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临床试验/NCT04242888
NCT04242888Unknown不适用

The Acute Effects of Pragmatic Manual Therapy on the Range of Motion of Shoulder Joint

Isra University2 个研究点 分布在 1 个国家目标入组 150 人开始时间: 2018年4月1日最近更新:
适应症

试验速览

阶段
不适用
入组人数
150
试验地点
2
主要终点
Shoulder External Rotation

研究概览

简要总结

Current studies on the mechanism of subacromial impingement and other shoulder pathology reveal that multiple factors are responsible for impingement. These include serratus anterior dysfunction, rotator cuff insufficiency, posterior capsular tightness, acromioclavicular joint, thoracic spine stiffness and extensibility of the pectoralis minor and subclavius muscles. Manual intervention should therefore address these issues in conjunction with the other therapies. Novel interventions have been designed pilot tested for each of these factors to produce a healing environment. The purpose of this study is to evaluate the effects of each individual factor and combination of all on the range of motion of shoulder joint in healthy subjects and subjects with a restricted range of motion of shoulder joint respectively. The subject will be allocated randomly into four groups with respect to objective 1 and each of the groups will be evaluated as a quasi-experiment design (pretest-posttest) for healthy each of 30 subjects. Beneficial intervention among the four trials and other previously reported beneficial in improving the shoulder joint range will be combined in and termed as pragmatic intervention protocols. Pragmatic interventions on subjects with the restricted range in shoulder pathology will be tested through a similar design. The effects of these interventions on the Quality of life measured through the Urdu version of Shoulder pain and disability in subjects with shoulder pathology will also be tested.

详细描述

Shoulder disorders are the 3rd commonest among musculoskeletal conditions. Its prevalence is estimated 7-26% at one point of time and 67% of the individuals experience shoulder pain once in their life. Subacromial impingements (SAIS) are the frequent diagnosis accounting for 45-65% of all shoulder disorders. It is defined as "a condition in which the tendons of the rotator cuff muscles, long head of the biceps or the subacromial bursa are entrapped between the humeral head inferiorly and anterior acromion superiorly.

Multiple researchers have studied interventions which affect the shoulder range of motions. Thoracic spine manipulation improves the shoulder range of motion. Similarly, Stretching the pectorallis minor muscles improve shoulder kinematics. Manual intervention for subscapularis, infra spinatus, and serratus anterior are non-existent to investigators' knowledge. Modification to stretch the posterior capsule in a pragmatic manner is described and recommended but trials are nonexistent. Acromioclavicular joint being the part of the scapolo-glenohumeral complex has a role to play in the kinematics of the shoulder but trials on its mobilization with respect to shoulder range of motion are not been studies. These gaps in research in relation to understanding of the mechanism of shoulder pathology and subsequent intervention are also identified but trials and interventions are non-existent.

The understanding of the complex relations of the intrinsic and extrinsic factors necessitates the development of manual therapy interventions to address the factors which are adversely affect range of motion of shoulder joint. The purpose of this research is to develop and propose manual therapy interventions for shoulder joint which can effectively address the limitations in shoulder joint ranges of motion in both healthy subjects and subjects with shoulder pathology having decrease range of motion through a series of primitive trials.

AIMES AND OBJECTIVES The primary purpose of this study is to evaluate the short term effects of Pragmatic manual interventions on range of motion of the shoulder joint in healthy individual and individuals with shoulder pathology who have restricted ranges of motion .The aims of this study are therefore to

  1. To evaluate the effects of pragmatic interventions in healthy asymptomatic subjects with respect to the changes in shoulder joint restricted range of motion
  2. To evaluate the effects of interventions in symptomatic shoulder individual with restriction in their shoulder range of motion and short term change in the shoulder related quality of life and pain MATERIAL AND METHOD A single group quasi-experimental (pretest-posttest) design will be used for all the trials in this study. It will be conducted at Helping Hand Institute of Rehabilitation Sciences, Mansehra. The study will be composed of 4 trials in the first phase on healthy subject with respect to each of the proposed pragmatic (novice) intervention consistent with the first objective and exploratory in nature. Subjects will be randomly allocated to the initial four groups. The initial 4 trials on healthy subjects are chosen since the effects of each of the proposed pragmatic interventions is not been studied but advocated. Healthy subjects with restriction in shoulder ROM are deemed appropriate since other confounding factors such as pain is absent and objectives could be achieved. In Phase 2, trial on patient with shoulder pathology will be conducted after evaluating the effects on range of motion in healthy individual. Each trial will recruit 30 subjects. subjects in trial 5 with shoulder pathology will be assessed through Urdu version of shoulder pain and disability index at baseline, after one week and 5 weeks of pragmatic interventions. A sample size of 30 for each trial ( a total of 150 subject) is deemed appropriate after a pilot trial on 5 healthy subject which produced a meaningful difference of 15 degree change in abduction, and 3 cm difference in reaching up behind the back and using standard deviation estimates from previous studies. Finally, The urdu translated and validated version of SPADI will used to measure shoulder related pain and Disability. Ethical approval will be sought from REC Isra university and Ethical committee of HHIRS. Subjects consent will be taken in writing (annex 2) and full study information will be given (annex 3). Each of Phase 1 and phase 2 of this study will be completed in 6 months (a total of 1 year) from August 2019 to August 2020.

研究设计

研究类型
Interventional
分配方式
Non Randomized
干预模型
Sequential
主要目的
Treatment
盲法
Double (Participant, Outcomes Assessor)

盲法说明

participant and outcome assessor does not know the purpose of the trial

入排标准

年龄范围
18 Years 至 60 Years(Adult)
性别
All
接受健康志愿者

入选标准

  • For trial 1-4
  • Limitation in Abduction or Internal rotation or reaching behind up or down the back
  • A score of 1 and 2 on FMS For trial 5
  • main complaint in gleno-humeral joint
  • Limitation in Range of motion of Abduction or internal rotation or external rotation or reaching up behind the back or reaching down behind down the neck , all or only one of the limitation in comparison with the unaffected joint.

排除标准

  • For trial 1-4
  • Any known pathology or deformity of the shoulder joint
  • A zero and 3 score on FMS For trial 5
  • Previous history of dislocation or fracture in shoulder
  • Severe underlying chronic medical condition
  • shoulder surgeries
  • Brachial plexus and axillary nerve injuries
  • Severe constant shoulder pain which does not fit into the inclusion criteria
  • Pain associated with shoulder swelling, redness or cysts
  • Known rheumatoid arthritis
  • Steroid injection within two weeks
  • Psychosocial yellow flags or intellectual disability

结局指标

主要结局

Shoulder External Rotation

时间窗: 12 months

The change in external rotation range will be assessed at baseline and soon after the application of intervention in each of the trial. A higher score indicate improvement. A digital inclinometer will be used for measurement.

Shoulder Abduction Range

时间窗: 12 months

The change in abduction range will be assessed at baseline and soon after the application of intervention in each of the trial.A higher score indicate improvement. A digital inclinometer will be used for measurement.

Shoulder Flexion

时间窗: 12 months

The change in Flexion range will be assessed at baseline and soon after the application of intervention in each trial. A higher score indicate improvement. A digital inclinometer will be used for measurement.

Reaching Up Behind the Back

时间窗: 12 months

The change in the distance between tip of the middle finger of one hand and the thumb of the other hand will be measured through measuring tap in each trial, as measured in functional movement screen.A lower difference between the scors indicates improvement.

Reaching Down Behind the Neck

时间窗: 12 months

the change in the distance between tip of the middle finger of one hand and the thumb of the other hand will be measured through measuring tap in each trial, as measured in functional movement screen.A lower difference between the scors indicates improvement.

Shoulder Internal Rotation

时间窗: 12 months

The change in internal rotation range will be assessed at baseline and soon after the application of in each of the trial.A higher score indicate improvement. A digital inclinometer will be used for measurement.

Shoulder pain and Disability Index Urdu version

时间窗: 12 months

Change in scores Shoulder pain and disability index Urdu version will be assessed at baseline line in subjects with shoulder pathology and at 6th week of the combined intervention protocol. Less score indicate improved pain and disability

次要结局

  • Subject feed back questions(12 months)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (2)

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