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临床试验/NCT03711409
NCT03711409已完成不适用

Comparison of Soft Tissue Biased Manual Therapy and Conventional Physical Therapy on Shoulder Kinematics, Muscle Performance, Functional Impairment & Pain in Patients With Frozen Shoulder

National Yang Ming Chiao Tung University2 个研究点 分布在 1 个国家目标入组 34 人开始时间: 2018年12月25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
34
试验地点
2
主要终点
Scapulo-humeral rhythm (scapular kinematics) during functional movements

研究概览

简要总结

Adhesive capsulitis, also known as frozen shoulder (FS), is a condition characterized by the functional restriction of both active and passive shoulder motion with unremarkable glenohumeral joint radiographs findings. Shoulder pain almost exists during the whole course of frozen shoulder. Pain induces muscle spasm and causes pain-spasm-pain cycle resulting in limited range of motion, changed muscle recruitment pattern and finally influences neuromuscular control. Commonly used conservative interventions for FS patients include joint mobilization, corticosteroid injection, exercise, modality and soft tissue mobilization. Despite joint mobilization is the most commonly used manual therapy in patients with FS, the evidence level is weak and the efficacy is not superior to other conservative treatments. Soft tissue mobilization is widely used in lots of musculoskeletal conditions. The effects of soft tissue mobilization include breaking the adhesion tissue and improving range of motion, muscle strength and motor control. However, few studies have investigated the effect of soft tissue mobilization in patients with frozen shoulder. Therefore, the purpose of this study is to investigate and compare the effect of soft tissue biased manual therapy and conventional physical therapy in patients with primary FS.

详细描述

Adhesive capsulitis, also known as frozen shoulder (FS), is a condition characterized by a functional restriction of both active and passive shoulder motion with unremarkable glenohumeral joint radiographs findings. Frozen shoulder is divided into primary and secondary type. The mechanism of primary FS is still unknown and the secondary FS may accompany with shoulder injuries. The incidence of primary FS is 2 to 5.8% and the risk factors are diabetes and thyroid disease.

The course of FS is divided into four consecutive stages which are inflammation, painful, frozen and thawing phase. Shoulder pain almost exists during the whole course of frozen shoulder. The pain and discomfort of FS patients are frequently localized to the deltoid insertion and coracoid process. Pain induces muscle spasm and causes pain-spasm-pain cycle resulting in limited range of motion, changed muscle recruitment pattern and finally influences neuromuscular control.

Commonly used conservative interventions for FS patients include joint mobilization, corticosteroid injection, exercise, modality and soft tissue mobilization. Despite joint mobilization is the most commonly used manual therapy in patients with FS, the evidence level is weak and the efficacy is not superior to other conservative treatment s. Soft tissue mobilization is widely used in lots of musculoskeletal conditions. The effects of soft tissue mobilization include breaking the adhesion tissue and improving range of motion, muscle strength and motor control. However, few studies have investigated the effect of soft tissue mobilization in patients with frozen shoulder. Only one study used one-time muscle release to FS patients and investigate improvement in shoulder biomechanics, muscle strength and ROM. Therefore, the purpose of this study is to investigate and compare the effect of soft tissue biased manual therapy and conventional physical therapy for six weeks in patients with primary FS.

The study design is a pretest-posttest control group design. The investigators plan to recruit 70 patients with primary frozen shoulder and divide them into a soft tissue biased manual therapy group and a conventional physical therapy group. The sample size is determined by the previous study. It is based on a significance level of 0.05, and a power of 0.80. The outcome measures in this study include scapula kinematics, scapula position, the range of motion, muscle tone, muscle strength, pain and functional impairment.

LIBERTY™ electromagnetic tracking system (Polhemus, Colchester, VT, USA) was used to collect three-dimensional kinematic (3D) data during scaption, hand to neck and hand to back tasks at a sampling rate of 120 Hz, and the software Motion Monitor® (Innovative Sport Training, Inc., Chicago. IL. USA) was used to analyze the data. The main measurements of shoulder kinematics include scapular upward/downward rotation, internal/external rotation, and anterior/posterior tilt. A stylus was used to digitize the bony landmarks for defining the anatomical coordinate system. The methods for this measure have been described previously.

研究设计

研究类型
Interventional
分配方式
Non Randomized
干预模型
Parallel
主要目的
Treatment
盲法
None

入排标准

年龄范围
40 Years 至 70 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Primary adhesive capsulitis diagnosed by orthopaedic surgeon or physiatrist
  • Reduction in range of motion in more than two planes
  • < 30 degrees of the external rotation range of motion during shoulder abduct to 90 degree
  • No radiologic abnormality
  • Onset time more than three months
  • No night pain and resting pain

排除标准

  • History of stroke, diabetes mellitus, rheumatoid arthritis, rotator cuff tear, shoulder osteoarthritis, surgical stabilization/surgery of the shoulder, osteoporosis, or malignancies in the shoulder region

结局指标

主要结局

Scapulo-humeral rhythm (scapular kinematics) during functional movements

时间窗: Baseline and after 6-week intervention

Change from baseline of scapular kinematics to after 6 week intervention during scaption task, hand to neck task and hand to back task

次要结局

  • Dynamic stiffness (N/m) of shoulder muscles(Baseline, 3-week intervention and 6-week intervention)
  • Range of motion of shoulder joint (Goniometer)(Baseline, 3-week intervention and 6-week intervention)
  • Creep of shoulder muscles(Baseline, 3-week intervention and 6-week intervention)
  • Shoulder disability(Baseline, 3-week intervention and 6-week intervention)
  • Shoulder pain(Baseline, 3-week intervention and 6-week intervention)
  • Mechanical stress relaxation time (ms) of shoulder muscles(Baseline, 3-week intervention and 6-week intervention)
  • Muscle strength of shoulder muscles (Hand-held Dyanometer)(Baseline, 3-week intervention and 6-week intervention)
  • Scapula dyskinesia(Baseline, 3-week intervention and 6-week intervention)
  • Scapula motor control (muscle activation percentage)(Baseline and after 6-week intervention)
  • Oscillation frequency (Hz) of shoulder muscles(Baseline, 3-week intervention and 6-week intervention)

研究者

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

Yi-Fen Shih

Professor, Department of Physical Therapy and Assistive Technology, National Yang-Ming University

National Yang Ming Chiao Tung University

研究点 (2)

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