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

Shoulder Pain Clinical Trial

Official title:

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT04118439
• Other study ID #: 201936043
• Status: Not yet recruiting
• Phase: N/A
• Start date: October 2020
• Est. completion date: May 2022

Study information

• Verified date: March 2020
• Source: Universidad Autonoma de Madrid
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 66
• Est. completion date: May 2022
• Est. primary completion date: October 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 75 Years

Eligibility

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.

Related Conditions & MeSH terms

• Shoulder Pain

Intervention

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

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Universidad Autonoma de Madrid

References & Publications (3)

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. eCollection 2016. Review. — View Citation

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. Review. — View Citation

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Pain Intensity	Pain Intensity with Visual Analogue Scale (range: 0-10). Higher scores mean more intensity	Previous the intervention
Primary	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
Primary	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
Primary	Change in Pain Intensity	Pain Intensity with Visual Analogue Scale (range: 0-10). Higher scores mean more intensity	Up to 12 weeks
Secondary	Shoulder Disability: SPADI questionnaire	Shoulder Disability with SPADI questionnaire (range: 0-100). Higher scores mean more disability	Previous the intervention
Secondary	Change in Shoulder Disability	Shoulder Disability with SPADI questionnaire (range: 0-100). Higher scores mean more disability	Up to 12 weeks
Secondary	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
Secondary	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
Secondary	Pain Catastrophizing	Pain Catastrophizing with Pain Catastrophizing Scale (range 0-52). Higher scores mean more catastrophizing	Previous the intervention
Secondary	Change in Pain Catastrophizing	Pain Catastrophizing with Pain Catastrophizing Scale (range 0-52). Higher scores mean more Catastrophizing	Up to 12 weeks
Secondary	Pain Severity	Pain Severity with Graded Chonic Pain Scale (rango 0-70). Higher scores mean more severity	Previous the intervention
Secondary	Change in Pain Severity	Pain Severity with Graded Chonic Pain Scale (rango 0-70). Higher scores mean more severity	Up to 12 weeks
Secondary	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