Clinical trial NCT05670080: 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
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: Rotator Cuff Tears
Motor Imagery
Muscle Activity
Atrophy, Muscular
Patient Satisfaction
Kinesiophobia
Shoulder Pain
Keywords: Motor Imagery
Muscle Activity
Muscular Atrophy
Rotator Cuff Tears
Lead sponsor: Alanya Alaaddin Keykubat University
Sponsor class: OTHER
Collaborators: name: Pamukkale University
name: Alanya Allaaddin Keykubat University Hospital
name: Alanya Hamdullah Emin Pasha University
First posted: 2023-01-04
Enrollment: 36
Sex: ALL
Minimum age (years): 20
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention 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.
Primary purpose: SUPPORTIVE_CARE

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.

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

Primary outcomes:
measure: Change of Muscle activity
timeFrame: 1 week before surgery and week 8 after surgery
measure: Change of shoulder functional level
timeFrame: 1 week before surgery and week 8 after surgery
measure: Change of Kinesthetic and visual imagery levels
timeFrame: 1 week before surgery and week 8 after surgery
measure: Change of Kinesiophobia
timeFrame: 1 week before surgery and week 8 after surgery
measure: Change of Patient Satisfaction
timeFrame: 1 week before surgery and week 8 after surgery
Secondary outcomes:
measure: Descriptive Information
timeFrame: 1 week before surgery
measure: Change in Pain-Visual analog scale
timeFrame: 1 week before surgery, week 4 and week 8 after surgery
measure: Change of Range of Motion
timeFrame: 1 week before surgery, week 4 and week 8 after surgery
measure: Change in muscle atrophy
timeFrame: 1 week before surgery and week 8 after surgery
Other outcomes:
Locations:
Study officials:
affiliation: Alanya Alaaddin Keykubat University
name: Özüm ÇETİNKAYA EREN, PT, MSc
role: PRINCIPAL_INVESTIGATOR
affiliation: Pamukkale University
name: Ummuhan BAŞ ASLAN, Prof.Dr.PT.
role: STUDY_DIRECTOR
affiliation: Alanya Alaaddin Keykubat University Hospital
name: Kazım Emre EREN, PT, MSc
role: STUDY_CHAIR
affiliation: Alanya Alaaddin Keykubat University
name: Anıl GÜLCÜ, Asst.Prof.Dr
role: STUDY_CHAIR
affiliation: Alanya Hamdullah Emin Paşa University
name: Erdem DEMİR, Asst.Prof.Dr
role: STUDY_CHAIR
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