- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03413488
Kinesio Taping Compared to Exercise Intervention for Round Shoulder Subjects With Impingement Syndrome
June 18, 2019 updated by: National Taiwan University Hospital
To compare the effect between the exercise intervention (strengthening exercise and stretching exercise) and exercise intervention with taping on decreasing round shoulder posture and improving symptoms in subjects with shoulder impingement syndrome/round shoulder syndrome.
Study Overview
Status
Completed
Intervention / Treatment
Detailed Description
Background: Poor posture and abnormal scapular kinematics have been suggested as possible primary factors in developing Shoulder impingement syndrome (SIS) and also as secondary observed phenomena of SIS.
Round shoulder posture (RSP) is major and common posture contributing to increase the potential for subacromial impingement or exaggerate the symptoms of SIS.
Objective: To compare the effect between the exercise intervention (strengthening exercise and stretching exercise) and exercise intervention with taping on decreasing RSP and improving symptoms in subjects with SIS/RSP.
Methods: Forty subjects with impingement age between 20 and 75 are recruited and measured on acromial distance, pectoralis minor index (PMI), posterior and anterior shoulder tightness, distance of scapular medial border, pain score and flexilevel scale of shoulder function (FLEX-SF).
Clinical significance: Shoulder impingement syndrome (SIS) have been identified as the majority of reported shoulder complaints.
The project will provide an effective intervention for subjects with SIS/RSP.
Study Type
Interventional
Enrollment (Actual)
40
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
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Taipei, Taiwan
- National Taiwan University Hospital
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
20 years to 75 years (ADULT, OLDER_ADULT)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
Inclusion criteria:
- subjects age between 20 and 75
- Diagnosed with shoulder impingement syndrome
- At least three positive of five tests, including Neer's test, Hawkin's test, Empty can test, tenderness in tendon of rotator cuff
Exclusion criteria:
- Shoulder pain onset due to trauma
- A history of shoulder fractures or dislocation
- Cervical radiculopathy
- Degenerative joint disease of the shoulder
- Surgical interventions on the shoulder
- Inflammatory arthropathy
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: TREATMENT
- Allocation: RANDOMIZED
- Interventional Model: PARALLEL
- Masking: SINGLE
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
EXPERIMENTAL: Kinesio taping
subject with shoulder impingement syndrome
|
Apply exercise and kinesio taping for intervention
|
|
ACTIVE_COMPARATOR: Exercise
subject with shoulder impingement syndrome
|
Apply only exercise intervention
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Length of the pectoralis minor
Time Frame: 1 year
|
The Pectoralis minor index (PMI) is calculated by dividing the resting muscle length by the subject's height and multiplying by 100.
|
1 year
|
|
Acromial distance (AD)
Time Frame: 1 year
|
Acromial distance is defined as the distance from table to border of lateral-inferior acromion and measured in centimeter.
|
1 year
|
|
Posterior and anterior shoulder tightness
Time Frame: 1 year
|
Flexibility of the posterior and anterior shoulder tissues, measured in degree
|
1 year
|
|
Distance of scapular medial border
Time Frame: 1 year
|
The distance from the root of the spine (ROS) and the inferior angle (INF) of the scapula to the thoracic wall in millimeter respectively
|
1 year
|
|
Self-reported flexilevel scale of shoulder function (FLEX-SF)
Time Frame: 1 year
|
FLEX-SF is used to assess shoulder function and disability.
Scores will be recorded from 1, with the most limited function, to 50, without any limited function in the subject.
|
1 year
|
|
Pain score
Time Frame: 1 year
|
Severity of pain is measured by Visual Analogue Scale, providing a range of scores from 0-10.
|
1 year
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (ACTUAL)
January 16, 2018
Primary Completion (ACTUAL)
December 14, 2018
Study Completion (ACTUAL)
December 18, 2018
Study Registration Dates
First Submitted
January 11, 2018
First Submitted That Met QC Criteria
January 22, 2018
First Posted (ACTUAL)
January 29, 2018
Study Record Updates
Last Update Posted (ACTUAL)
June 20, 2019
Last Update Submitted That Met QC Criteria
June 18, 2019
Last Verified
February 1, 2019
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 201705117RIND
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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