Ireland
--:--IST
Recruiting Not applicable

Effects of Corrective External Support and Regional Vibration Applications in Subacromial Pain Syndrome

NCT06409442 · tracked via the Priya Life Science Turkey tracker
Phase
Not applicable
Started
2024-06-24
Last updated
2026-06-26

Condition(s) studied

Subacromial Pain Syndrome

Investigational drug(s) / intervention(s)

Standard Physiotherapy ProgramKinesio TapingLocal Vibration Therapy

Standard Physiotherapy Program: Patients with Subacromial Impingement Syndrome (SIS) will receive a 6-week treatment program. Patients will be given a physiotherapy treatment program by a physiotherapist three times a week, and on the other days, patients will practice six selected simple exercises at home.

Kinesio Taping: In addition to the standard physiotherapy program, kinesio taping (device) will be applied.

Local Vibration Therapy: In addition to the standard physiotherapy program, local vibration (device) will be applied.

Study summary

Sixty three individuals with chronic subacromial pain syndrome will be included in our study. In the evaluations to be made to the participants; Pain intensity will be measured with the Visual Analogue Scale (VAS), joint movement and shoulder proprioception will be measured with the inclinometer, and shoulder muscle strength will be measured with the digital hand dynamometer. In addition, functionality and disability levels will be determined by SPADI and Short form-Questionnaire for Arm, Shoulder and Hand Problems (Q-DASH). Supraspinatus tendon thickness and acromiohumeral space measurements will be made by ultrasonographic imaging. Patient satisfaction will be evaluated with the Visual Analog Patient Satisfaction Scale survey and quality of life will be evaluated with the SF-12 survey (The 12-item Short Form Survey).

Participants will be randomly divided into 3 groups of 21 participants each. In addition to the standard physiotherapy program, taping around the shoulder will be applied to the kinesio taping group, and localized vibration therapy around the shoulder will be applied to the localized vibration therapy group, in addition to the standard physiotherapy program. The Control Group (CG) will receive the same physiotherapy program as the other groups and will attend the same number of sessions as the other groups, accompanied by a physiotherapist. Evaluations will be made and analyzed before treatment, after 3 weeks of treatment, after 6 weeks of treatment, at 12 weeks and at the end of 24 weeks.

Eligibility

Sex
ALL
Min age
18 Years
Max age
—
Healthy volunteers
No
Inclusion Criteria: * Volunteering to participate in the study, * Being over 18 years of age, * Having diagnosed with subacromial impingement syndrome, * SIS-related complaints have persisted for at least 3 months, * Not having received any treatment for shoulder problems in the last 6 months, * No history of shoulder injury other than subacromial impingement and/or shoulder symptoms requiring treatment for the last 1 year, * To be able to read and write Turkish in order to complete all evaluations and applications in the study and to carry out evaluations that require reading and writing. Exclusion Criteria: * Having a history of fractures and surgery in the upper extremity and cervicothoracic region, * Having another neurological, orthopedic or rheumatic shoulder problem such as frozen shoulder or instability, * Having a systemic musculoskeletal disease, * Known chest deformity, scoliosis diagnosis and physical disability, * Presence of a skin problem or a condition that may be a contraindication to the application in the area where KT or LVT will be applied.

Primary outcome measure(s)

  • Shoulder Pain — Baseline, after 3 and 6 weeks of interventions period and then follow up measurement 3. and 6. months
    The level of pain felt during rest and activity will be marked on a 10 cm scale and the result will be recorded by measuring with a ruler. The value '0' means no pain; '10' indicates unbearable pain.
  • Range of Motion (Active and Pain-Free) — Baseline, and after 6 weeks of interventions period
    Active shoulder abduction, flexion, internal and external rotation movements will be measured using a 1-degree interval water-controlled inclinometer (Fabrication End Inc, NewYork, USA) while the patient is in the supine position. Pain-free joint range is the angle at which the patient first feels pain during active movement. Pain-free joint motion will be assessed by measuring pain-free joint motion during active shoulder elevation in the scapular plane with an inclinometer. While the patient is sitting in a chair with back support and lifts his arm up with his thumb pointing up, the angle at which he first feels pain will be recorded one degree below.
  • Muscle Strength — Baseline, and after 6 weeks of interventions period
    Change of trapezius,serratus anterior, supraspinatus and shoulder internal rotation isometric strength (in kg, with hand held dynamometer).The average of three consecutive repetitions will be recorded.
  • Shoulder Pain and Disability Index (SPADI) — Baseline, after 3 and 6 weeks of interventions period and then follow up measurement 3. and 6. months
    Shoulder Pain and Disability Index has 3 subscales: total, pain and disability. The pain subscale consists of 5 questions about shoulder pain during daily living activities, and the disability subscale consists of 8 questions about difficulty in performing daily living activities. A high score indicates increased pain and impaired shoulder function.To answer the questions, patients place a mark on a 10cm visual analogue scale for each question.The means of the two subscales are averaged to produce a total score ranging from 0 (best) to 100 (worst).
  • Short form-Questionnaire for Arm, Shoulder and Hand Problems (Q-DASH) — Baseline, after 3 and 6 weeks of interventions period and then follow up measurement 3. and 6. months
    The level of disability of the patients resulting from the upper extremity was determined by evaluating 11 different daily living activities. Each activity is scored between "1 = no difficulty" and "5 = not able to do it at all". In order for this score to be calculated, at least 10 out of 11 questions must be answered. Depending on the answers to the questions, a result score ranging from 0 (no disability)(best) to 100 (very serious disability)(worst) is calculated.
  • Quality of Life Assessment — Baseline, after 3 and 6 weeks of interventions period and then follow up measurement 3. and 6. months
    Short form 12-SF-12 survey will be used to evaluate quality of life. It assesses physical and mental health, the two main components of overall health. SF-12 consists of twelve questions. Mental and physical component scores will be calculated in accordance with the algorithm described by Ware.Scores can range from 16 to 112. A higher score indicates higher quality of life.

Trial sites (1)

FacilityCityRegionStatus
Dokuz Eylül University Izmir Balçova Recruiting
Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

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