Graded Motor Imagery Training in Shoulder Impingement Syndrome

Not Applicable

Completed

• Conditions: Shoulder Impingement Syndrome; Pain
• Interventions: Other: Graded Motor Imagery (GMI) training; Other: Conventional Physiotherapy; Other: Home Exercise Program

• Registration Number: NCT06081088
• Lead Sponsor: Marmara University

Brief Summary

The aim of this study is to investigate the effects of Graded Motor Imagery (GMI) training on pain, functionality, disability and daily living activities in patients diagnosed with Shoulder Impingement Syndrome.

Detailed Description

In this study 42 voluntary patients with Shoulder Impingement Syndrome, aged between 25-65 years will be randomly divided into two groups; group1: "GMI + Conventional Physiotherapy", group 2: "Conventional Physiotherapy".

All participants will receive treatment with a physiotherapist three times a week for six-weeks (18 sessions). At the end of the 6th week, it will be followed regularly with a six-week home exercise program. It will be evaluated by a physiotherapist three times in total (before treatment, at the end of six-weeks of treatment and after six-weeks of follow-up). In addition, all patients will undergo an interim evaluation in terms of primary outcome measures (VAS and DASH score) at week three. The shoulder pain on activity, at rest and at night will be assessed with Visual Analog Scale (VAS), Joint Range of Motion (ROM) will be measured with digital goniometer, strength of shoulder flexor, abductor, external and internal rotator muscles will be assessed with digital dynamometer, functional status will be evaluated with Disabilities of the Arm, Shoulder and Hand (DASH) questionnaire, functional status of the hand will be evaluated with Jebsen-Taylor Hand Function Test (JTHFT), lateralization evaluation will be assessed with the Recognise™ application (Shoulder and Hand), and motor imagery will be evaluated with the Kinesthetic and Visual Imagery Questionnair (KVIQ). Patient satisfaction will be evaluated by the Global Rating of Change scale.

Study Timeline

• Status Verified: 2023-10
• Study First Submitted: 2023-10-02
• Study First Submitted QC: 2023-10-10
• Study First Posted: 2023-10-12
• Study Start: 2023-10-16
• Primary Completion: 2024-06-27
• Study Completion: 2024-06-27
• Last Update Submitted: 2024-06-27
• Last Update Posted: 2024-06-28

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 42

Inclusion Criteria

• Aged between 25-65 years old,
• Having been diagnosed with Shoulder Impingement Syndrome by physical examination and MRI as a result of shoulder pain lasting at least 3 months,
• Presence of a painful arc between 60° and 120° in shoulder flexion / abduction (elevation) movements,
• The Standardized Mini Mental Test result must be at least 24 points,
• Not having seen imagery practice before,

Exclusion Criteria

• Having severe mental and communication problems,
• Having undergone surgical treatment on the same upper extremity,
• Presence of acute trauma, peripheral nervous system lesion, fracture or complete tendon rupture in the affected shoulder,
• Presence of other pathologies such as adhesive capsulitis of the shoulder joint complex and glenohumeral instability,
• Presence of radiotherapy history on the same side as the affected shoulder,
• Presence of congenital deformity,
• Symptomatic cervical spine pathology,
• Presence of other neurological or rheumatological disorders affecting upper motor function,
• Having any chronic disease that would prevent participation in the treatment program,
• Having attended a physiotherapy program within the last month.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Group 1	Graded Motor Imagery (GMI) training	Study group: "Graded Motor Imagery Training + Conventional Physiotherapy" In this group, each participant will be received a treatment protocol consisting of Graded Motor Imagery training, conventional physiotherapy, and home exercises. * Graded Motor Imagery (GMI) * Conventional Physiotherapy Program * Home Exercise Program
Group 2	Home Exercise Program	Control group: "Conventional Physiotherapy" In this group, each participant will be received a treatment protocol consisting of conventional physiotherapy, and home exercises. * Conventional Physiotherapy Program * Home Exercise Program
Group 2	Conventional Physiotherapy	Control group: "Conventional Physiotherapy" In this group, each participant will be received a treatment protocol consisting of conventional physiotherapy, and home exercises. * Conventional Physiotherapy Program * Home Exercise Program
Group 1	Conventional Physiotherapy	Study group: "Graded Motor Imagery Training + Conventional Physiotherapy" In this group, each participant will be received a treatment protocol consisting of Graded Motor Imagery training, conventional physiotherapy, and home exercises. * Graded Motor Imagery (GMI) * Conventional Physiotherapy Program * Home Exercise Program
Group 1	Home Exercise Program	Study group: "Graded Motor Imagery Training + Conventional Physiotherapy" In this group, each participant will be received a treatment protocol consisting of Graded Motor Imagery training, conventional physiotherapy, and home exercises. * Graded Motor Imagery (GMI) * Conventional Physiotherapy Program * Home Exercise Program

Primary Outcome Measures

Name	Time	Method
Pain intensity	Baseline, Interim evaluation (At the end of the 3rd week), After the six-week intervention, After six-weeks of follow-up	Pain intensity will be assessed with Visual Analog Scale (VAS). The VAS is usually a horizontal line, 10 cm in length, anchored by word descriptors at each end with "No Pain" (score of zero) on the left side up to "pain as bad as it could be" or the "worst imaginable pain" (Score of 100 \[100-mm scale\]) on the right side.The patient will be asked to mark the line point that represented his or her current pain.
Functional Status	Baseline, Interim evaluation (At the end of the 3rd week), After the six-week intervention, After six-weeks of follow-up	The disabilities of the Arm, Shoulder and Hand (DASH) questionnaire will be used in shoulder functional status evaluation. The DASH consists mainly of a 30-item disability/symptom scale, scored 0 (no disability) to 100. 21 of the questions of the survey question the ability to perform functional activities, 5 question the pain, and 4 question the psychosocial effects of the disease. Each question is scored using a 5-point Likert scale ranging from 1 to 5 (1: no difficulty, 2: mild difficulty, 3: moderate difficulty, 4: extreme difficulty, 5: not at all). Higher scores indicate better functional status.

Secondary Outcome Measures

Name	Time	Method
Isometric Muscle Strength	Baseline, After the six-week intervention, After six-weeks of follow-up	Isometric muscle strength of shoulder flexor, abductor, external and internal rotator muscles will be evaluated with a hand-held dynamometer. During muscle strength evaluation, patients will be asked to perform maximal voluntary isometric contraction while in a sitting position. Measurements will be repeated 3 times (5 seconds of contraction followed by 30 seconds of rest) for the affected side and the average of the 3 measurements will be taken and the resulting value will be recorded in kilograms (kg).
Functional Status Of the Hand	Baseline, After the six-week intervention, After six-weeks of follow-up	Jebsen-Taylor Hand Function Test (JTHFT) will be used to evaluate the functional status of the hand. JTHFT is a standardized and objective measure of fine and gross motor hand function using simulated activities of daily living. The JTHFT has seven subsets which are writing, simulated page-turning, lifting small objects, simulated feeding, stacking, and lifting large, lightweight, and heavy objects. Time will be recorded in this test. Except for writing, other tasks are done separately with both hands. The completion time of the tasks refers to the subtask scores and total score of JTHFT. The total score is obtained by adding up the completion time of the six tasks other than writing for the dominant and non-dominant hands.
Active Range Of Motion (AROM)	Baseline, After the six-week intervention, After six-weeks of follow-up	A digital goniometer will be used to measure shoulder active joint range of motion. While the patient is lying in the supine position, shoulder active flexion, active abduction, and then shoulder internal (internal) and external (external) rotation ROM measurements will be made with the shoulder in 90 degrees abduction and the elbow in 90 degrees flexion.
Left/right discrimination (Lateralization)	Baseline, After the six-week intervention, After six-weeks of follow-up	Right-Left Discrimination will be evaluated with Recognise™ applications (Shoulder and Hand) developed by the "Neuro Orthopedic Institute".
Global Rating of Change scale (Patient Satisfaction)	After the six-week intervention	Patient satisfaction regarding improvement in shoulder function will be evulated by the Global Rating of Change scale. All participants will be asked to rate their condition after a six-week intervention period compared to baseline by indicating whether they have improved significantly, improved slightly, unchanged, deteriorated slightly, or deteriorated significantly in this study.
Kinesthetic and Visual Imagery Questionnaire (KVIQ)	Baseline, After the six-week intervention, After six-weeks of follow-up	Motor imagery ability will be assessed with the Kinesthetic and Visual Imagery Questionnaire (KVIQ). The participant gives a score between 1 and 5 for the image he/she imagines: "1 point: no image, 5 points: as clear as the original." This process is repeated for each task and at the end of the survey, kinesthetic imagery score, visual imagery score and total score are calculated.

Trial Locations

Locations (1)

Marmara University; 🇹🇷 Istanbul, Başıbüyük, Süreyyapaşa Başıbüyük Yolu Sk No:4/B, 34854 Maltepe, Turkey