Exercise vs. Supplements in Rotator Cuff-Related Shoulder Pain

Study Overview
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Brief Summary
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Rotator cuff-related shoulder pain is a pathology characterized by pain and functional impairment originating from one or more rotator cuff tendons. The lifetime incidence of rotator cuff-related shoulder pain is around 67%, with an annual incidence exceeding 1%. Many patients continue to experience pain and functional loss for up to one year, and more than half of the patients report shoulder pain persisting for over three years. The pathophysiology underlying rotator cuff-related shoulder pain continues to be a subject of ongoing research and uncertainty, with many aspects yet to be fully elucidated. The most common belief regarding its pathogenesis involves the role of inflammation. This hypothesis is supported by the accumulation of inflammatory cells in tendons, oxidative stress, and increased levels of pro-inflammatory cytokines. In tendon pathologies with inflammatory cell accumulation and increased cytokine levels, the use of antioxidants and anti-inflammatory agents in addition to conservative treatment contributes to tendon healing. Anti-oxidants and anti-inflammatories are substances capable of preventing or delaying certain cell damage.The use of anti-inflammatory and antioxidant supplements such as Vitamin C (Vit-C), Vitamin D (Vit-D), Omega-3, and Magnesium (Mg) is recommended. Despite indicating exercise as the gold standard for managing rotator cuff-related shoulder pain and the demonstrated anti-inflammatory and anti-oxidant properties of the mentioned supplements, there are still gaps in the understanding of their effectiveness in rotator cuff-related shoulder pain. Based on these gaps, the goal of this study is to investigate the effects of supplements (Vit-C, Vit-D, Omega-3, and Mg) given in addition to exercise on patients' blood parameters (TNF-a, IL-6, and CRP levels), pain, functional status, quality of life, and patient satisfaction in individuals with rotator cuff-related shoulder pain.

Detailed Description
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58 participants older than 40 years of age with rotator cuff-related shoulder pain for at least 3 months will be included in the study. Signed voluntary consent will be obtained from the patients. Participants will be divided into two groups. Study groups will be as follows: a) Exercise & Supplement Group and b) Exercise Group.

Official Title
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Do Taking Supplements Provide Additional Benefits in Rotator Cuff-Related Shoulder Pain?

Conditions
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Rotator Cuff Syndrome

Intervention / Treatment
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* Other: Exercise
* Other: Supplement


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Being over the age of 40 Diagnosing with rotator cuff-related shoulder pain confirming through clinical examination (Hawkins Kennedy and Empty Can tests) and MRI imaging Having shoulder pain for at least three months Exclusion Criteria: Having full-thickness or massive rotator cuff tear, Having a history of symptoms onset due to trauma, Having a history of surgery on the same shoulder, Having shoulder passive external rotation <30° and flexion <120°, Having shoulder instability, Having an allergy to any supplement, Having psychological, emotional, or cognitive problems Presence of shoulder problems caused by systemic diseases, Presence of diabetes, presence of pregnancy or breastfeeding, Malignancy.

Ages Eligible for Study
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Minimum Age: 40 Years
Maximum Age: 65 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: Participants will be divided into two groups with equal numbers by computer randomization method.
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Exercise & Supplement Group<br>Exercise & Supplement group will take supplements that are prescribed by the orthopedist every day for 8 weeks in addition to a structured exercise program under the supervision of a physiotherapist 3 days per week for 8 weeks. | Other: Exercise<br>* Structured exercise program under the supervision of a physiotherapist 3 days per week for 8 weeks<br>Other: Supplement<br>* Receiving supplement that are prescribed by a orthopedist every day for 8 weeks<br>|
| Active Comparator: Exercise Group<br>Exercise group will follow a structured exercise program under the supervision of a physiotherapist 3 days per week for 8 weeks. | Other: Exercise<br>* Structured exercise program under the supervision of a physiotherapist 3 days per week for 8 weeks<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Visual Analog Scale (VAS) | The scale has range 0 to 10mm. The left side (0mm) shows no pain, and the right side (10mm) shows the most severe pain imaginable. Patients will be asked to mark the severity of their shoulder pain at a point on the scale using this scale. Higher points indicate higher severity and lower points indicate lower severity. | change from baseline pain at 12 weeks | 
| The American Shoulder and Elbow Surgeons Standardized Shoulder Assessment (ASES) | Among the self-assessment of the patients, there are 11 items including pain level and functionality. For pain in scoring, they describe pain of increasing severity between 0 and 10; In functionality, a 4-point Likert-type scale is used to determine whether they can perform activities of daily living or not. The total score ranges from 0 (absence of function) to 100 (normal function). | change from baseline pain at 12 weeks | 
| Quick Disabilities of The Arm, Shoulder and Hand Questionnaire (Quick DASH) | Quick DASH is an 11-item questionnaire used to assess upper extremity functionality. The score ranges from 0 (no injury) to 100 (most severe injury). | change from baseline pain at 12 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Rotator Cuff Quality of Life (RC-QoL) | It is a self-assessment questionnaire consisting of a total of 34 questions and 5 sections assessing the disease-specific quality of life. Each question is assessed on a 100 mm visual analog scale, with 0 representing the lowest score and 100 the best score, and the total score is given as a percentage. Low scores represent low quality of life. | 3 times for 12 weeks | 
| Global Rating of Change Scale (GRC) | It is a scale to evaluate patient satisfaction. It is designed to determine the extent to which the patient improves or worsens over time. In our study, the change between the pre-treatment status of the participants and their current status at the 8th and 12th weeks after the treatment will be questioned. In our study, GRC consisting of 5 levels between -2 and +2 value ranges (-2: I am much worse, -1: I am worse, 0: I am the same, 1: I am better, 2: I am much better) will be preferred. | 3 times for 12 weeks | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Exercise, Physical Therapy, Anti-oxidant, Anti-Inflammatory