 6 months and 12 months post-intervention
measure: the University of California, Los Angeles (UCLA) score
timeFrame: Baseline, 3 months, 6 months and 12 months post-intervention
measure: the Constant-Murley score
timeFrame: Baseline, 3 months, 6 months and 12 months post-intervention
measure: Range of motion (ROM)
timeFrame: Baseline, 3 months, 6 months and 12 months post-intervention
measure: Magnetic resonance imaging (MRI)
timeFrame: Baseline, 12 months post-intervention
measure: Serum vitamin D assays
timeFrame: Baseline, 12 months post-intervention
Other outcomes:
Locations:
city: HongKong
country: Hong Kong
facility: Prince of Wales Hospital
Study officials:
References: