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

NCT ID: NCT06409442

Last Updated: 2025-02-07

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: NA
• Total Enrollment: 63 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2024-06-24
• Study Completion Date: 2027-05-30

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.

Detailed Description

The purpose of this study is to compare the effects of 6 week physiotherapy and kinesio taping (KT) combination (PKT) or physiotherapy and local vibration therapy (LVT) combination (PLVT) with physiotherapy program without these methods and with each other, after 3 weeks and 6 weeks of treatment, and to determine the differences in maintenance of their effects after 3 and 6 months. Shoulder pain is a common complaint that affects about one-third of individuals at some point in their lives. Subacromial Impingement Syndrome (SIS) is a non-infectious and often chronic disease that is the most common cause of shoulder pain. The incidence of the disease with age, its severity and the stage progress. Pain, loss of range of motion (ROM) and strength, functional limitations, and proprioceptive deficits are the findings of the disease. The changes in supraspinatus tendon thickness (SSTT) and narrowing in the subacromial space (SAS) are important parameters associated with these findings. SIS has a significant impact on the health-related quality of life (QoL) of patients, and the financial burden of the disease is high. Achieving and maintaining the treatment success for SIS is a challenging process due to the multi-factor pathogenesis and complexity of the joint. Exercise therapy is essential in treatment; however, some adjunct interventions could potentially improve treatment success. KT and LVT, which aim to optimize the muscle function and show similarities in terms of their facilitation and inhibition effects, have recently come to the fore in this context. Shoulder KT is used for reducing pain, improving function, proprioception, and SAS. However, there is moderate evidence that KT does not have beneficial effects over the sham-tape; studies have a high risk of bias, and acute or short-term results have been investigated with isolated applications. LVT is also used to improve muscle strength, ROM, and motor control. Portable and easy to use massage devices for LVT are on the agenda recently. However, in a single case report in the shoulder reported reduced pain, sensitivity, shoulder ROM, and increased muscle strength, but the results could not be generalized. It may be possible for LVT to improve pain, function, proprioception, and SAS, similar to KT. The positive effects of either method can positively affect the patients' satisfaction and QoL. Still, patient satisfaction has not been investigated before, and there is one investigation for the effects of KT on QoL. It is recommended to determine whether the addition of these methods to physiotherapy programs is more effective than the physiotherapy interventions without these methods with high-quality randomized controlled studies that have a high level of evidence (sufficient number of participants, sufficiently powered results, longer follow-up). Sixty three SIS patients will be included in this study. Short, medium, and long-term effects of 6 weeks PKT or PLVT will be compared objectively with each other and with a rehabilitation program without these methods. Shoulder pain will be evaluated with visual analog scale, ROM and proprioception with an inclinometer, muscle strength with the digital hand dynamometer, SSTT and SAS with ultrasonography, in addition, functionality and disability levels will be determined by SPADI and Short form-Questionnaire for Arm, Shoulder and Hand Problems (Q-DASH). And 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 maintenance of the effects will be compared between the methods in long-term. Our study will be the first randomized controlled study having these characteristics. The investigators believe that it will contribute significantly to the literature, will help to choose the best management for SIS, the problematic treatment process will succeed in a shorter time and positive results last longer, useful information will be provided to the researchers and healthcare professionals for implementing rational treatment, therefore the success of SIS treatment can be increased, and it can contribute to the reduction of financial burdens.

Conditions

Subacromial Pain Syndrome

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: CROSSOVER
• Primary Study Purpose: TREATMENT
• Blinding Strategy: DOUBLE

Study Groups

Control Group (CG) (Standard Physiotherapy Program)

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

Group Type: ACTIVE_COMPARATOR

Standard Physiotherapy Program

Intervention Type: 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.

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

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

Group Type: ACTIVE_COMPARATOR

Standard Physiotherapy Program

Intervention Type: 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.

Kinesio Taping

Intervention Type: OTHER

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

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

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.

Group Type: EXPERIMENTAL

Standard Physiotherapy Program

Intervention Type: 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.

Local Vibration Therapy

Intervention Type: OTHER

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

Interventions

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.

Intervention Type: OTHER

Kinesio Taping

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

Intervention Type: OTHER

Local Vibration Therapy

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

Intervention Type: OTHER

Eligibility Criteria

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.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Dokuz Eylul University

OTHER

Sponsor Role: lead

Responsible Party

Sevgi Sevi Yeşilyaprak

PhD, PT, Assoc. Prof.

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Sevgi Sevi Yeşilyaprak, PhD

Role: STUDY_DIRECTOR

Dokuz Eylul University

Ezgi İrem Küçük, MSc Student

Role: STUDY_CHAIR

Dokuz Eylul University

Zana Gündüz, Bachelor's

Role: STUDY_CHAIR

Dokuz Eylul University

Mehmet Erduran, M.D

Role: STUDY_CHAIR

Dokuz Eylul University

Damla Karabay, PhD

Role: STUDY_CHAIR

İzmir Katip Çelebi University

Nursen İlçin, PhD

Role: STUDY_CHAIR

Dokuz Eylul University

Halime Ezgi Türksan, PhD Student

Role: STUDY_CHAIR

Dokuz Eylul University

Fatma Özden, PhD Student

Role: STUDY_CHAIR

Dokuz Eylul University

Locations

Dokuz Eylül University

Izmir, Balçova, Turkey (Türkiye)

Site Status: RECRUITING

Countries

Turkey (Türkiye)

Central Contacts

Sevgi Sevi Yeşilyaprak, PhD

Role: CONTACT

ssyesilyaprak@gmail.com

+905055882829

Fatma Özden, PhD Student

Role: CONTACT

fatik-93@hotmail.com

+905544473147

Facility Contacts

Sevgi Sevi Yeşilyaprak, PhD

Role: primary

ssyesilyaprak@gmail.com

+905055882829

Other Identifiers

6920-GOA

Identifier Type: -

Identifier Source: org_study_id