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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT05029544
Other study ID # interventional
Secondary ID
Status Completed
Phase N/A
First received
Last updated
Start date March 1, 2021
Est. completion date August 18, 2021

Study information

Verified date August 2021
Source Mugla Sitki Koçman University
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.


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.


Recruitment information / eligibility

Status Completed
Enrollment 60
Est. completion date August 18, 2021
Est. primary completion date June 12, 2021
Accepts healthy volunteers No
Gender All
Age group 18 Years to 65 Years
Eligibility 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

Study Design


Intervention

Other:
Dynamic taping
The intervention of this experimental study was therapeutic taping (dynamic tape) on the symptomatic shoulders of the participants.
Kinesio taping
The intervention of this experimental study was therapeutic taping (kinesio tape) on the symptomatic shoulders of the participants.
Physiotherapy and Rehabilitation
exercise, manuel therapy, mobilization, massage, sensorimotor control

Locations

Country Name City State
Turkey Mugla Sitki Koçman University Mugla

Sponsors (1)

Lead Sponsor Collaborator
Mugla Sitki Koçman University

Country where clinical trial is conducted

Turkey, 

Outcome

Type Measure Description Time frame Safety issue
Primary Acromiohumeral Distance (AHD) Measurement of the distance between the humeral head and the inferior acromion by ultrasound to determine the subacromial space Change in acromiohumeral distance at 6 week
Secondary Proprioception Measurement with digital inclinometer with active reposition repetition method in shoulder flexion of 30 and 60 degrees Change in proprioception at 6 week
Secondary Muscle Strength shoulder muscle strength measurement (flexion, abduction, internal and external rotation) with a manual dynamometer Change in shoulder muscle strength at 6 week
Secondary Shoulder Range of Motion Shoulder range of motion (painless and full) measurement (flexion, abduction, internal and external rotation) Change in shoulder range of motion at 6 week
Secondary 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. Change in scapular position at 6 week
Secondary 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. Change in shoulder function at 6 week
Secondary 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). Change in DASH scores at 6 week
Secondary 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). Change in WORC scores at 6 week
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