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Does MI Have a Therapeutic Role in Arthroscopic Rotator Cuff Repair?

Primary Purpose

Rotator Cuff Tears, Motor Imagery, Muscle Activity

Status
Not yet recruiting
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Motor Imagery
Physical Therapy
Sponsored by
Alanya Alaaddin Keykubat University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional supportive care trial for Rotator Cuff Tears focused on measuring Motor Imagery, Muscle Activity, Muscular Atrophy, Rotator Cuff Tears

Eligibility Criteria

20 Years - 65 Years (Adult, Older Adult)All SexesAccepts Healthy Volunteers

Inclusion Criteria: Ability to speak and understand Turkish - Previous arthroscopic rotator cuff repair Achieving a minimum of 40 points on the Kinesthetic and Visual Imagery Questionnaire -20 (KGIA-20) Access to adequate technological devices for communication and follow-up Exclusion Criteria: Who with neurological diseases that may cause functional impairment. Patients who have another shoulder problem and/or have had previous shoulder surgery on the same upper extremity. Who wanted to leave the study at their own request Who could not continue to work due to any additional discomfort developed

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    Experimental

    Experimental

    Arm Label

    The Motor Imagery (MI) Group

    Physical Therapy (PT) Group

    Arm Description

    MI training will be prepared using the Microsoft PowerPoint program which includes written, visual and audio materials, as well as features that can be sent to participants ' phones/tablets/computers. The MI training will allow the participant to perform visual and kinesthetic imagery with visual and audible notifications and will include 6 exercises for the muscles around the shoulder, 3 exercises for strengthening, and dynamic stabilization for the muscles around the scapula. In each presentation, verbal cues will be given to explain how to imagine the movement while a visual of the motor movement is displayed on the screen. During MI exercises, participants will be called once a week and their MI practices will be followed up. After the first four weeks of MI training, the MI group will also participate in a four-week physical therapy program.

    Following the preoperative evaluations, both groups will be shown remedial exercises (pumping exercises that activate the circulation), flexion, and extension wrist exercises, which they should do for four weeks. After a 4-week immobilization period, participants in the PT Group will begin a physical therapy program that includes routine electrotherapy (TENS), cold pack therapy, joint range of motion exercises, and strengthening exercises for the muscles around the shoulder.

    Outcomes

    Primary Outcome Measures

    Change of Muscle activity
    Change of Muscle activity will be evaluated with superficial Electromyography (EMG) (BTS Bioengineering Free EMG 100 RT).
    Change of shoulder functional level
    Disabilities of the Arm, Shoulder, and Hand Questionnaire (DASH) will be used to determine the upper extremity functional level.The total of all item scores was then used to calculate the interrogation score, which ranged from 0 (no disability) to 100. (most severe disability). The first 20 questions concern physical competence, while the last ten concern pain and functional and environmental limitations.
    Change of Kinesthetic and visual imagery levels
    The Kinesthetic and Visual Imagery Questionnaire- KVIQ-20 will be used to assess the kinesthetic and visual imagery levels of healthy and physically disabled individuals.The questionnaire contains a total of 20 titles, 10 of which are visual and 10 of which are kinesthetic. The intensity level of imagery is recorded on a 5-point Likert scale with the questionnaire (5 = appearance of a live image; 1 = no image or sensation).
    Change of Kinesiophobia
    Kinesiophobia was evaluated with Tampa Scale of Kinesiophobia (TSK).TSK is a 17-question checklist. The scale employs a 4-point Likert scoring system (1= strongly disagree, 4= completely agree).
    Change of Patient Satisfaction
    A Numerical Evaluation Scale will be used to evaluate a 2-question satisfaction questionnaire. This scale is made up of a horizontal straight line 10 cm long. The line has a value of 0 at the start and a value of 10 at the end, from left to right. On a scale of 0 to 10, patients will be asked to rate their level of satisfaction.

    Secondary Outcome Measures

    Descriptive Information
    Age, gender, dominant hand, previous diseases, occupation and contact information of the patients were recorded in the descriptive information form.
    Change in Pain-Visual analog scale
    Pain of patients during sleep, rest and activity will evaluate using a visual analog scale (VAS).This scale is made up of a 10 cm horizontal straight line. When viewed from left to right, a 0 at the start of the line indicates no pain, and a 10 at the end indicates severe pain.
    Change of Range of Motion
    The limitation of shoulder joint flexion, extension, abduction, adduction, internal and external rotation movements will be measured using a universal goniometer and recorded in degrees(˚).
    Change in muscle atrophy
    For changes in muscle atrophy, circumference measurements (one of Anthropometric measurements) will be used.

    Full Information

    First Posted
    December 8, 2022
    Last Updated
    December 20, 2022
    Sponsor
    Alanya Alaaddin Keykubat University
    Collaborators
    Pamukkale University, Alanya Allaaddin Keykubat University Hospital, Alanya Hamdullah Emin Pasha University
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    1. Study Identification

    Unique Protocol Identification Number
    NCT05670080
    Brief Title
    Does MI Have a Therapeutic Role in Arthroscopic Rotator Cuff Repair?
    Official Title
    Does Motor Imagination Have a Therapeutic Role in Arthroscopic Rotator Cuff Repair? Randomized Controlled, Single-Blind Trial
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    December 2022
    Overall Recruitment Status
    Not yet recruiting
    Study Start Date
    January 1, 2023 (Anticipated)
    Primary Completion Date
    July 15, 2023 (Anticipated)
    Study Completion Date
    July 15, 2024 (Anticipated)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Principal Investigator
    Name of the Sponsor
    Alanya Alaaddin Keykubat University
    Collaborators
    Pamukkale University, Alanya Allaaddin Keykubat University Hospital, Alanya Hamdullah Emin Pasha University

    4. Oversight

    Studies a U.S. FDA-regulated Drug Product
    No
    Studies a U.S. FDA-regulated Device Product
    No
    Data Monitoring Committee
    Yes

    5. Study Description

    Brief Summary
    Objective: The aim of this study is to investigate the effect of motor imagery on muscle activity, pain, and function in arthroscopic rotator cuff repair. Methods: As a result of the power analysis (G-Power), 36 participants are planned to be included in this study Block randomization will be used to divide participants into 2 groups, each with at least 18 participants: Group 1 (MI group) and Group 2 (Control group) (Randomizer.org). Both groups will receive a 4-week physical therapy program. MI (Motor Imagination) group will receive a motor imagination program in addition to the physical therapy program. Data will collect using the visual analog scale (VAS), goniometric measurement, circumference measurement, Disabilities of the Arm, Shoulder, and Hand Questionnaire (DASH), Kinesthetic and Visual Imagery Questionnaire- KVIQ-20, Tampa Kinesiophobia Scale, 3-question satisfaction questionnaire, superficial Electromyography (EMG) (BTS Bioengineering Free EMG 100 RT). Practice Implications: The current study will contribute to understanding how motor imagination affects muscle activity and muscle atrophy.
    Detailed Description
    After shoulder trauma, the rotator cuff may sustain tears of varying degrees. Degenerative rotator cuff tears are an important cause of shoulder pain and dysfunction. Rotator cuff injuries can be treated conservatively, medically, and surgically. Surgical treatment can be performed as arthroscopic-assisted mini-open or full arthroscopic techniques. After rotator cuff repair, long-term immobilization can lead to complications of scar formation and related shoulder stiffness, pain, muscle/tendon atrophy, and delayed return to functional and occupational activities. Motor imagery (MI) can be used in cases that cause immobilization such as pain, fatigue, and loss of strength during and after injury, or in cases of limited access to healthcare facilities. Motor imagery is the imagining of action without its physical execution and motor imagery elicits activity in brain regions that are normally activated during actual task performance. The brain perceives real experiences and the visualization process as similar. For this reason, imagery is considered a mental exercise. The functional equivalence hypothesis shows that there is a great deal of overlap between the neural substrates of physical and imagined movement execution. In a study examining brain signals during magnetoencephalographic (MEG) evaluation and motor movements, it was stated that the primary motor (less than motor activity) and posterior parietal cortex were activated during MI. Today, the majority of mental exercise studies are carried out in the field of neurological rehabilitation. There are many studies on stroke, multiple sclerosis, Parkinson's, spinal cord injury, and phantom pain. MI is an effective method for motor learning that is also used in orthopedics and sports. The MI application may be an appropriate tool for professional athletes to maintain and improve their physical performance capacity. In a systematic review of the effect of MI on pain and motor function after spinal cord injury, the majority of the findings confirmed the benefits of MI interventions on the motor function when used concurrently with physical exercises. According to the findings of the systematic review published by Colmenero et al., MI has positive effects on phantom pain. Studies in patients with chronic shoulder pain syndrome and subacromial impingement syndrome have reported positive effects of MI on pain and shoulder function and active range of motion. Significantly positive results were observed in pain and disability scores after the 4th week with MI application in rotator cuff patients. Significantly positive results were observed in pain and disability scores after the 4th week of MI application in rotator cuff patients. In conclusion, extensive experimental research indicates that MI is a valuable and cost-effective technique for improving engine performance and recovery. There has been no research into the effectiveness of MI after rotator cuff repair. The aim of this study is to investigate the effect of motor imagery on muscle activity, pain, and function in arthroscopic rotator cuff repair. Methods: Participants: Volunteer participants who applied to the Orthopedics and Traumatology unit at Alanya Alaaddin Keykubat University Hospital, underwent arthroscopic rotator cuff repair by the same surgeon, and met the inclusion and exclusion criteria will take part in the study. Each participant enrolled in the study will be given detailed information about the study, and their written and verbal consent will be obtained. According to the power analysis made with the G-power program, it was found that 80% power can be obtained with 95% confidence when at least 30 people are included in the study. While calculating the sample size, the results of the superficial EMG (-superior trapezius muscle peak dynamic value [experimental group: 35.99 (standard deviation: 14.39), control group 19.57 (standard deviation: 15.97)] were taken as a basis, and the effect size was calculated as = 1.08. The risk of case loss was taken into account by taking a reserve rate of 20%, and it was planned to include 36 participants. The cases will be divided into 2 groups by block randomization using the internet program, consisting of at least 18 individuals: Group 1 [MI group] and Group 2 [Control group] (Randomizer.org). Study Protocol: The study will be divided into two parallel groups: the MI group and the Control group. Both groups will participate in a routine physical therapy program after 4 weeks of immobilization, with the MI group receiving additional motor imagery training during the preoperative period. A physiotherapist with a master's degree who will apply for the treatment program and is unaware of the study's content will administer the assessments in the pre-operative period and post-operative 8th week. Data will collect using the descriptive Information form (prepared by the principal investigator), visual analog scale (VAS), goniometric measurement, circumference measurement, Disabilities of the Arm, Shoulder, and Hand Questionnaire (DASH), Kinesthetic and Visual Imagery Questionnaire- KVIQ-20, Tampa Kinesiophobia Scale, 3-question satisfaction questionnaire, superficial Electromyography (EMG) (BTS Bioengineering Free EMG 100 RT). Training and Exercise Applications: MI training will be provided to Group 1 participants who are planning for rotator cuff repair in the pre-surgical period. The training will be prepared using the Microsoft PowerPoint program which includes written, visual and audio materials, as well as features that can be sent to participants ' phones/tablets/computers. MI training will allow the participant to perform visual and kinesthetic imagery with visual and audible notifications and will include 6 exercises for the muscles around the shoulder, 3 exercises for strengthening, and dynamic stabilization for the muscles around the scapula. In each presentation, verbal cues will be given to explain how to imagine the movement while a visual of the motor movement is displayed on the screen. Participants will be given 10 seconds of time, beginning and ending with an audible beep, and each exercise will be repeated 10 times before transitioning to the next exercise. Participants will be told in detail that they should begin MI exercises on the third day after surgery and continue them for four weeks. During MI exercises, participants will be called once a week and their MI practices will be followed up, as well as support for the questions and problems they experience. Group 1 will then participate in a 4-week physical therapy program, which will include electrotherapy, cold application, joint range of motion exercises, and strengthening exercises for the muscles around the shoulder. Following the preoperative evaluations, both groups will be shown remedial exercises (pumping exercises that activate the circulation), flexion, and extension wrist exercises, which they should do for four weeks. After a 4-week immobilization period, participants in Group 2 will begin a physical therapy program that includes routine electrotherapy (TENS), cold pack therapy, joint range of motion exercises, and strengthening exercises for the muscles around the shoulder. The MI training will be applied by the principal investigator. The physical therapy program will be applied by a physiotherapist with a master's degree and 8 years of professional experience in the field of orthopedic rehabilitation, who is different from the principal investigator of the study. Statistical Analysis: In the statistical analysis of data will obtain in this study, a Windows-based SPSS (IBM SPSS Statistics, Version 24.0, Armonk, NY, USA) package program will use. Continuous variables will express as a mean ± standard deviation or as a median (minimum-maximum values), and categorical variables as a number and percent. Analytical (Kolmogorov-Smirnov/Shapiro-Wilks test) and visual (Histogram and probability graphs) methods will use to test the conformity of data for normal distribution. When the parametric test assumptions were provided, Independent Sample T-Test will use to compare independent group differences; when the parametric test assumptions were not provided, the Mann Whitney-U test will use to compare independent group differences. In the dependent group analyses; when the parametric test assumptions were provided, Paired Sample T-Test will use; when the parametric test assumptions were not provided, Wilcoxon Test will use. Chi-Square Analysis and Fisher Exact Test will use compare differences between categorical variables.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Rotator Cuff Tears, Motor Imagery, Muscle Activity, Atrophy, Muscular, Patient Satisfaction, Kinesiophobia, Shoulder Pain
    Keywords
    Motor Imagery, Muscle Activity, Muscular Atrophy, Rotator Cuff Tears

    7. Study Design

    Primary Purpose
    Supportive Care
    Study Phase
    Not Applicable
    Interventional Study Model
    Parallel Assignment
    Model Description
    The study will be divided into two parallel groups: the MI group and the Control group. Both groups will participate in a routine physical therapy program after 4 weeks of immobilization, with the MI group receiving additional motor imagery training during the preoperative period. MI training will be provided to Group 1 participants who are planning for rotator cuff repair in the pre-surgical period by the corresponding researcher. The physical therapy program will be applied by a physiotherapist with a master's degree and 8 years of professional experience in the field of orthopedic rehabilitation, who is different from the corresponding researcher of the study.
    Masking
    ParticipantCare Provider
    Masking Description
    A physiotherapist with a master's degree who is unaware of the study's content will apply the physical therapy program and assessments. Participants will take physical therapy program and MI training without being told which group they were in.
    Allocation
    Randomized
    Enrollment
    36 (Anticipated)

    8. Arms, Groups, and Interventions

    Arm Title
    The Motor Imagery (MI) Group
    Arm Type
    Experimental
    Arm Description
    MI training will be prepared using the Microsoft PowerPoint program which includes written, visual and audio materials, as well as features that can be sent to participants ' phones/tablets/computers. The MI training will allow the participant to perform visual and kinesthetic imagery with visual and audible notifications and will include 6 exercises for the muscles around the shoulder, 3 exercises for strengthening, and dynamic stabilization for the muscles around the scapula. In each presentation, verbal cues will be given to explain how to imagine the movement while a visual of the motor movement is displayed on the screen. During MI exercises, participants will be called once a week and their MI practices will be followed up. After the first four weeks of MI training, the MI group will also participate in a four-week physical therapy program.
    Arm Title
    Physical Therapy (PT) Group
    Arm Type
    Experimental
    Arm Description
    Following the preoperative evaluations, both groups will be shown remedial exercises (pumping exercises that activate the circulation), flexion, and extension wrist exercises, which they should do for four weeks. After a 4-week immobilization period, participants in the PT Group will begin a physical therapy program that includes routine electrotherapy (TENS), cold pack therapy, joint range of motion exercises, and strengthening exercises for the muscles around the shoulder.
    Intervention Type
    Behavioral
    Intervention Name(s)
    Motor Imagery
    Intervention Description
    Motor imagery is the imagining of action without its physical execution and motor imagery elicits activity in brain regions that are normally activated during actual task performance. The brain perceives real experiences and the visualization process as similar. For this reason, imagery is considered a mental exercise
    Intervention Type
    Behavioral
    Intervention Name(s)
    Physical Therapy
    Intervention Description
    Electrotherapy (TENS), cold pack therapy, joint range of motion exercises, and strengthening exercises for the muscles around the shoulder.
    Primary Outcome Measure Information:
    Title
    Change of Muscle activity
    Description
    Change of Muscle activity will be evaluated with superficial Electromyography (EMG) (BTS Bioengineering Free EMG 100 RT).
    Time Frame
    1 week before surgery and week 8 after surgery
    Title
    Change of shoulder functional level
    Description
    Disabilities of the Arm, Shoulder, and Hand Questionnaire (DASH) will be used to determine the upper extremity functional level.The total of all item scores was then used to calculate the interrogation score, which ranged from 0 (no disability) to 100. (most severe disability). The first 20 questions concern physical competence, while the last ten concern pain and functional and environmental limitations.
    Time Frame
    1 week before surgery and week 8 after surgery
    Title
    Change of Kinesthetic and visual imagery levels
    Description
    The Kinesthetic and Visual Imagery Questionnaire- KVIQ-20 will be used to assess the kinesthetic and visual imagery levels of healthy and physically disabled individuals.The questionnaire contains a total of 20 titles, 10 of which are visual and 10 of which are kinesthetic. The intensity level of imagery is recorded on a 5-point Likert scale with the questionnaire (5 = appearance of a live image; 1 = no image or sensation).
    Time Frame
    1 week before surgery and week 8 after surgery
    Title
    Change of Kinesiophobia
    Description
    Kinesiophobia was evaluated with Tampa Scale of Kinesiophobia (TSK).TSK is a 17-question checklist. The scale employs a 4-point Likert scoring system (1= strongly disagree, 4= completely agree).
    Time Frame
    1 week before surgery and week 8 after surgery
    Title
    Change of Patient Satisfaction
    Description
    A Numerical Evaluation Scale will be used to evaluate a 2-question satisfaction questionnaire. This scale is made up of a horizontal straight line 10 cm long. The line has a value of 0 at the start and a value of 10 at the end, from left to right. On a scale of 0 to 10, patients will be asked to rate their level of satisfaction.
    Time Frame
    1 week before surgery and week 8 after surgery
    Secondary Outcome Measure Information:
    Title
    Descriptive Information
    Description
    Age, gender, dominant hand, previous diseases, occupation and contact information of the patients were recorded in the descriptive information form.
    Time Frame
    1 week before surgery
    Title
    Change in Pain-Visual analog scale
    Description
    Pain of patients during sleep, rest and activity will evaluate using a visual analog scale (VAS).This scale is made up of a 10 cm horizontal straight line. When viewed from left to right, a 0 at the start of the line indicates no pain, and a 10 at the end indicates severe pain.
    Time Frame
    1 week before surgery, week 4 and week 8 after surgery
    Title
    Change of Range of Motion
    Description
    The limitation of shoulder joint flexion, extension, abduction, adduction, internal and external rotation movements will be measured using a universal goniometer and recorded in degrees(˚).
    Time Frame
    1 week before surgery, week 4 and week 8 after surgery
    Title
    Change in muscle atrophy
    Description
    For changes in muscle atrophy, circumference measurements (one of Anthropometric measurements) will be used.
    Time Frame
    1 week before surgery and week 8 after surgery

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    20 Years
    Maximum Age & Unit of Time
    65 Years
    Accepts Healthy Volunteers
    Accepts Healthy Volunteers
    Eligibility Criteria
    Inclusion Criteria: Ability to speak and understand Turkish - Previous arthroscopic rotator cuff repair Achieving a minimum of 40 points on the Kinesthetic and Visual Imagery Questionnaire -20 (KGIA-20) Access to adequate technological devices for communication and follow-up Exclusion Criteria: Who with neurological diseases that may cause functional impairment. Patients who have another shoulder problem and/or have had previous shoulder surgery on the same upper extremity. Who wanted to leave the study at their own request Who could not continue to work due to any additional discomfort developed
    Central Contact Person:
    First Name & Middle Initial & Last Name or Official Title & Degree
    Özüm ÇETİNKAYA EREN, PT, MSc
    Phone
    +905068794804
    Email
    ozum.eren@alanya.edu.tr
    First Name & Middle Initial & Last Name or Official Title & Degree
    Ummuhan BAŞ ASLAN, Prof.Dr.PT.
    Phone
    +905354510955
    Email
    umbaslan@yahoo.com
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    Özüm ÇETİNKAYA EREN, PT, MSc
    Organizational Affiliation
    Alanya Alaaddin Keykubat University
    Official's Role
    Principal Investigator
    First Name & Middle Initial & Last Name & Degree
    Ummuhan BAŞ ASLAN, Prof.Dr.PT.
    Organizational Affiliation
    Pamukkale University
    Official's Role
    Study Director
    First Name & Middle Initial & Last Name & Degree
    Kazım Emre EREN, PT, MSc
    Organizational Affiliation
    Alanya Alaaddin Keykubat University Hospital
    Official's Role
    Study Chair
    First Name & Middle Initial & Last Name & Degree
    Anıl GÜLCÜ, Asst.Prof.Dr
    Organizational Affiliation
    Alanya Alaaddin Keykubat University
    Official's Role
    Study Chair
    First Name & Middle Initial & Last Name & Degree
    Erdem DEMİR, Asst.Prof.Dr
    Organizational Affiliation
    Alanya Hamdullah Emin Paşa University
    Official's Role
    Study Chair

    12. IPD Sharing Statement

    Plan to Share IPD
    No
    Citations:
    PubMed Identifier
    32003812
    Citation
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    Results Reference
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    PubMed Identifier
    18819106
    Citation
    Guillot A, Collet C, Nguyen VA, Malouin F, Richards C, Doyon J. Brain activity during visual versus kinesthetic imagery: an fMRI study. Hum Brain Mapp. 2009 Jul;30(7):2157-72. doi: 10.1002/hbm.20658.
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    PubMed Identifier
    22787063
    Citation
    Boden-Albala B, Roberts ET, Bazil C, Moon Y, Elkind MS, Rundek T, Paik MC, Sacco RL. Daytime sleepiness and risk of stroke and vascular disease: findings from the Northern Manhattan Study (NOMAS). Circ Cardiovasc Qual Outcomes. 2012 Jul 1;5(4):500-7. doi: 10.1161/CIRCOUTCOMES.111.963801. Epub 2012 Jul 10.
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    Citation
    Chholak P, Niso G, Maksimenko VA, Kurkin SA, Frolov NS, Pitsik EN, Hramov AE, Pisarchik AN. Visual and kinesthetic modes affect motor imagery classification in untrained subjects. Sci Rep. 2019 Jul 8;9(1):9838. doi: 10.1038/s41598-019-46310-9.
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    Citation
    Hayes K, Walton JR, Szomor ZR, Murrell GA. Reliability of five methods for assessing shoulder range of motion. Aust J Physiother. 2001;47(4):289-94. doi: 10.1016/s0004-9514(14)60274-9.
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    Matlak S, Andrews A, Looney A, Tepper KB. Postoperative Rehabilitation of Rotator Cuff Repair: A Systematic Review. Sports Med Arthrosc Rev. 2021 Jun 1;29(2):119-129. doi: 10.1097/JSA.0000000000000310.
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