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Dynamic Taping in Symptomatic Rotator Cuff Tendinopathy

Primary Purpose

Rotator Cuff Tendinosis

Status
Completed
Phase
Not Applicable
Locations
Turkey
Study Type
Interventional
Intervention
Dynamic taping
Kinesio taping
Physiotherapy and Rehabilitation
Sponsored by
Muğla Sıtkı Koçman University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Rotator Cuff Tendinosis focused on measuring Rotatory cuff tendinopathy, Acromiohumeral distance, Dynamic taping, Kinesiotaping, Proprioception, Shoulder pain, Rehabilitation

Eligibility Criteria

18 Years - 65 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • Those with a diagnosis of RCT
  • Those with subacromial pain
  • At least two of the three impingement tests are positive (empty-can test, Hawkins-Kennedy test, modified Neer test)
  • 18-65 years old

Exclusion Criteria:

  • Those with open wounds at the taping area
  • Those who have allergic reactions to taping
  • Those who have had shoulder surgery before
  • Those with total rotator cuff tendon rupture
  • Those with a history of fractures in the upper extremity or glenohumeral joint subluxation -- Presence of adhesive capsulitis (those with more than passive shoulder joint motion loss 70%)
  • Presence of congenital or acquired deformity involving the upper extremity
  • Those with rheumatic or neurologic disease
  • Those with cervical radiculopathy
  • Those with a history of neoplasm or cognitive impairment (MMSE<24)
  • Those who received corticosteroid injection to the shoulder region in the last 3 months
  • Those who received physiotherapy treatment in the last 3 months

Sites / Locations

  • Muğla Sıtkı Koçman University

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Active Comparator

Active Comparator

Other

Arm Label

intervention group 1

intervention group 2

Control group

Arm Description

dynamic taping and standard rehabilitation program

Kinesio taping and standard rehabilitation program

No taping on shoulder, only standard rehabilitation program

Outcomes

Primary Outcome Measures

Acromiohumeral Distance (AHD)
Measurement of the distance between the humeral head and the inferior acromion by ultrasound to determine the subacromial space

Secondary Outcome Measures

Proprioception
Measurement with digital inclinometer with active reposition repetition method in shoulder flexion of 30 and 60 degrees
Muscle Strength
shoulder muscle strength measurement (flexion, abduction, internal and external rotation) with a manual dynamometer
Shoulder Range of Motion
Shoulder range of motion (painless and full) measurement (flexion, abduction, internal and external rotation)
Lateral Scapular Slide Test
Background: The Lateral Scapular Slide Test is a static test used in clinical settings to assess medio-lateral inferior angle displacement and scapular asymmetry at three different degrees of shoulder abduction.
Timed Functional Arm and Shoulder Test
The test includes 3 steps. 1) Hand to head and back: this test is timed for 30 seconds. Each time the patient touches the back of his or her head, it counts as 1 repetition. 2) Wall wash outward and inward: this test is timed for 60 seconds in each direction. 3) Gallon-jug lift: this test is timed for 30 seconds. Starting counter height should be 36 inches, and the shelf should be 20 inches above the counter (56 inches off the floor). Begin with a full gallon jug on the counter. Lift the jug to touch the shelf and return to start. Every time the jug touches the shelf, it counts as 1 repetition. Record the score.
The Disabilities of the Arm, Shoulder and Hand (DASH)
DASH questionnaire is a 30-item questionnaire that looks at the ability of a patient to perform certain upper extremity activities. This questionnaire is a self-report questionnaire that patients can rate difficulty and interference with daily life on a 5 point Likert scale. In DASH higher scores indicate a greater level of disability and severity, whereas, lower scores indicate a lower level of disability. The score ranges from 0 (no disability) to 100 (most severe disability).
Western Ontario Rotator Cuff (WORC) Index
the WORC Index, is a disease-specific quality of life questionnaire, evaluating the change in symptoms and functional ability, specific to a RC tendinopathy. Each question uses a visual analogue scale (VAS) - which is a straight line, representing a 100-point scale, ranging from 0-100. The maximum score (21items) is 2100 (worst possible symptoms). Zero (0) represents no symptoms at all. To make the final score more clinically friendly, some minor math is involved. The score can be reported as a percentage by subtracting the total from 2100, dividing by 2100, and multiplying by 100. This give an overall percentage. Total final WORC scores can, therefore, range from 0% ( lowest functional status level) to 100% (the highest functional status).

Full Information

First Posted
August 19, 2021
Last Updated
August 25, 2021
Sponsor
Muğla Sıtkı Koçman University
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1. Study Identification

Unique Protocol Identification Number
NCT05029544
Brief Title
Dynamic Taping in Symptomatic Rotator Cuff Tendinopathy
Official Title
Comparison of Effects of Kinesio Taping and Dynamic Taping Added to a Rehabilitation Programme for Patients With Symptomatic Rotator Cuff Tendinopathy: A Randomised Controlled Trial
Study Type
Interventional

2. Study Status

Record Verification Date
August 2021
Overall Recruitment Status
Completed
Study Start Date
March 1, 2021 (Actual)
Primary Completion Date
June 12, 2021 (Actual)
Study Completion Date
August 18, 2021 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Muğla Sıtkı Koçman University

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
This study was conducted to compare the efficacy of two different therapeutic bands in symptomatic rotator cuff tendinopathy. One of the tapes was kinesio tape and the other was dynamic tape. The study was in a parallel group randomized controlled trial design.
Detailed Description
This study was planned to compare the effectiveness of dynamic taping and kinesio taping combined with a rehabilitation program on the symptomatic shoulder in patients with symptomatic rotator cuff tendinopathy (RCT). The study was carried out on 60 patients who applied to Muğla Training and Research Hospital Physical Therapy and Rehabilitation outpatient clinic with symptoms of RCT. The patients were divided into 3 groups by randomization method. Dynamic taping was applied to the symptomatic shoulder in the first group and kinesio taping was performed in the second group. The third group was the control group and no taping was done. A standard rehabilitation program was applied for the individuals in the whole group. Evaluations were made before and after treatment (6 weeks). Evaluation parameters were acromiohumeral distance (primary outcome), shoulder joint range of motion, muscle strength, proprioception measurements, and function evaluations. The acromiohumeral distance was measured by the radiologist, and all other measurements and treatments were performed by the physiotherapist. Standard goniometer was used for shoulder joint range of motion measurement, manual muscle dynamometer was used for muscle strength measurement, and digital inclinometer was used for proprioception measurement. Timed arm-shoulder function test was performed for function evaluation. The arm, shoulder, and hand disability (DASH) questionnaire and the Western Ontario Rotator Cuff Index (WORC) were used for the self-function report. The data obtained from the research will be analyzed using the SPSS program. Statistical significance level will be accepted as p<0.05. In the statistical difference analysis between groups, one-way ANOVA test will be used for parametric data and Kruskal-Wallis test will be used for non-parametric data.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Rotator Cuff Tendinosis
Keywords
Rotatory cuff tendinopathy, Acromiohumeral distance, Dynamic taping, Kinesiotaping, Proprioception, Shoulder pain, Rehabilitation

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Investigator
Masking Description
Only the investigator who performed the acromiohumeral distance measurements was blinded.
Allocation
Randomized
Enrollment
60 (Actual)

8. Arms, Groups, and Interventions

Arm Title
intervention group 1
Arm Type
Active Comparator
Arm Description
dynamic taping and standard rehabilitation program
Arm Title
intervention group 2
Arm Type
Active Comparator
Arm Description
Kinesio taping and standard rehabilitation program
Arm Title
Control group
Arm Type
Other
Arm Description
No taping on shoulder, only standard rehabilitation program
Intervention Type
Other
Intervention Name(s)
Dynamic taping
Intervention Description
The intervention of this experimental study was therapeutic taping (dynamic tape) on the symptomatic shoulders of the participants.
Intervention Type
Other
Intervention Name(s)
Kinesio taping
Intervention Description
The intervention of this experimental study was therapeutic taping (kinesio tape) on the symptomatic shoulders of the participants.
Intervention Type
Other
Intervention Name(s)
Physiotherapy and Rehabilitation
Intervention Description
exercise, manuel therapy, mobilization, massage, sensorimotor control
Primary Outcome Measure Information:
Title
Acromiohumeral Distance (AHD)
Description
Measurement of the distance between the humeral head and the inferior acromion by ultrasound to determine the subacromial space
Time Frame
Change in acromiohumeral distance at 6 week
Secondary Outcome Measure Information:
Title
Proprioception
Description
Measurement with digital inclinometer with active reposition repetition method in shoulder flexion of 30 and 60 degrees
Time Frame
Change in proprioception at 6 week
Title
Muscle Strength
Description
shoulder muscle strength measurement (flexion, abduction, internal and external rotation) with a manual dynamometer
Time Frame
Change in shoulder muscle strength at 6 week
Title
Shoulder Range of Motion
Description
Shoulder range of motion (painless and full) measurement (flexion, abduction, internal and external rotation)
Time Frame
Change in shoulder range of motion at 6 week
Title
Lateral Scapular Slide Test
Description
Background: The Lateral Scapular Slide Test is a static test used in clinical settings to assess medio-lateral inferior angle displacement and scapular asymmetry at three different degrees of shoulder abduction.
Time Frame
Change in scapular position at 6 week
Title
Timed Functional Arm and Shoulder Test
Description
The test includes 3 steps. 1) Hand to head and back: this test is timed for 30 seconds. Each time the patient touches the back of his or her head, it counts as 1 repetition. 2) Wall wash outward and inward: this test is timed for 60 seconds in each direction. 3) Gallon-jug lift: this test is timed for 30 seconds. Starting counter height should be 36 inches, and the shelf should be 20 inches above the counter (56 inches off the floor). Begin with a full gallon jug on the counter. Lift the jug to touch the shelf and return to start. Every time the jug touches the shelf, it counts as 1 repetition. Record the score.
Time Frame
Change in shoulder function at 6 week
Title
The Disabilities of the Arm, Shoulder and Hand (DASH)
Description
DASH questionnaire is a 30-item questionnaire that looks at the ability of a patient to perform certain upper extremity activities. This questionnaire is a self-report questionnaire that patients can rate difficulty and interference with daily life on a 5 point Likert scale. In DASH higher scores indicate a greater level of disability and severity, whereas, lower scores indicate a lower level of disability. The score ranges from 0 (no disability) to 100 (most severe disability).
Time Frame
Change in DASH scores at 6 week
Title
Western Ontario Rotator Cuff (WORC) Index
Description
the WORC Index, is a disease-specific quality of life questionnaire, evaluating the change in symptoms and functional ability, specific to a RC tendinopathy. Each question uses a visual analogue scale (VAS) - which is a straight line, representing a 100-point scale, ranging from 0-100. The maximum score (21items) is 2100 (worst possible symptoms). Zero (0) represents no symptoms at all. To make the final score more clinically friendly, some minor math is involved. The score can be reported as a percentage by subtracting the total from 2100, dividing by 2100, and multiplying by 100. This give an overall percentage. Total final WORC scores can, therefore, range from 0% ( lowest functional status level) to 100% (the highest functional status).
Time Frame
Change in WORC scores at 6 week

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Those with a diagnosis of RCT Those with subacromial pain At least two of the three impingement tests are positive (empty-can test, Hawkins-Kennedy test, modified Neer test) 18-65 years old Exclusion Criteria: Those with open wounds at the taping area Those who have allergic reactions to taping Those who have had shoulder surgery before Those with total rotator cuff tendon rupture Those with a history of fractures in the upper extremity or glenohumeral joint subluxation -- Presence of adhesive capsulitis (those with more than passive shoulder joint motion loss 70%) Presence of congenital or acquired deformity involving the upper extremity Those with rheumatic or neurologic disease Those with cervical radiculopathy Those with a history of neoplasm or cognitive impairment (MMSE<24) Those who received corticosteroid injection to the shoulder region in the last 3 months Those who received physiotherapy treatment in the last 3 months
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Kılıçhan Bayar, Prof
Organizational Affiliation
Muğla Sıtkı Koçman University
Official's Role
Study Chair
Facility Information:
Facility Name
Muğla Sıtkı Koçman University
City
Muğla
Country
Turkey

12. IPD Sharing Statement

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Dynamic Taping in Symptomatic Rotator Cuff Tendinopathy

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