NCT06559124

Brief Summary

The aim of the study is to compare the effects of different kinesiotape applications in addition to traditional physiotherapy on shoulder pain, joint range of motion, muscle strength, functionality and kinesiophobia in patients diagnosed with shoulder impingement syndrome within and between groups. Subacromial space; At the bottom, it is the region limited by the humeral head and tuberculum major, acromion (anterior 1/3 of the acromion), coracoacromial ligament, coracoid process and acromioclavicular joint and acromioclavicular ligament. The rotator cuff muscles pass through this area and move within it. In anteroposterior radiographs taken with the shoulder in 0° abduction, the distance between the acromion and the humeral head is approximately 1.1 cm (1.0-1.5 cm). Between these two structures are the rotator cuff (mostly the supraspinatus tendon), the long head of the biceps muscle, the bursa, and the coracoacromial ligament. When incompatibility is observed between the mentioned bone structures, it causes pressure on the subacromial structures. Subacromial impingement syndrome is one of the most common causes of shoulder pain. The complaint of the majority of patients is pain radiating to the shoulder and arm, especially during overhead movements. Examples of overhead activities in these people include hanging curtains, reaching on a shelf, combing hair, or lifting an object. Subacromial impingement syndrome is a complex disease that occurs not only as a result of compression of the rotator cuff muscles under the acromion, but also due to a combination of external and internal causes. While the diagnosis of the disease can be made with a good history and physical examination, the diagnosis must also be supported by imaging methods.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
60

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Aug 2024

Shorter than P25 for not_applicable

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

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

August 14, 2024

Completed
1 day until next milestone

Study Start

First participant enrolled

August 15, 2024

Completed
4 days until next milestone

First Posted

Study publicly available on registry

August 19, 2024

Completed
1 month until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 25, 2024

Completed
5 days until next milestone

Study Completion

Last participant's last visit for all outcomes

September 30, 2024

Completed
Last Updated

March 5, 2025

Status Verified

August 1, 2024

Enrollment Period

1 month

First QC Date

August 14, 2024

Last Update Submit

February 28, 2025

Conditions

Keywords

Impingement syndromefunctionalitykinesiophobia

Outcome Measures

Primary Outcomes (5)

  • Visuel Analog Scale (VAS)

    Visuel analog scale is a scale where the intensity of pain is marked on a 10 cm horizontal/vertical line. The point "0" indicates no pain, and the point "10" indicates maximum pain. Participants will be asked to mark the point that represents their pain at the beginning and after treatment. The marked point will then be measured with a ruler and recorded in "cm". A higher value indicates more pain. The reliability of the assessment is r=0.79 and the retest validity is r=0.97.

    3 weeks

  • Joint Range of Motion (ROM)

    It refers to the measurement of the amount of movement around a particular joint. This measurement is usually made during a physical therapy evaluation. Physiotherapists measure joint range of motion with the help of a tool called a goniometer. The midpoint of the digital goniometer will be fixed by holding it with the hand, with the pivot point for movement of the shoulder joint placed on the greater tubercle of the humerus bone. A digital goniometer will be used to measure shoulder joint range of motion.

    3 weeks

  • Muscle Strength

    The maximal power that can be generated by a specific muscle or muscle group. Muscular strength is the ability of the muscle to resist resistance. In assessing muscle strength, the force or torque applied during maximal voluntary contraction is measured. Evaluation is performed to detect peripheral muscle weakness before treatment, to plan a personalized resistance exercise training program, and to evaluate post-treatment effectiveness. Many methods including voluntary and involuntary contractions are used to measure muscle strength. The physiotherapist who will perform the application must choose the correct, sensitive and most reliable test appropriate to the clinical conditions.

    3 weeks

  • Disabilities of the Arm, Shoulder and Hand (DASH)

    The questionnaire, which evaluates upper extremity functions and gives an idea about upper extremity functionality, consists of 3 parts: symptoms and daily living activities, sports and musician module. The questionnaire consists of 30 items assessing symptoms and activities of daily living. 21 questions in the survey evaluate difficulty in daily life activities, 5 questions evaluate body symptoms (pain, weakness, stiffness, numbness), and the remaining 4 questions evaluate work skills, sleep status, social function and the patient's self-confidence. A 5-grade system is used in scoring the survey. In the scoring scale from 1 to 5, 1 means "no difficulty" and 5 means "I cannot do it at all". The time to complete the survey is 5-7 minutes and it is a survey that patients can easily answer on their own. The highest score is 100, and high scores indicate low patient functionality.

    3 weeks

  • Tampa Kinesiophobia Scale (TKS)

    The level of kinesiophobia will be assessed with the Tampa Kinesiophobia Scale (TKS). The scale consists of 17 questions. The scoring varies between 17-68, with higher scores indicating higher kinesiophobia.

    3 weeks

Study Arms (3)

Grup A: Traditional Physiotherapy + Sham Kinesiotape

SHAM COMPARATOR

Traditional Physiotherapy: A total of 15 sessions of joint range of motion, stretching exercises and strengthening exercises will be applied 5 days a week for 3 weeks, each session lasting 45 minutes. Friction massage will be applied. In addition, ultrasound, TENS and cold packs will be applied to the patients according to their tolerance. Sham Kinesiotape: 2 days a week, 6 times in total, following conventional physiotherapy for 3 weeks. Kinesio tape 10 cm I strips will be applied on the acromioclavicular joint in the sagittal plane and in the transverse plane from the distal deltoid without applying tension. The tape will be applied twice a week in total, remaining for 3 days and released one day after each application.

Other: Traditional Physiotherapy + Sham Kinesiotape

Grup B: Kinesiotape with Facilitation Method + Traditional Physiotherapy

EXPERIMENTAL

In addition to traditional physiotherapy, traditional physiotherapy will be applied 2 days a week, 6 times in total, followed by 3 weeks. Kinesio tape has been developed to reflect the properties of the skin, its thickness is similar to the epidermis layer of the skin, and its elasticity is similar to the elastic properties of human skin. Participants should be informed that the patch will remain for several days and will not be removed by bathing or swimming. Kinesio tape will be applied to the deltoid muscle with the starting point at 0 tension while the arm is in a relaxed position and will be slightly heated. It will be applied in addition to traditional physiotherapy 2 days a week for 3 weeks.

Other: Kinesiotape with Facilitation Method + Traditional Physiotherapy

Grup C: Kinesiotape with Inhibition Method + Traditional Physiotherapy

EXPERIMENTAL

In addition to traditional physiotherapy, traditional physiotherapy will be applied 2 days a week, 6 times in total, followed by 3 weeks. Kinesio tape will be applied to the deltoid muscle with inhibition and mechanical correction technique, and to the supraspinatus muscle with inhibition technique twice a week, 3 days apart. First of all, it will be applied to the deltoid muscle with the inhibition technique. Y-shaped kinesio tape will be placed 3 cm below the humerus tuberculum deltoidea without stretching. During application, the shoulder will be in maximum extension and external rotation for the front arm of the Y strip, and in 45 degrees transverse flexion and horizontal adduction for the rear arm of the Y strip.

Other: Kinesiotape with Inhibition Method + Traditional Physiotherapy

Interventions

As exercise training, joint range of motion, flexion and abduction external cycle will be practiced with the gymnasts. Circumference measurements will be taken for shoulder bone swelling and for atrophy. Shoulder joint mobilizations will be applied (posterior cutting for flexion limitation, downward shifting and scapular mobilizations for abduction limitation). Flexion and abduction will be stretched externally. Friction massage will be applied. Strengthening exercises for flexion, abduction and external rotation in the lower and upper segments of the shoulder with dumbbells and theraband, shoulder wheel and finger ladder will be practiced. Codman exercises and staff exercises will be practiced.

Grup A: Traditional Physiotherapy + Sham Kinesiotape

Kinesio tape will be applied with 0 tension at the starting point when the arm is in a relaxed position and will be slightly heated. Since the deltoid muscle is a three-headed muscle, it will be applied with 0 tension in the flexed position at the elbow, for the front part, the arm with the elbow in full extension, and for the middle part of the deltoid, the I tape will be applied along the muscle without applying tension.

Grup B: Kinesiotape with Facilitation Method + Traditional Physiotherapy

The Y-shaped kinesio tape will be placed on the deltoid muscle with inhibition and mechanical correction technique, and the Y-shaped kinesio tape will be placed on the supraspinatus muscle with inhibition technique, 3 cm below the humerus tuberculum deltoidea without tension. The Y tape will be applied along the outer edge of the anterior deltoid of the forearm with 15-25% light tension, and the posterior arm will be applied along the outer edge of the posterior deltoid with 15-25% light tension up to the lateral acromion. The last 3-5 cm of the tails will be applied to their permanent locations without tension. The shoulder will be held in maximum transverse extension and external rotation for the forearm of the Y support, and in 45 degrees transverse flexion and horizontal adduction for the posterior arm of the Y support. In addition, ultrasound, electrotherapy and cold application will be applied to the participants depending on their tolerance.

Grup C: Kinesiotape with Inhibition Method + Traditional Physiotherapy

Eligibility Criteria

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

You may qualify if:

  • Diagnosed with subacromial impingement syndrome,
  • Between the ages of 45-65, without a history of shoulder injury other than subacromial impingement and/or shoulder symptoms requiring treatment for the last 1 year,
  • Those who have not had any shoulder surgery before,
  • Patients who agree to participate in the study will be included in the study.

You may not qualify if:

  • Presence of frozen shoulder, previous shoulder surgery,
  • Having received local corticosteroid injection/treatment to the shoulder joint in the last 3 months,
  • Presence of neuromuscular disease, pregnancy,
  • Those with a history of cancer, unstable angina, systemic inflammatory joint disease,
  • Situations where exercise is contraindicated,
  • Patients with orthopedic, rheumatic or congenital disease in the affected upper extremity and communication problems will be excluded from the study.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Yasemin ŞAHBAZ

Istanbul, Istanbul, 34500, Turkey (Türkiye)

Location

Related Publications (5)

  • Poppen NK, Walker PS. Forces at the glenohumeral joint in abduction. Clin Orthop Relat Res. 1978 Sep;(135):165-70.

    PMID: 709928BACKGROUND
  • Neer CS 2nd. Anterior acromioplasty for the chronic impingement syndrome in the shoulder: a preliminary report. J Bone Joint Surg Am. 1972 Jan;54(1):41-50. No abstract available.

    PMID: 5054450BACKGROUND
  • Neer CS 2nd. Impingement lesions. Clin Orthop Relat Res. 1983 Mar;(173):70-7. No abstract available.

    PMID: 6825348BACKGROUND
  • Winter JA, Allen TJ, Proske U. Muscle spindle signals combine with the sense of effort to indicate limb position. J Physiol. 2005 Nov 1;568(Pt 3):1035-46. doi: 10.1113/jphysiol.2005.092619. Epub 2005 Aug 18.

    PMID: 16109730BACKGROUND
  • Visscher CM, Ohrbach R, van Wijk AJ, Wilkosz M, Naeije M. The Tampa Scale for Kinesiophobia for Temporomandibular Disorders (TSK-TMD). Pain. 2010 Sep;150(3):492-500. doi: 10.1016/j.pain.2010.06.002. Epub 2010 Jul 3.

    PMID: 20598804BACKGROUND

MeSH Terms

Conditions

Kinesiophobia

Interventions

Athletic Tape

Condition Hierarchy (Ancestors)

Phobic DisordersAnxiety DisordersMental Disorders

Intervention Hierarchy (Ancestors)

BandagesEquipment and SuppliesOrthotic DevicesOrthopedic EquipmentSurgical Equipment

Study Officials

  • Yasemin ŞAHBAZ, Lecturer

    Beykent University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Model Details: After giving the necessary verbal and written information about the study, patients with informed consent will be randomized and divided into 3 groups of 20 people each. The randomization and treatment of the cases will be done by the same researchers. The evaluation will be carried out before and after the treatment by another researcher who is blind to which group the participants are in. After the initial evaluations are completed, Group 1 will receive 15 sessions of traditional physiotherapy + placebo kinesiotape every day for 3 weeks. In the 2nd group, kinesiotape will be applied with traditional physiotherapy + facilitation method. In the third group, kinesiotape will be applied with traditional physiotherapy + inhibition method.
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

August 14, 2024

First Posted

August 19, 2024

Study Start

August 15, 2024

Primary Completion

September 25, 2024

Study Completion

September 30, 2024

Last Updated

March 5, 2025

Record last verified: 2024-08

Data Sharing

IPD Sharing
Will not share

Locations