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临床试验/NCT04747938
NCT04747938已完成不适用

Treating Frozen Shoulder With Integrative Medicine Approach by the Energy Accumulator - a Prospective Clinical Trial

Chinese University of Hong Kong0 个研究点目标入组 38 人开始时间: 2014年9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
38
主要终点
Short Form-12 (SF-12)

研究概览

简要总结

Frozen shoulder is a painful and disabling disorder of unclear cause, affecting middle-age people after their 5th decades. They suffer from annoying pain and limited shoulder mobility. Energy Accumulator provides a better way of relief through an integrative medicine concept.

详细描述

Frozen shoulder is common among middle-aged persons in the 5th and 6th decades. The pain can be acute or chronic. Patients feel stiffness over the shoulder, shown by restriction in range of motion. The etiology includes trauma, cervical disc degeneration, physical strain, psychosocial problems and even genetic factors. The predisposing factors include immobilization of the arm for a long time, rotator cuff or biceps tendinitis, tenosynovitis of the long head of the biceps, congenital deformity of the shoulder girdle, scapula-costal cementing, ligamentous injury, osteoarthritis, muscular fibrosis or nutritional deficiencies. The pathology is unclear but it is widely believed that it is related to inflammation in the joint and surrounding soft tissues which lead to fibrosis. Frozen Shoulder can be divided into Primary Frozen Shoulder which occurs spontaneously without other diseases; and Secondary Frozen Shoulder is associated with joint diseases, such as osteoarthritis or fractures.

UKFROST was a multi-centre randomized clinical trial comparing 3 parallel groups (arms) of frozen shoulder patients treated 1) under anaesthesia + steroid injection 2) under anaesthesia + arthoscopy, and 3) physiotherapy + steriod injection..The large-scale study proves physiotherapy program beneficial to frozen shoulder patients, and, the effectiveness might further improve by introducing East-Meets-West component - Chinese Medicine.

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 (Participant)

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

入选标准

  • male or female gender with age between 40-65
  • affect one shoulder only
  • onset is more than 3 months at the time of inclusion into the study

排除标准

  • unstable medical conditions
  • unstable mental state
  • have skin lesion over the shoulder
  • skin sensitivity to heat
  • pregnant or under lactation
  • could not comply with heat treatment of the shoulder.

结局指标

主要结局

Short Form-12 (SF-12)

时间窗: 4 weeks

SF-12 is a self-reported outcome measure assessing the impact of health on an individual's everyday life. Min 0 Max 100. The higher scores the better outcome.

Visual Analogue Scale (10-point Likert scale)

时间窗: 4 weeks

A pain scale containing integers between min 0 and max 10. The higher scale the better outcome (less pain)

Oxford Shoulder Score (OSS)

时间窗: 4 weeks

12-item patient-reported patient reported outcome specifically designed and developed for assessing outcomes of shoulder surgery e.g. for assessing the impact on patients' quality of life of degenerative conditions such as arthritis and rotator cuff problems. Min 0 Max 48. The higher score the better outcome.

Shoulder Pain and Disability Index (SPADI)

时间窗: 4 weeks

(SPADI) is a self-administered questionnaire that consists of two dimensions, one for pain and the other for functional activities. Min 0 Max 100. The lower the better outcome.

次要结局

未报告次要终点

研究者

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

Dr. Ho Ki Wai

Clinical Professional Consultant

Chinese University of Hong Kong

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