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临床试验/NCT03055117
NCT03055117已完成不适用

Individual Versus Group-based Exercise Rehabilitation for Shoulder Disorders

Regional Hospital West Jutland2 个研究点 分布在 1 个国家目标入组 180 人开始时间: 2017年2月16日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
180
试验地点
2
主要终点
Disability wil be assessed by The Disabilities of the Arm, Shoulder and Hand questionnaire - shortened version (Quick DASH)

研究概览

简要总结

Degenerative shoulder disorders are frequent in the Danish population and often cause disability and sick leave. After hospital discharge patients are often referred to physiotherapy rehabilitation as part of the treatment, and it is often assumed that one-on-one sessions will yield better results than group-based sessions, because individual needs can be better meet and targeted

The project aims to evaluate the effect and cost-effectiveness of group- based exercise rehabilitation as compared to individual exercise rehabilitation in patients with degenerative shoulder disorders.

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详细描述

The study is a three-armed controlled randomized trial in which a total of 180 patients referred to the municipal rehabilitation after hospital treatment due to shoulder disorders in 6 municipalities in Region Midtjylland expected to participate. Patients will be allocated to either 1) Group-based rehabilitation 2) Individual rehabilitation or 3) Home exercise.

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 (Investigator)

入排标准

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

入选标准

  • 18 years and above, ability to speak and understand Danish and referred to physiotherapy rehabilitation after hospital conservative or surgical treatment under diagnose of rotator cuff/shoulder impingement or acromioclavicular osteoarthritis (International Classification of Diseases 10th revision [ICD-10] group M75.1-M75.8, M19.8).

排除标准

  • Influence of co-morbidity, psychiatric illness, pregnancy, fullthickness rotator cuff tear, rotator cuff repair surgery, traumatic lesion, rheumatoid arthritis, frozen shoulder, glenohumeral osteoarthritis.

结局指标

主要结局

Disability wil be assessed by The Disabilities of the Arm, Shoulder and Hand questionnaire - shortened version (Quick DASH)

时间窗: 6 monhts

Sum score 0-100

次要结局

  • Cost-effectiveness across study arms measured by the EuroQol (EQ-5D) questionnaire(6 months)
  • Pain intensity(6 months)
  • Time off work (weeks) assessed by the Danish Register of Sickness absence compensation benefits and Social transfer payments(6 months)
  • Patients impression of change of overall shoulder condition(6 months)
  • Well-being wil be assessed by the WHO-5 Well-being Index questionnaire(6 months)
  • Re-presentations after discharge from rehabilitation will be obtained by Danish National Rehabilitation(6 months)
  • Fear avoidance Beliefs and risk of chronicity the Orebro Musculoskeletal Pain Screening Questionnaire(6 months)
  • Safety will be assessed by one item from the Danish Cancer Society PREM (Barometer) Questionnaire(3 months)
  • Patient Acceptable Symptom State (PASS)(6 months)
  • Confidence will be assessed by one item from the Danish Cancer Society PREM (Barometer) Questionnaire(3 months)
  • Satisfaction will be assessed by one item from the Danish Cancer Society PREM (Barometer) Questionnaire(3 months)

研究者

发起方
Regional Hospital West Jutland
申办方类型
Other
责任方
Principal Investigator
主要研究者

David H Christiansen

Researcher

Regional Hospital West Jutland

研究点 (2)

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