Ignite Creation Date:
2024-05-11 @ 8:31 AM
Last Modification Date:
2024-10-26 @ 3:29 PM
Study NCT ID:
NCT06409442
Status:
RECRUITING
Last Update Posted:
2024-06-25
First Post:
2024-05-07
Brief Title:
Effects of Corrective External Support and Regional Vibration Applications in Subacromial Pain Syndrome
Sponsor:
Dokuz Eylul University
Organization:
Dokuz Eylul University
Study Overview
Official Title:
Effects of Corrective External Support and Regional Vibration Applications Added to the Rehabilitation Program in Subacromial Pain Syndrome Randomized Controlled Study
Status:
RECRUITING
Status Verified Date:
2024-06
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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
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
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None