Brief Summary

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.

Trial Health

At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date

Enrollment

150

participants targeted

Target at P75+ for not_applicable

Timeline

Completed

Started Apr 2018

Typical duration for not_applicable

Geographic Reach

1 country

1 active site

Status

unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

2.8 years study duration

Study Start

First participant enrolled

April 1, 2018

Completed

1.8 years until next milestone

First Submitted

Initial submission to the registry

January 14, 2020

Completed

13 days until next milestone

First Posted

Study publicly available on registry

January 27, 2020

Completed

7 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 2, 2020

Completed

4 months until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2021

Completed

Last Updated

December 24, 2020

Status Verified

December 1, 2020

Enrollment Period

2.4 years

First QC Date

January 14, 2020

Last Update Submit

December 23, 2020

Conditions

Shoulder Impingement Prehabilitation Rehabilitation

Outcome Measures

Primary Outcomes (7)

Shoulder External Rotation
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.
12 months
Shoulder Internal Rotation
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.
12 months
Shoulder Abduction Range
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.
12 months
Shoulder Flexion
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.
12 months
Reaching Up Behind the Back
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.
12 months
Reaching Down Behind the Neck
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.
12 months
Shoulder pain and Disability Index Urdu version
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
12 months

Secondary Outcomes (1)

Subject feed back questions
12 months