NCT01798693终止早期 1 期
Nutritional Supplementation Effects on Rehabilitation Outcomes in Rotator Cuff Pathology
适应症
试验速览
- 阶段
- 早期 1 期
- 状态
- 终止
- 入组人数
- 5
- 试验地点
- 1
- 主要终点
- Change in shoulder function, pain, strength and range of motion
研究概览
简要总结
Rotator Injury:
- Strength/range of Motion
- ASES, VAS
详细描述
The addition of a nutritional therapy to a standardized physical therapy program, may expedite recovery from shoulder injury. An attractive feature of this approach is the development of an efficacious adjunct therapy that is economically superior to traditional therapy modalities and logistically feasible.
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
- Double (Participant, Investigator)
入排标准
- 年龄范围
- 18 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Between 18-65 years old
- •Diagnosed with rotator cuff injury that will not be treated surgically
排除标准
- •Have received a previous injection therapy (platelet-rich plasma or corticosteroid injection) within previous 6 months
- •Have used the following supplements in the previous 2 weeks: Vitamin C or D, or protein supplements
- •Have poorly controlled type I or type II diabetes (HgB A1C > 9.5%) or renal insufficiency (GFR < 60 ml/min).
- •Have an inability to participate in rehabilitation exercises.
- •Are diagnosed with arthritis, rheumatoid arthritis, or any other autoimmune or rheumatologic disease
- •Have musculoskeletal pathology in a neighboring joint or structure
- •Have an allergy to any component of the nutritional supplement
- •Are consuming warfarin
结局指标
主要结局
Change in shoulder function, pain, strength and range of motion
时间窗: Change from baseline to four, six, and twelve weeks
次要结局
未报告次要终点
研究者
Abbie Smith-Ryan, PhD
Assistant Professor
University of North Carolina, Chapel Hill
研究点 (1)
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