- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04242381
Short Term Effect of Kinesiotaping In Patients With Shoulder Impingement Syndrome
Short Term Effect Of Kinesiotaping on Pain, Functionality, and Ultrasound Parameters In Patients With Shoulder Impingement Syndrome: A Randomized Sham-Controlled Study
Study Overview
Status
Conditions
Detailed Description
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
-
Istanbul, Turkey
- Haydarpasa Numune Hospital
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
- at least three positive results in the Hawkins-Kennedy, Neer, empty can, drop-arm, and lift-off tests
- magnetic resonance imaging findings
- age between 45 and 70 years
Exclusion Criteria:
- Patients who received physical therapy for the shoulder region within the past three months or those with a history of injections to the shoulder joint,
- cervical pathologies,
- clinical conditions accompanied by neuromotor or sensory dysfunction,
- history of malignancy,
- pregnancies,
- partial or total rupture in the supraspinatus tendon,
- adhesive capsulitis,
- diabetes or chronic liver, or kidney failure
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: Group 1: Cold application, Kinesiotaping treatment
Cold application: At the beginning of each treatment session, gel ice packs were wrapped in a damp towel and applied to the patients' shoulder joints for 20 minutes. Kinesiotaping application: KT was applied to the deltoid muscle using the inhibition and mechanical correction technique and to the supraspinatus muscle using the inhibition technique (2 sessions with a 5-day interval). |
At the beginning of each treatment session, gel ice packs were wrapped in a damp towel and applied to the patients' shoulder joints for 20 minutes.
KT was applied to the deltoid muscle using the inhibition and mechanical correction technique and to the supraspinatus muscle using the inhibition technique (2 sessions with a 5-day interval)
|
|
Experimental: Group 2: Cold application, EX treatment
EX treatment was administered for 10 days with 3 sessions/day.
A triphasic exercise program was administered to the patients.
Exercise was administered twice a week under supervision; however, the patients were advised to exercise at home on the other days with 20 repetitions of each exercise.
The patients were followed up via telephone to make sure they were adhering to their exercise programs.
|
At the beginning of each treatment session, gel ice packs were wrapped in a damp towel and applied to the patients' shoulder joints for 20 minutes.
EX treatment was administered for 10 days with 3 sessions/day.
A triphasic exercise program was administered to the patients.
Before starting the exercise program, the patients were instructed to not perform the movements exceeding 90° overhead.
The exercise program was initiated using codman pendulum, passive joint motion range (with a 1-m stick), and posterior capsule stretching exercise.
Shoulder wheel, finger ladder, and shoulder strengthening exercise with theraband were added to the exercise programs of patients with full or near total range of motion and pain relief.
Exercise was administered twice a week under supervision; however, the patients were advised to exercise at home on the other days with 20 repetitions of each exercise.
The patients were followed up via telephone to make sure they were adhering to their exercise programs.
|
|
Sham Comparator: Group 3: Cold application, sham-KT treatment
Sham-KT was applied in 10 cm I-shaped stripes on the sagittal plane over the acromioclavicular joint without stretching and on the transverse plane distal to the deltoid area.
The kinesiotape was applied twice for five days with 2-day intervals
|
At the beginning of each treatment session, gel ice packs were wrapped in a damp towel and applied to the patients' shoulder joints for 20 minutes.
Sham-KT was applied in 10 cm I-shaped stripes on the sagittal plane over the acromioclavicular joint without stretching and on the transverse plane distal to the deltoid area.
The kinesiotape was applied twice for five days with 2-day intervals
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Pain Level
Time Frame: 4 weeks
|
The severity of shoulder pain (resting, activity, and night pain) in the patients was evaluated through the VAS score.
A VAS score of 0 represented no pain, whereas a score of 10 represented the most severe pain; the patients were asked to mark the average severity of the pain they felt during the past week and the marked point was measured using a centimeter ruler and recorded.
|
4 weeks
|
|
Functional Status
Time Frame: 4 weeks
|
Quick-Disabilities of the Arm, Shoulder and Hand (Q-DASH) questionnaire: This questionnaire comprises three sections.
The first section comprises 30 items: 21 items assess the patient's difficulties in performing daily activities, 5 assess symptoms (pain, activity-related pain, tingling, stiffness, and weakness), and each of the remaining 4 items assesses social function, work, sleep, and self-confidence.
All items are rated on a 5-point Likert-type scale (1, no difficulty; 2, mild difficulty; 3, moderate difficulty; 4, extreme difficulty; 5, cannot perform at all).
The total score possible through this questionnaire ranges from 0 to 100 (0, no disability; 100, maximum disability).
Furthermore, Turkish reliability and validity have been performed for this questionnaire.
|
4 weeks
|
|
Joint range of motion measurements
Time Frame: 4 weeks
|
Flexion (FLX), abduction (ABD), internal rotation (IR) and external rotation (ER) were measured using a goniometer (saehan gonıometer - plastıc).
|
4 weeks
|
|
Ultrasonography
Time Frame: 4 weeks
|
US was performed using a 7.5-mHz linear probe in the B mode (Mindray-China).
Supraspinatus tendon (SsT) thickness was measured at three different points (10, 15, and 20 mm) lateral to the tendon after identifying the biceps tendon in the transverse section and the average of measurements was recorded.
Acromiohumeral distance (AHD) was assessed by linearly measuring the distance between the inferior of the acromion from the anterior of the shoulder and the superior of the humeral head
|
4 weeks
|
Collaborators and Investigators
Sponsor
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- HNEAH-KAEK 2016/269
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
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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