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临床试验/NCT05821283
NCT05821283已完成不适用

Does Physical Activity Provide Additional Benefit In Patients With Rotator Cuff Related Shoulder Pain? A Randomized Controlled Trial

Istanbul University1 个研究点 分布在 1 个国家目标入组 42 人开始时间: 2023年5月1日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
42
试验地点
1
主要终点
Numeric Pain Rating Scale (NPRS)-activity

研究概览

简要总结

Rotator cuff-related shoulder pain (RCRSP) are among the most common musculoskeletal disorders and can be associated with pain, weakness, shoulder dysfunction and kinesiophobia. The management could be surgery or nonsurgical options such as medical treatment, education, activity modifications and physiotherapy. Physical activity is defined as any body movement produced by skeletal muscles that requires a certain amount of energy expenditure. Regular physical activity is proven to help prevent and manage many diseases. Beyond these people, doing physical activity have better mental health, emotional wellbeing, quality of life and lower rates of mental illness. Additionally, physical activity and exercise applications are used as an alternative method to reduce the severity and frequency of pain in patients with chronic pain. Investigators reviewed the literature, we could not find any randomized controlled trial on the effectiveness of physical activity in studies conducted with patients with RCRSP. Investigators hypothesized that adding physical activity to the treatment of RCRSP would make a significant difference. Therefore, the aim of this study was to investigate the effect of physical activity applied in addition to supervised exercise on pain, functional status and quality of life in patients with RCRSP.

详细描述

Rotator cuff-related shoulder pain (RCRSP) are among the most common musculoskeletal disorders and can be associated with pain, weakness, shoulder dysfunction and kinesiophobia. The management could be surgery or nonsurgical options such as medical treatment, education, activity modifications and physiotherapy. However, none of this interventions was found best additionally 30% of individuals do not report significant improvement. Physical activity is defined as any body movement produced by skeletal muscles that requires a certain amount of energy expenditure. Regular physical activity is proven to help prevent and manage many diseases such as heart disease, stroke, several cancers, diabetes, hypertension and obesity. Beyond these people, doing physical activity have better mental health, emotional wellbeing, quality of life and lower rates of mental illness. Additionally, physical activity and exercise applications are used as an alternative method to reduce the severity and frequency of pain in patients with chronic pain.

Physical activity is defined as any body movement produced by skeletal muscles that requires a certain amount of energy expenditure. Investigators reviewed the literature, investigators could not find any randomized controlled trial on the effectiveness of physical activity in studies conducted with patients with RCRSP. Investigators hypothesized that adding physical activity to the treatment of RCRSP would make a significant difference. Therefore, the aim of this study was to investigate the effect of physical activity applied in addition to supervised exercise on pain, functional status and quality of life in patients with RCRSP. This study was prospective, randomized controlled; assessor-blinded trial was performed to compare the effectiveness of physical activity in addition to supervised exercise in patients with RCRSP. According to the power analysis result, 46 patients were randomized into two groups(Treatment Group=23, Control Group=23).The Physical Activity Group (PAG) was included in an exercise program consisting of supervised exercise and physical activity (30 minutes of moderate-intensity walking). The Control Group (CG) was included in the program consisting of supervised exercises only. The treatment lasted for a total of 6 weeks. The primary outcome was Numeric Pain Rating Scale (NPRS)-activity and secondary outcomes were Numeric Pain Rating Scale (NPRS)-night The American Shoulder and Elbow Surgeons Standardized Shoulder Assessment (ASES), Quick Disabilities of The Arm, Shoulder and Hand Questionnaire (Quick DASH), Rotator Cuff Quality of Life (RC-QOL) Western-Ontario Rotator Cuff Index (WORC) and Global Rate of Changes (GRC) scores.

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, Outcomes Assessor)

入排标准

年龄范围
40 Years 至 —(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Subject age of more than 40 years
  • Having at least 3 months of unilateral shoulder pain
  • Presence of painful arc
  • Positive Hawkins Kennedy test or positive Neer sign
  • Painful shoulder abduction and external rotation with resistance
  • Absence of radiological findings of fracture in the humeral greater tubercle or glenoid cavity
  • Obtaining informed written consent

排除标准

  • Having a massive rotator cuff tear (confirmed with Magnetic Resonance (MR) and positive lag sign)
  • History of trauma related to onset of symptoms
  • Having undergone surgery on the same shoulder
  • Frozen shoulder
  • Symptomatic cervical spine pathology
  • Shoulder instability
  • Presence of shoulder problems caused by systemic diseases, neurological disorders
  • Having psychological, emotional or cognitive problems
  • Previous shoulder surgery and steroid injections
  • Engagement of regular physical activity

结局指标

主要结局

Numeric Pain Rating Scale (NPRS)-activity

时间窗: change from baseline NPRS at 6 week

The pain will be measured at activity using a NPRS. Patients are asked to rate their pain ranging from 0 to 10 (0: no pain, 10: the worst pain imaginable)

次要结局

  • Numeric Pain Rating Scale (NPRS)-night(change from baseline NPRS at 6 week)
  • The American Shoulder and Elbow Surgeons Standardized Shoulder Assessment (ASES)(change from baseline ASES score at 6 week)
  • Quick Disabilities of The Arm, Shoulder and Hand Questionnaire (Quick DASH)(change from baseline Quick DASH score at 6 week)
  • Rotator Cuff Quality of Life (RC-QOL)(change from baseline RC-QOL score at 6 week)
  • Western-Ontario Rotator Cuff Index (WORC)(change from baseline WORC score at 6 week)
  • Global Rate of Changes (GRC)(change from baseline GRC score at 6 week)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Derya Celik

Professor

Istanbul University

研究点 (1)

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