Effectiveness of Motor Imagery Intervention for Chronic Painful Shoulder in Primary Care

Study Overview
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Brief Summary
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Objective: to evaluate the effectiveness of an intervention with observed actions and motor imagery, through self-treatment at home, in the improvement of perceived disability, pain intensity and quality of life in patients with chronic painful shoulder (CPS). Design: multicenter randomized controlled trial of parallel groups, single blind controlled, carried out in the Community of Madrid. Population: patients between 18-65 years of age with CPS who come to physical therapy consultation at the Primary Health Centers of the Community of Madrid. N = 66 (33 in each branch). Control group: usual practice standardized in the Primary Heal Physical Therapy Services Community of Madrid. Experimental group: intervention with observed actions and motor imagery, which will perform in a graduated way the patient in his home through the application MIRROR THERAPY VR, in addition to the usual practice. Variable main result: Intensity of Pain. Secondary variables: sociodemographic, sensorimotor, quality of motor imagery, psychosocial (perceived disability, catastrophism, kinesiophobia, Anxiety / depression) and quality of life. Analysis: by intention to treat, comparing the Pain Intensity score before / after the intervention in both groups at 1 and 3 months of intervention.

Official Title
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Effectiveness of a Home-based Self-treatment Programme at the Start of Physiotherapy Treatment Using Motor Imagery and Visualisation in Patients With Painful Shoulder

Conditions
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Shoulder Pain

Intervention / Treatment
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* Other: Motor Imaginery and Action Observation


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: who have been diagnosed and referred by the family physician to physiotherapy units in primary care by a process of muscular origin in the shoulder region, who have not received physiotherapy treatment by the same process in the last 6 months. Exclusion Criteria: suffer from systemic diseases such as rheumatoid arthritis, fibromyalgia, diagnosed neurological disease, lupus erythematosus, or cancer. History of shoulder surgery, patients with psychiatric pathologies or personality disorders; patients with severe mobility limitation compatible with the diagnosis of frozen shoulder, 5) patients diagnosed with type II diabetes, 6) patients with little knowledge of Spanish language spoken or written and 7) reproduction of symptoms during active movements of the cervical spine or during palpation of the cervical or thoracic region.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 75 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: Randomized Clinical Trial
Masking: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Motor Imaginery<br>Patients allocated in this arm will recieve a training on the first day after recruitment on a motor imaginery task and will be asked to do the task every day during 30 days until they start the usual care. Then after the physical therapy treatment with a pragmatic perspective will be meassured just inthe last session, after 1 month an.d after 3 moths of the treatment for the follow up | Other: Motor Imaginery and Action Observation<br>* A set of tasks done with the shoulder, first with an Action Observation perspective and then asked to perform this tasks with motor imaginery<br>|
| No Intervention: Control Group<br>Patients allocated in this arm will be meassured at the start, again after 30 days and at the end of the physical therapy usual care with a pragmatic perspective. Then will be meassured again after 1 and 3 months. | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Pain Intensity | Pain Intensity with Visual Analogue Scale (range: 0-10). Higher scores mean more intensity | Previous the intervention | 
| Change in Pain Intensity | Pain Intensity with Visual Analogue Scale (range: 0-10). Higher scores mean more intensity | At 30 days from the begining finishing the intervention | 
| Change in Pain Intensity | Pain Intensity with Visual Analogue Scale (range: 0-10). Higher scores mean more intensity | At the end of the usual care period of 4 weeks | 
| Change in Pain Intensity | Pain Intensity with Visual Analogue Scale (range: 0-10). Higher scores mean more intensity | Up to 12 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Shoulder Disability: SPADI questionnaire | Shoulder Disability with SPADI questionnaire (range: 0-100). Higher scores mean more disability | Previous the intervention | 
| Change in Shoulder Disability | Shoulder Disability with SPADI questionnaire (range: 0-100). Higher scores mean more disability | Up to 12 weeks | 
| Health Related Quality of Live | Health Related Quality of Live with EuroQoL-5D-5L (range 11111 - 55555). Higher scores mean worst Quality of Life | Previous the intervention | 
| Change in Health Related Quality of Live | Health Related Quality of Live with EuroQoL-5D-5L (range 11111 - 55555). Higher scores mean worst Quality of Life | Up to 12 weeks | 
| Pain Catastrophizing | Pain Catastrophizing with Pain Catastrophizing Scale (range 0-52). Higher scores mean more catastrophizing | Previous the intervention | 
| Change in Pain Catastrophizing | Pain Catastrophizing with Pain Catastrophizing Scale (range 0-52). Higher scores mean more Catastrophizing | Up to 12 weeks | 
| Pain Severity | Pain Severity with Graded Chonic Pain Scale (rango 0-70). Higher scores mean more severity | Previous the intervention | 
| Change in Pain Severity | Pain Severity with Graded Chonic Pain Scale (rango 0-70). Higher scores mean more severity | Up to 12 weeks | 
| Change Perception | Change Perception with Global Rating of Change Scale (range -5 to + 5). - 5 means worst than before and +5 means Completely recovered | At 12 weeks from the end of the intervention | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Motor Imaginery, Shoulder Pain, Chronic Pain, Prehabilitation