NCT04242381

Brief Summary

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

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
75

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Jan 2016

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2016

Completed
1 year until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2017

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

February 1, 2017

Completed
3 years until next milestone

First Submitted

Initial submission to the registry

January 20, 2020

Completed
7 days until next milestone

First Posted

Study publicly available on registry

January 27, 2020

Completed
Last Updated

January 27, 2020

Status Verified

January 1, 2020

Enrollment Period

1 year

First QC Date

January 20, 2020

Last Update Submit

January 24, 2020

Conditions

Keywords

Kinesiotapeexerciseultrasound

Outcome Measures

Primary Outcomes (4)

  • 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

  • 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

  • Joint range of motion measurements

    Flexion (FLX), abduction (ABD), internal rotation (IR) and external rotation (ER) were measured using a goniometer (saehan gonıometer - plastıc).

    4 weeks

  • 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

Study Arms (3)

Group 1: Cold application, Kinesiotaping treatment

EXPERIMENTAL

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).

Other: Cold ApplicationOther: Kinesiotaping Application

Group 2: Cold application, EX treatment

EXPERIMENTAL

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.

Other: Cold ApplicationOther: Exercise treatment

Group 3: Cold application, sham-KT treatment

SHAM COMPARATOR

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

Other: Cold ApplicationOther: Sham Kinesio taping application

Interventions

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.

Group 1: Cold application, Kinesiotaping treatmentGroup 2: Cold application, EX treatmentGroup 3: Cold application, sham-KT treatment

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)

Group 1: Cold application, Kinesiotaping 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.

Group 2: Cold application, EX 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

Group 3: Cold application, sham-KT treatment

Eligibility Criteria

Age45 Years - 70 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Haydarpasa Numune Hospital

Istanbul, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Motor Activity

Condition Hierarchy (Ancestors)

Behavior

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
INVESTIGATOR
Masking Details
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.
Purpose
TREATMENT
Intervention Model
PARALLEL
Model Details: A Randomized Sham-Controlled Study
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

January 20, 2020

First Posted

January 27, 2020

Study Start

January 1, 2016

Primary Completion

January 1, 2017

Study Completion

February 1, 2017

Last Updated

January 27, 2020

Record last verified: 2020-01

Data Sharing

IPD Sharing
Will not share

Locations