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Kinesio Taping Compared to Exercise Intervention for Round Shoulder Subjects With Impingement Syndrome

Primary Purpose

Shoulder Impingement Syndrome (SIS); Round Shoulder Posture (RSP)

Status
Completed
Phase
Not Applicable
Locations
Taiwan
Study Type
Interventional
Intervention
kinesio taping
exercise
Sponsored by
National Taiwan University Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Shoulder Impingement Syndrome (SIS); Round Shoulder Posture (RSP) focused on measuring Shoulder impingement syndrome, Kinesio tape, Round shoulder posture

Eligibility Criteria

20 Years - 75 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion criteria:

  1. subjects age between 20 and 75
  2. Diagnosed with shoulder impingement syndrome
  3. 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:

  1. Shoulder pain onset due to trauma
  2. A history of shoulder fractures or dislocation
  3. Cervical radiculopathy
  4. Degenerative joint disease of the shoulder
  5. Surgical interventions on the shoulder
  6. Inflammatory arthropathy

Sites / Locations

  • National Taiwan University Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Kinesio taping

Exercise

Arm Description

subject with shoulder impingement syndrome

subject with shoulder impingement syndrome

Outcomes

Primary Outcome Measures

Length of the pectoralis minor
The Pectoralis minor index (PMI) is calculated by dividing the resting muscle length by the subject's height and multiplying by 100.
Acromial distance (AD)
Acromial distance is defined as the distance from table to border of lateral-inferior acromion and measured in centimeter.
Posterior and anterior shoulder tightness
Flexibility of the posterior and anterior shoulder tissues, measured in degree
Distance of scapular medial border
The distance from the root of the spine (ROS) and the inferior angle (INF) of the scapula to the thoracic wall in millimeter respectively
Self-reported flexilevel scale of shoulder function (FLEX-SF)
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.
Pain score
Severity of pain is measured by Visual Analogue Scale, providing a range of scores from 0-10.

Secondary Outcome Measures

Full Information

First Posted
January 11, 2018
Last Updated
June 18, 2019
Sponsor
National Taiwan University Hospital
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1. Study Identification

Unique Protocol Identification Number
NCT03413488
Brief Title
Kinesio Taping Compared to Exercise Intervention for Round Shoulder Subjects With Impingement Syndrome
Official Title
Kinesio Taping Compared to Exercise Intervention for Round Shoulder Subjects With Impingement Syndrome
Study Type
Interventional

2. Study Status

Record Verification Date
February 2019
Overall Recruitment Status
Completed
Study Start Date
January 16, 2018 (Actual)
Primary Completion Date
December 14, 2018 (Actual)
Study Completion Date
December 18, 2018 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
National Taiwan University Hospital

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

Brief Summary
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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Shoulder Impingement Syndrome (SIS); Round Shoulder Posture (RSP)
Keywords
Shoulder impingement syndrome, Kinesio tape, Round shoulder posture

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Investigator
Allocation
Randomized
Enrollment
40 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Kinesio taping
Arm Type
Experimental
Arm Description
subject with shoulder impingement syndrome
Arm Title
Exercise
Arm Type
Active Comparator
Arm Description
subject with shoulder impingement syndrome
Intervention Type
Other
Intervention Name(s)
kinesio taping
Intervention Description
Apply exercise and kinesio taping for intervention
Intervention Type
Other
Intervention Name(s)
exercise
Intervention Description
Apply only exercise intervention
Primary Outcome Measure Information:
Title
Length of the pectoralis minor
Description
The Pectoralis minor index (PMI) is calculated by dividing the resting muscle length by the subject's height and multiplying by 100.
Time Frame
1 year
Title
Acromial distance (AD)
Description
Acromial distance is defined as the distance from table to border of lateral-inferior acromion and measured in centimeter.
Time Frame
1 year
Title
Posterior and anterior shoulder tightness
Description
Flexibility of the posterior and anterior shoulder tissues, measured in degree
Time Frame
1 year
Title
Distance of scapular medial border
Description
The distance from the root of the spine (ROS) and the inferior angle (INF) of the scapula to the thoracic wall in millimeter respectively
Time Frame
1 year
Title
Self-reported flexilevel scale of shoulder function (FLEX-SF)
Description
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.
Time Frame
1 year
Title
Pain score
Description
Severity of pain is measured by Visual Analogue Scale, providing a range of scores from 0-10.
Time Frame
1 year

10. Eligibility

Sex
All
Minimum Age & Unit of Time
20 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Jing-Lan Yang
Organizational Affiliation
National Taiwan University Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
National Taiwan University Hospital
City
Taipei
Country
Taiwan

12. IPD Sharing Statement

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Kinesio Taping Compared to Exercise Intervention for Round Shoulder Subjects With Impingement Syndrome

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