search
Back to results

Short Term Effect of Kinesiotaping In Patients With Shoulder Impingement Syndrome

Primary Purpose

Kinesiotape, Exercise, Ultrasound

Status
Completed
Phase
Not Applicable
Locations
Turkey
Study Type
Interventional
Intervention
Cold Application
Kinesiotaping Application
Exercise treatment
Sham Kinesio taping application
Sponsored by
Kars State Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Kinesiotape focused on measuring Kinesiotape, exercise, ultrasound

Eligibility Criteria

45 Years - 70 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Haydarpasa Numune Hospital

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

Experimental

Sham Comparator

Arm Label

Group 1: Cold application, Kinesiotaping treatment

Group 2: Cold application, EX treatment

Group 3: Cold application, sham-KT treatment

Arm Description

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).

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.

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

Outcomes

Primary Outcome Measures

Pain Level
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.
Functional Status
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.
Joint range of motion measurements
Flexion (FLX), abduction (ABD), internal rotation (IR) and external rotation (ER) were measured using a goniometer (saehan gonıometer - plastıc).
Ultrasonography
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

Secondary Outcome Measures

Full Information

First Posted
January 20, 2020
Last Updated
January 24, 2020
Sponsor
Kars State Hospital
search

1. Study Identification

Unique Protocol Identification Number
NCT04242381
Brief Title
Short Term Effect of Kinesiotaping In Patients With Shoulder Impingement Syndrome
Official Title
Short Term Effect Of Kinesiotaping on Pain, Functionality, and Ultrasound Parameters In Patients With Shoulder Impingement Syndrome: A Randomized Sham-Controlled Study
Study Type
Interventional

2. Study Status

Record Verification Date
January 2020
Overall Recruitment Status
Completed
Study Start Date
January 1, 2016 (Actual)
Primary Completion Date
January 1, 2017 (Actual)
Study Completion Date
February 1, 2017 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Kars State 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
We aimed to investigate the effect of kinesiotaping on pain, functionality and ultrasound parameters in patients with shoulder impingement syndrome (SIS).
Detailed Description
A total of 75 patients with SIS were randomly classified into the following three groups: kinesiotaping (KT), exercise (EX) and sham-kinesiotaping (sham-KT). Each group was underwent two weeks treatment program. The patients were then evaluated in terms of pain analyzed using the visual analog scale (VAS), joint range of motion, Quick-Disabilities of the Arm, Shoulder and Hand (Q-DASH) questionnaire before and after treatment. In addition, supraspinatus tendon (SsT) thickness and acromiohumeral distance (AHD) parameters were measured using ultrasonography (US). All parameters were measured before and after treatment.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Kinesiotape, Exercise, Ultrasound
Keywords
Kinesiotape, exercise, ultrasound

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
A Randomized Sham-Controlled Study
Masking
Investigator
Masking Description
All participants were assessed by the same clinician (F.B) at the baseline and at the two week after completing the interventions by visual analog scale (VAS), range of motion (ROM) and Disabilities of the Arm, Shoulder and Hand Questionnaire (Q-DASH). KT and sham-KT applications were made by same clinician (N.M). For ultrasnogohraphic (US) measurements, the participants were sent to a clinician (D.G.K) who was blinded to the group allocation.
Allocation
Randomized
Enrollment
75 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Group 1: Cold application, Kinesiotaping treatment
Arm Type
Experimental
Arm Description
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).
Arm Title
Group 2: Cold application, EX treatment
Arm Type
Experimental
Arm Description
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.
Arm Title
Group 3: Cold application, sham-KT treatment
Arm Type
Sham Comparator
Arm Description
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
Intervention Type
Other
Intervention Name(s)
Cold Application
Intervention Description
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.
Intervention Type
Other
Intervention Name(s)
Kinesiotaping Application
Intervention Description
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)
Intervention Type
Other
Intervention Name(s)
Exercise treatment
Intervention Description
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.
Intervention Type
Other
Intervention Name(s)
Sham Kinesio taping application
Intervention Description
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
Primary Outcome Measure Information:
Title
Pain Level
Description
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.
Time Frame
4 weeks
Title
Functional Status
Description
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.
Time Frame
4 weeks
Title
Joint range of motion measurements
Description
Flexion (FLX), abduction (ABD), internal rotation (IR) and external rotation (ER) were measured using a goniometer (saehan gonıometer - plastıc).
Time Frame
4 weeks
Title
Ultrasonography
Description
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
Time Frame
4 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
45 Years
Maximum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Facility Information:
Facility Name
Haydarpasa Numune Hospital
City
Istanbul
Country
Turkey

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

Short Term Effect of Kinesiotaping In Patients With Shoulder Impingement Syndrome

We'll reach out to this number within 24 hrs