Effect of Graded Motor Imagery in Impingement

NCT ID: NCT06865001

Last Updated: 2025-03-12

Basic Information

• Recruitment Status: ACTIVE_NOT_RECRUITING
• Clinical Phase: NA
• Total Enrollment: 30 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2024-01-12
• Study Completion Date: 2025-07-30

Brief Summary

Purpose: This randomized controlled trial aims to investigate the effects of Graded Motor Imagery (GMI) added to conventional physiotherapy in patients with Grade-2 shoulder impingement syndrome. The primary objectives are to evaluate the impact of GMI on pain intensity, range of motion, kinesiophobia, joint position sense, and quality of life. The hypotheses tested are:

H0: GMI combined with conventional therapy has no effect on the aforementioned outcomes.

H1: GMI combined with conventional therapy significantly improves these outcomes.

Methodology: The study will include 30 participants (15 control, 15 intervention) diagnosed with Grade-2 shoulder impingement, recruited from a tertiary hospital. Participants will be randomly allocated into two groups:

Control Group: Receives 15 sessions of conventional physiotherapy (ultrasound, TENS, hotpack, and therapeutic exercises).

Intervention Group: Receives conventional therapy plus GMI, which includes three phases: (1) lateralization training (identifying left/right limb images), (2) motor imagery (mental rehearsal of functional movements), and (3) mirror therapy (visual feedback via mirror).

Outcome measures include pain (Visual Analog Scale), range of motion (digital goniometer), joint position sense (mobile app-based assessment), kinesiophobia (Tampa Scale), upper extremity function (DASH questionnaire), and quality of life (SF-36). Pre- and post-intervention evaluations will be conducted.

Detailed Description

Purpose:

This study is designed as a randomized controlled trial to evaluate the effectiveness of Graded Motor Imagery (GMI) as an adjunct to conventional physiotherapy in patients diagnosed with Grade-2 shoulder impingement syndrome. The primary aim is to assess the impact of GMI on several key outcomes, including pain intensity, range of motion, kinesiophobia (fear of movement), joint position sense, and quality of life. The study is motivated by the need to explore innovative rehabilitation techniques that address both the physical and neurological aspects of shoulder impingement syndrome, particularly in cases where conventional treatments may not yield optimal results.

The study is guided by two hypotheses:

Null Hypothesis (H0): The addition of GMI to conventional physiotherapy has no significant effect on pain, range of motion, kinesiophobia, joint position sense, or quality of life in patients with Grade-2 shoulder impingement syndrome.

Alternative Hypothesis (H1): The addition of GMI to conventional physiotherapy significantly improves pain, range of motion, kinesiophobia, joint position sense, and quality of life in these patients.

Methodology:

The study will be conducted at a tertiary hospital, with a sample size of 30 participants (15 in the control group and 15 in the intervention group). Participants will be recruited from patients diagnosed with Grade-2 shoulder impingement syndrome who meet the inclusion criteria, which include being between 18-65 years old, having a confirmed diagnosis, and being willing to participate in the study. Exclusion criteria include a history of upper extremity surgery, acute infections, or chronic neurological, psychiatric, or orthopedic conditions that could interfere with the study.

Participants will be randomly assigned to one of two groups using a simple randomization method:

Control Group: This group will receive 15 sessions of conventional physiotherapy, which includes modalities such as ultrasound, TENS (transcutaneous electrical nerve stimulation), hotpack application, and therapeutic exercises targeting shoulder mobility, strength, and stability.

Intervention Group: In addition to the conventional physiotherapy, this group will undergo a structured GMI program. The GMI protocol consists of three progressive phases:

Lateralization Training: Participants will be shown images of limbs and asked to quickly identify whether they are left or right. This phase aims to improve the brain's ability to distinguish between the affected and unaffected limbs.

Motor Imagery: Participants will mentally rehearse specific functional movements (e.g., combing hair, reaching for a cup) without physically performing them. This phase activates the premotor and primary motor cortices, helping to rewire the brain's motor pathways.

Mirror Therapy: A mirror will be used to create a visual illusion of the affected limb moving normally by reflecting the unaffected limb. This phase provides visual feedback to the brain, promoting cortical reorganization and reducing pain perception.

Outcome Measures:

The study will evaluate the following outcomes before and after the intervention:

Pain Intensity: Measured using the Visual Analog Scale (VAS), where 0 indicates no pain and 10 indicates the worst pain imaginable.

Range of Motion: Assessed using a digital goniometer to measure shoulder flexion, extension, abduction, and internal/external rotation.

Kinesiophobia: Evaluated using the Tampa Scale for Kinesiophobia, which measures fear of movement and re-injury.

Joint Position Sense: Assessed using a mobile app-based method, where participants will position their shoulder at specific angles with eyes closed, and deviations from the target angle will be recorded.

Quality of Life: Measured using the SF-36 Health Survey, which evaluates physical and mental health across eight domains.

Upper Extremity Function: Assessed using the Disabilities of the Arm, Shoulder, and Hand (DASH) questionnaire, which evaluates the impact of shoulder pathology on daily activities.

Statistical Analysis:

Data will be analyzed using IBM SPSS Statistics (Version 23.0). The Shapiro-Wilk test will be used to check for normal distribution of data. For normally distributed data, parametric tests such as paired t-tests (for within-group comparisons) and unpaired t-tests (for between-group comparisons) will be used. For non-normally distributed data, non-parametric tests such as the Wilcoxon signed-rank test (within-group) and Mann-Whitney U test (between-group) will be applied. The significance level will be set at p < 0.05.

Expected Contributions:

This study aims to provide high-quality evidence on the effectiveness of GMI as an adjunct to conventional physiotherapy in the treatment of Grade-2 shoulder impingement syndrome. By exploring the impact of GMI on both physical and neurological outcomes, the study seeks to contribute to the development of more comprehensive rehabilitation protocols that address the multifaceted nature of chronic shoulder pain and dysfunction. The findings may also offer insights into the potential of GMI for other chronic pain conditions, paving the way for further research in this area.

Conclusion:

This randomized controlled trial represents a significant step forward in understanding the role of GMI in the rehabilitation of shoulder impingement syndrome. By integrating conventional physiotherapy with advanced neurorehabilitation techniques, the study aims to improve patient outcomes and enhance the quality of life for individuals suffering from this debilitating condition.

Conditions

Shoulder; Impingement Syndrome; Pain

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

Intervention

For patients diagnosed with shoulder impingemet, graded motor imagery will be applied in addition to 15 sessions of conventional treatment.

Group Type: OTHER

Conventional treatment

Intervention Type: OTHER

Ultrasound, hotpack and TENS will be applied to both control and study groups as physical therapy modality. Then 15 sessions of Codman exercises, normal range of motion exercises and stretching exercises will be applied to both groups.

Graded motor imagery

Intervention Type: OTHER

Graded motor imagery consists of three stages:

1. limb lateralization task

2. an imaginary limb movement task (motor imagery) and

3. mirror therapy. Each session will consist of 12-15 minutes and 3 sets, with 5 minutes between sessions to rest and relax the limb. The application is planned for 30 minutes.

Control

Patients diagnosed with shoulder impingemet will receive 15 sessions of conventional treatment.

Group Type: OTHER

Conventional treatment

Intervention Type: OTHER

Ultrasound, hotpack and TENS will be applied to both control and study groups as physical therapy modality. Then 15 sessions of Codman exercises, normal range of motion exercises and stretching exercises will be applied to both groups.

Interventions

Conventional treatment

Ultrasound, hotpack and TENS will be applied to both control and study groups as physical therapy modality. Then 15 sessions of Codman exercises, normal range of motion exercises and stretching exercises will be applied to both groups.

Intervention Type: OTHER

Graded motor imagery

Graded motor imagery consists of three stages:

1. limb lateralization task

2. an imaginary limb movement task (motor imagery) and

3. mirror therapy. Each session will consist of 12-15 minutes and 3 sets, with 5 minutes between sessions to rest and relax the limb. The application is planned for 30 minutes.

Intervention Type: OTHER

Eligibility Criteria

Inclusion Criteria

• To be between the ages of 18-65,
• Volunteering to participate in the study,
• Diagnosed with Grade-2 shoulder impingement.

Exclusion Criteria

• Not volunteering to participate in the study,
• Having undergone upper extremity surgery,
• History of previous shoulder surgery, shoulder subluxation or dislocation,
• Any mental or sensory problems,
• Acute infection or chronic disease of neurological, psychiatric, orthopedic, cardiological, rheumatological, etc. origin.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 65 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Bandırma Onyedi Eylül University

OTHER

Sponsor Role: lead

Responsible Party

Burçin Akçay

Associate Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

Bandırma Onyedi Eylül University Faculty of Health Sciences Department of Physiotherapy and Rehabilitation,

Balıkesir, Bandırma, Turkey (Türkiye)

Countries

Turkey (Türkiye)

Other Identifiers

motor imagenaryfor Inpingement

Identifier Type: -

Identifier Source: org_study_id