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

Subacromial Pain Syndrome Clinical Trial

Official title:

Effects of Corrective External Support and Regional Vibration Applications Added to the Rehabilitation Program in Subacromial Pain Syndrome: Randomized Controlled Study

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT06409442
• Other study ID #: 6920-GOA
• Status: Not yet recruiting
• Phase: N/A
• Start date: May 15, 2024
• Est. completion date: May 30, 2027

Study information

• Verified date: May 2024
• Source: Dokuz Eylul University
• Contact: Sevgi Sevi Yesilyaprak, PhD
• Phone: +902324124926
• Email: sevgisubasi[@]deu.edu.tr
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 63
• Est. completion date: May 30, 2027
• Est. primary completion date: November 20, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Somatoform Disorders
• Subacromial Pain Syndrome
• Syndrome

Intervention

Other:
• 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.

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Dokuz Eylul University

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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	Patient Satisfaction Rating	The patient's symptom status (degree of improvement), physiotherapist (care provided) and overall satisfaction with the treatment will be evaluated by giving a score out of 10 with the Visual Analog Patient Satisfaction Scale. The lowest level individual is not satisfied at all; The highest level indicates that they are completely satisfied. In follow-up evaluations, only symptoms (degree of improvement) will be questioned.	Baseline, after 3 and 6 weeks of interventions period and then follow up measurement 3. and 6. months
Secondary	Assessment of the Patient's Perceived Change in Condition	The patient's perceived change in condition will be measured using the Global Change Rating Scale. This rating scale measures the person's perception of the change in their condition after treatment. The patient evaluates the overall change from the day he started treatment to the day he finished treatment using a 7-point Likert Scale. On the scale, a score of -7 would be scored as much, much worse, a score of 0 would be scored as almost the same, and a score of +7 would be scored as much, much better.	Baseline, after 3 and 6 weeks of interventions period and then follow up measurement 3. and 6. months
Secondary	Ultrasonographic Measurements	Ultrasonographic measurements will be performed by examining images obtained in 2D using the LOGIQ e ultrasonography unit (LOGIQ e Ultrasound, GE(General Electric Company ) Healthcare, USA). A 7-12 megahertz(MHz) linear transducer will be used in the evaluations.; To measure supraspinatus tendon thickness, the transducer will be placed perpendicular to the supraspinatus tendon in the anterior of the shoulder and two measurements will be made and the average will be taken. For acromiohumeral distance measurement, images of the humerus and acromion will be taken together at 0? and 60? scapular plane shoulder elevation, with the location of the transducer as the standard, 2.1 cm behind the first acromial arch in the coronal plane. It gives the shortest distance determined by 2D linear measurement between the acromion and humerus on the recorded images. The average of the measurements taken from the 1st and 2nd measurement locations will be recorded.	Baseline, and after 6 weeks of interventions period
Secondary	Proprioception	Change of shoulder abduction joint position sense (with digital inclinometer in degree) (Target angel:100 degree abduction). The target angle to be tested will be taught by the investigators with eyes open 3 times and eyes closed 3 times. The participant will then be asked to bring it to the target angle with their eyes closed. The deviation value from the target angle will be recorded.	Baseline, and after 6 weeks of interventions period