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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT04242381
Other study ID # HNEAH-KAEK 2016/269
Secondary ID
Status Completed
Phase N/A
First received
Last updated
Start date January 1, 2016
Est. completion date February 1, 2017

Study information

Verified date January 2020
Source Kars State Hospital
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

We aimed to investigate the effect of kinesiotaping on pain, functionality and ultrasound parameters in patients with shoulder impingement syndrome (SIS).


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.


Recruitment information / eligibility

Status Completed
Enrollment 75
Est. completion date February 1, 2017
Est. primary completion date January 1, 2017
Accepts healthy volunteers No
Gender All
Age group 45 Years to 70 Years
Eligibility 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 Design


Intervention

Other:
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)
Exercise treatment
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 Kinesio taping application
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

Locations

Country Name City State
Turkey Haydarpasa Numune Hospital Istanbul

Sponsors (1)

Lead Sponsor Collaborator
Kars State Hospital

Country where clinical trial is conducted

Turkey, 

Outcome

Type Measure Description Time frame Safety issue
Primary 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. 4 weeks
Primary 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. 4 weeks
Primary Joint range of motion measurements Flexion (FLX), abduction (ABD), internal rotation (IR) and external rotation (ER) were measured using a goniometer (saehan goniometer - plastic). 4 weeks
Primary 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 4 weeks
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