- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT06865001
Effect of Graded Motor Imagery in Impingement (Impingement)
The Effect of Graded Motor Imagery on Pain, Range of Motion, Kinesiophobia, Position Sense and Quality of Life in Shoulder Impingement Syndrome
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.
Study Overview
Status
Conditions
Intervention / Treatment
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.
Study Type
Enrollment (Estimated)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
Bandırma
-
Balıkesir, Bandırma, Turkey
- Bandırma Onyedi Eylül University Faculty of Health Sciences Department of Physiotherapy and Rehabilitation,
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
Description
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.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Other: Intervention
For patients diagnosed with shoulder impingemet, graded motor imagery will be applied in addition to 15 sessions of 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.
Graded motor imagery consists of three stages:
|
|
Other: Control
Patients diagnosed with shoulder impingemet will receive 15 sessions of 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.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Visual Analogue Scale
Time Frame: 3 weeks
|
In this study, the severity of shoulder pain will be evaluated with the Visual Analogue Scale.
According to the VAS, pain intensity is graded as "no pain" 0 points and "worst unbearable pain" 10 points (10 cm scale).
|
3 weeks
|
|
Range of motion
Time Frame: 3 weeks
|
In the study, a digital goniometer, which has been validated and reliable, was used to objectively evaluate the normal range of motion of the shoulder.
Normal range of motion of the shoulder will be evaluated by measuring the range of motion of shoulder flexion, extension, abduction, internal rotation and external rotation movements.
|
3 weeks
|
|
Joint position sense
Time Frame: 3 weeks
|
In this study, using this mobile application, the patient will perform 50-70-90 and 110 degrees of shoulder flexion with eyes open.
Then, the patient will be asked to position the arm at the same angles with the eyes closed.
Then the degrees of deviation will be calculated.
|
3 weeks
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
The Short Form-36 Quality of Life Questionnaire
Time Frame: 3 weeks
|
The Short Form-36, frequently used to assess quality of life, will be used.
SF-36 consists of eight subscales including physical function, physical role, emotional function, social function, general health, mental health, pain and wellness.
Each subscale scores between 0-100, and the scale is directly proportional to quality of life.
A score of 100 indicates the best health status and a score of 0 indicates the worst health status.
|
3 weeks
|
|
Disabilities of the Arm, Shoulder and Hand Questionnaire (DASH):
Time Frame: 3 weeks
|
The validity of this questionnaire has been reported to be high in studies on the shoulder, elbow and wrist in the literature.
It consists of 30 questions assessing the degree of difficulty in performing different activities in which the upper extremity is used in daily life in the last 1 week (21 questions), symptoms consisting of pain, activity-related pain, numbness, joint stiffness and weakness (5 questions), and the effects of pathologies on social life, sleep, work and psychological status (4 questions).
|
3 weeks
|
|
TAMPA Kinesiophobia Scale
Time Frame: 3 weeks
|
It is a 17-question scale developed to measure fear of movement/reinjury.
The scale includes parameters of injury/re-injury and fear-avoidance in work-related activities.
|
3 weeks
|
Collaborators and Investigators
Sponsor
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Estimated)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- motor imagenaryfor Inpingement
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
product manufactured in and exported from the U.S.
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