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

NCT06409442 | Recruiting DMC

• 1 other identifier: 6920-GOA
• Study Type: interventional
• Target: 63
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Subacromial Pain Syndrome

Keywords

shoulder impingement syndrome; pain; physical therapy and rehabilitation; ultrasonography

Outcome Measures

Primary Outcomes (6)

• Shoulder Pain

  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.

  Baseline, after 3 and 6 weeks of interventions period and then follow up measurement 3. and 6. months

• Range of Motion (Active and Pain-Free)

  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.

  Baseline, and after 6 weeks of interventions period

• Muscle Strength

  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.

  Baseline, and after 6 weeks of interventions period

• Shoulder Pain and Disability Index (SPADI)

  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).

  Baseline, after 3 and 6 weeks of interventions period and then follow up measurement 3. and 6. months

• Short form-Questionnaire for Arm, Shoulder and Hand Problems (Q-DASH)

  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.

  Baseline, after 3 and 6 weeks of interventions period and then follow up measurement 3. and 6. months

• Quality of Life Assessment

  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.

  Baseline, after 3 and 6 weeks of interventions period and then follow up measurement 3. and 6. months

Secondary Outcomes (4)

• Patient Satisfaction Rating

  Baseline, after 3 and 6 weeks of interventions period and then follow up measurement 3. and 6. months

• Assessment of the Patient's Perceived Change in Condition

  Baseline, after 3 and 6 weeks of interventions period and then follow up measurement 3. and 6. months

• Ultrasonographic Measurements

  Baseline, and after 6 weeks of interventions period

• Proprioception

  Baseline, and after 6 weeks of interventions period

Study Arms (3)

Control Group (CG) (Standard Physiotherapy Program)

ACTIVE COMPARATOR

Patients with subacromial pain syndrome will receive a 6-week treatment program. Patients will be given a treatment program by a physiotherapist three times a week, and on the other days, patients will practice six selected simple exercises at home. Standard Physiotherapy Program: The physiotherapy program will be given to all groups in the same way; It consists of patient education, Transcutaneous Electrical Nerve Stimulation (TENS) (20 minutes in each session), cold or hot pack application (15 minutes), mobilization and exercise program. Mobilization application is as follows: * Glenohumeral joint posterior glide * Glenohumeral joint inferior glide * Acromioclavicular joint inferior glide * Scapular mobilization The exercise program is as follows: * Phase 1 exercises * Phase 2 exercises * Phase 3 exercises

Other: Standard Physiotherapy Program

Kinesio Taping Group (KTG) (Standard Physiotherapy Program + Kinesio Taping)

ACTIVE COMPARATOR

In the group where kinesio taping will be added to Standard Physiotherapy Program, tape (Kinesio Tex, Standard 5 cm, KT-X-050, Tokyo, Japan) application will be performed by a certified physiotherapist. It will be used for 3 days, and the application will be repeated by the physiotherapist, the next day. Before taping, an allergic reaction test to the tape will be performed, if no allergy will be observed, participants will be taped and the tape maintenance brochure will be giving. Muscles for inhibition techniques: * Supraspinatus Muscle * Deltoid Muscle * Upper Trapezium Muscle Muscles for facilitation techniques: * Serratus Anterior Muscle * Lower Trapezium Muscle

Other: Standard Physiotherapy Program; Other: Kinesio Taping

Local Vibration Therapy Group (LVTG) (Standard Physiotherapy Program + Local Vibration Therapy)

EXPERIMENTAL

In the LVT group, LVT via the Hypervolt™ (HYPERICE Inc, US) vibrating massage device will be added to Standard Physiotherapy Program. This device gives vibration with five different speed settings, vibrating at 3,200 percussions per minute. There are five different head options. The ball head attachment was chosen as it is the least aggressive option and the vibration from the device will be applied to the relevant muscle body. For the facilitator effect, high frequency application will be made to the lower trapezius and serratus anterior muscles. For the inhibitory effect, the upper trapezius, deltoid, pectoralis minor, and supraspinatus muscles will be applied at low frequency. The application will be 5 minutes for each muscle, for a total of 30 minutes. During the application, the speed will be controlled with a metronome, the travel time along the body of the relevant muscle will be 10 seconds, and the return time to the starting point will be 10 seconds.

Other: Standard Physiotherapy Program; Other: Local Vibration Therapy

Interventions

Standard Physiotherapy Program OTHER

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.

Control Group (CG) (Standard Physiotherapy Program); Kinesio Taping Group (KTG) (Standard Physiotherapy Program + Kinesio Taping); Local Vibration Therapy Group (LVTG) (Standard Physiotherapy Program + Local Vibration Therapy)

Kinesio Taping OTHER

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

Kinesio Taping Group (KTG) (Standard Physiotherapy Program + Kinesio Taping)

Local Vibration Therapy OTHER

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

Local Vibration Therapy Group (LVTG) (Standard Physiotherapy Program + Local Vibration Therapy)

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Dokuz Eylul University: lead

Study Sites (1)

Dokuz Eylül University

Izmir, Balçova, 35330, Turkey (Türkiye)

RECRUITING

MeSH Terms

Conditions

Shoulder Impingement Syndrome; Pain

Condition Hierarchy (Ancestors)

Joint Diseases; Musculoskeletal Diseases; Shoulder Injuries; Wounds and Injuries; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Sevgi Sevi Yeşilyaprak, PhD

  Dokuz Eylul University

  STUDY DIRECTOR

• Ezgi İrem Küçük, MSc Student

  Dokuz Eylul University

  STUDY CHAIR

• Zana Gündüz, Bachelor's

  Dokuz Eylul University

  STUDY CHAIR

• Mehmet Erduran, M.D

  Dokuz Eylul University

  STUDY CHAIR

• Damla Karabay, PhD

  İzmir Katip Çelebi University

  STUDY CHAIR

• Nursen İlçin, PhD

  Dokuz Eylul University

  STUDY CHAIR

• Halime Ezgi Türksan, PhD Student

  Dokuz Eylul University

  STUDY CHAIR

• Fatma Özden, PhD Student

  Dokuz Eylul University

  STUDY CHAIR

Central Study Contacts

Sevgi Sevi Yeşilyaprak, PhD

CONTACT

+905055882829; ssyesilyaprak@gmail.com

Fatma Özden, PhD Student

CONTACT

+905544473147; fatik-93@hotmail.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: PhD, PT, Assoc. Prof.

Model Details: Kinesio taping group (KTG), Local vibration therapy group (LVTG), and Control group (CG)

Study Record Dates

• First Submitted: May 7, 2024
• First Posted: May 10, 2024
• Study Start: June 24, 2024
• Primary Completion: December 20, 2025
• Study Completion (Estimated): May 30, 2027
• Last Updated: February 7, 2025

Record last verified: 2025-02

Locations

TU (1)