Clinical trial NCT06409442: Effects of Corrective External Support and Regional Vibration Applications in Subacromial Pain Syndrome
Official title: Effects of Corrective External Support and Regional Vibration Applications Added to the Rehabilitation Program in Subacromial Pain Syndrome: Randomized Controlled Study
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Subacromial Pain Syndrome
Keywords: shoulder impingement syndrome
pain
physical therapy and rehabilitation
ultrasonography
Lead sponsor: Dokuz Eylul University
Sponsor class: OTHER
First posted: 2024-05-10
Enrollment: 63
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Intervention model description: Kinesio taping group (KTG), Local vibration therapy group (LVTG), and Control group (CG)
Primary purpose: TREATMENT

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.

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.

Primary outcomes:
measure: Shoulder Pain
timeFrame: Baseline, after 3 and 6 weeks of interventions period and then follow up measurement 3. and 6. months
measure: Range of Motion (Active and Pain-Free)
timeFrame: Baseline, and after 6 weeks of interventions period
measure: Muscle Strength
timeFrame: Baseline, and after 6 weeks of interventions period
measure: Shoulder Pain and Disability Index (SPADI)
timeFrame: Baseline, after 3 and 6 weeks of interventions period and then follow up measurement 3. and 6. months
measure: Short form-Questionnaire for Arm, Shoulder and Hand Problems (Q-DASH)
timeFrame: Baseline, after 3 and 6 weeks of interventions period and then follow up measurement 3. and 6. months
measure: Quality of Life Assessment
timeFrame: Baseline, after 3 and 6 weeks of interventions period and then follow up measurement 3. and 6. months
Secondary outcomes:
measure: Patient Satisfaction Rating
timeFrame: Baseline, after 3 and 6 weeks of interventions period and then follow up measurement 3. and 6. months
measure: Assessment of the Patient's Perceived Change in Condition
timeFrame: Baseline, after 3 and 6 weeks of interventions period and then follow up measurement 3. and 6. months
measure: Ultrasonographic Measurements
timeFrame: Baseline, and after 6 weeks of interventions period
measure: Proprioception
timeFrame: Baseline, and after 6 weeks of interventions period
Other outcomes:
Locations:
city: İzmir
country: Turkey
facility: Dokuz Eylül University
state: Balçova
Study officials:
affiliation: Dokuz Eylul University
name: Sevgi Sevi Yeşilyaprak, PhD
role: STUDY_DIRECTOR
affiliation: Dokuz Eylul University
name: Ezgi İrem Küçük, MSc Student
role: STUDY_CHAIR
affiliation: Dokuz Eylul University
name: Zana Gündüz, Bachelor's
role: STUDY_CHAIR
affiliation: Dokuz Eylul University
name: Mehmet Erduran, M.D
role: STUDY_CHAIR
affiliation: İzmir Katip Çelebi University
name: Damla Karabay, PhD
role: STUDY_CHAIR
affiliation: Dokuz Eylul University
name: Nursen İlçin, PhD
role: STUDY_CHAIR
affiliation: Dokuz Eylul University
name: Halime Ezgi Türksan, PhD Student
role: STUDY_CHAIR
affiliation: Dokuz Eylul University
name: Fatma Özden, PhD Student
role: STUDY_CHAIR
References: