Do Taking Supplements Provide Additional Benefits in Rotator Cuff-Related Shoulder Pain?
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- 入组人数
- 58
- 试验地点
- 2
- 主要终点
- The American Shoulder and Elbow Surgeons Standardized Shoulder Assessment (ASES)
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Single (Outcomes Assessor)
盲法说明
The investigator administering the treatment and the investigator performing the assessment will be different. The assessor will not know about the interventions that the participants received.
入排标准
- 年龄范围
- 40 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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
排除标准
- •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.
结局指标
主要结局
The American Shoulder and Elbow Surgeons Standardized Shoulder Assessment (ASES)
时间窗: change from baseline pain at 12 weeks
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).
Quick Disabilities of The Arm, Shoulder and Hand Questionnaire (Quick DASH)
时间窗: change from baseline pain at 12 weeks
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).
Visual Analog Scale (VAS)
时间窗: change from baseline pain at 12 weeks
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.
次要结局
- Rotator Cuff Quality of Life (RC-QoL)(3 times for 12 weeks)
- Global Rating of Change Scale (GRC)(3 times for 12 weeks)
研究者
Aysenur Erekdag
Principal Investigator
Istanbul University - Cerrahpasa