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

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

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.

Study Overview

• Status: Unknown
• Conditions: Shoulder Pain
• Intervention / Treatment: Other: Motor Imaginery and Action Observation

• Study Type: Interventional
• Enrollment (Anticipated): 66
• Phase: Not Applicable

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 75 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

1. 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,
2. who have not received physiotherapy treatment by the same process in the last 6 months.

Exclusion Criteria:

1. suffer from systemic diseases such as rheumatoid arthritis, fibromyalgia, diagnosed neurological disease, lupus erythematosus, or cancer.
2. History of shoulder surgery,
3. patients with psychiatric pathologies or personality disorders;
4. 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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Triple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Motor Imaginery; 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; A set of tasks done with the shoulder, first with an Action Observation perspective and then asked to perform this tasks with motor imaginery
No Intervention: Control Group; 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?

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

Collaborators and Investigators

• Sponsor: Universidad Autonoma de Madrid

Publications and helpful links

General Publications

• Luime JJ, Koes BW, Hendriksen IJ, Burdorf A, Verhagen AP, Miedema HS, Verhaar JA. Prevalence and incidence of shoulder pain in the general population; a systematic review. Scand J Rheumatol. 2004;33(2):73-81. doi: 10.1080/03009740310004667.
• Tinazzi M, Fiaschi A, Rosso T, Faccioli F, Grosslercher J, Aglioti SM. Neuroplastic changes related to pain occur at multiple levels of the human somatosensory system: A somatosensory-evoked potentials study in patients with cervical radicular pain. J Neurosci. 2000 Dec 15;20(24):9277-83. doi: 10.1523/JNEUROSCI.20-24-09277.2000.
• Eaves DL, Riach M, Holmes PS, Wright DJ. Motor Imagery during Action Observation: A Brief Review of Evidence, Theory and Future Research Opportunities. Front Neurosci. 2016 Nov 21;10:514. doi: 10.3389/fnins.2016.00514. eCollection 2016.

Study record dates

Study Major Dates

• Study Start (Anticipated): October 1, 2020
• Primary Completion (Anticipated): October 1, 2021
• Study Completion (Anticipated): May 1, 2022

Study Registration Dates

• First Submitted: October 3, 2019
• First Submitted That Met QC Criteria: October 4, 2019
• First Posted (Actual): October 8, 2019

Study Record Updates

• Last Update Posted (Actual): March 25, 2020
• Last Update Submitted That Met QC Criteria: March 23, 2020
• Last Verified: March 1, 2020

More Information

Terms related to this study

• Keywords: Chronic Pain; Shoulder Pain; Motor Imaginery; Prehabilitation
• Additional Relevant MeSH Terms: Pain; Neurologic Manifestations; Joint Diseases; Musculoskeletal Diseases; Arthralgia; Shoulder Pain
• Other Study ID Numbers: 201936043

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No