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

Primary Purpose

Shoulder Pain

Status
Unknown status
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Motor Imaginery and Action Observation
Sponsored by
Universidad Autonoma de Madrid
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Shoulder Pain focused on measuring Motor Imaginery, Shoulder Pain, Chronic Pain, Prehabilitation

Eligibility Criteria

18 Years - 75 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    Experimental

    No Intervention

    Arm Label

    Motor Imaginery

    Control Group

    Arm Description

    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

    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.

    Outcomes

    Primary Outcome Measures

    Pain Intensity
    Pain Intensity with Visual Analogue Scale (range: 0-10). Higher scores mean more intensity
    Change in Pain Intensity
    Pain Intensity with Visual Analogue Scale (range: 0-10). Higher scores mean more intensity
    Change in Pain Intensity
    Pain Intensity with Visual Analogue Scale (range: 0-10). Higher scores mean more intensity
    Change in Pain Intensity
    Pain Intensity with Visual Analogue Scale (range: 0-10). Higher scores mean more intensity

    Secondary Outcome Measures

    Shoulder Disability: SPADI questionnaire
    Shoulder Disability with SPADI questionnaire (range: 0-100). Higher scores mean more disability
    Change in Shoulder Disability
    Shoulder Disability with SPADI questionnaire (range: 0-100). Higher scores mean more disability
    Health Related Quality of Live
    Health Related Quality of Live with EuroQoL-5D-5L (range 11111 - 55555). Higher scores mean worst Quality of Life
    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
    Pain Catastrophizing
    Pain Catastrophizing with Pain Catastrophizing Scale (range 0-52). Higher scores mean more catastrophizing
    Change in Pain Catastrophizing
    Pain Catastrophizing with Pain Catastrophizing Scale (range 0-52). Higher scores mean more Catastrophizing
    Pain Severity
    Pain Severity with Graded Chonic Pain Scale (rango 0-70). Higher scores mean more severity
    Change in Pain Severity
    Pain Severity with Graded Chonic Pain Scale (rango 0-70). Higher scores mean more severity
    Change Perception
    Change Perception with Global Rating of Change Scale (range -5 to + 5). - 5 means worst than before and +5 means Completely recovered

    Full Information

    First Posted
    October 3, 2019
    Last Updated
    March 23, 2020
    Sponsor
    Universidad Autonoma de Madrid
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    1. Study Identification

    Unique Protocol Identification Number
    NCT04118439
    Brief Title
    Effectiveness of Motor Imagery Intervention for Chronic Painful Shoulder in Primary Care
    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
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    March 2020
    Overall Recruitment Status
    Unknown status
    Study Start Date
    October 2020 (Anticipated)
    Primary Completion Date
    October 2021 (Anticipated)
    Study Completion Date
    May 2022 (Anticipated)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Principal Investigator
    Name of the Sponsor
    Universidad Autonoma de Madrid

    4. Oversight

    Studies a U.S. FDA-regulated Drug Product
    No
    Studies a U.S. FDA-regulated Device Product
    No

    5. Study Description

    Brief 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.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Shoulder Pain
    Keywords
    Motor Imaginery, Shoulder Pain, Chronic Pain, Prehabilitation

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Not Applicable
    Interventional Study Model
    Parallel Assignment
    Model Description
    Randomized Clinical Trial
    Masking
    ParticipantCare ProviderOutcomes Assessor
    Allocation
    Randomized
    Enrollment
    66 (Anticipated)

    8. Arms, Groups, and Interventions

    Arm Title
    Motor Imaginery
    Arm Type
    Experimental
    Arm Description
    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
    Arm Title
    Control Group
    Arm Type
    No Intervention
    Arm Description
    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.
    Intervention Type
    Other
    Intervention Name(s)
    Motor Imaginery and Action Observation
    Intervention Description
    A set of tasks done with the shoulder, first with an Action Observation perspective and then asked to perform this tasks with motor imaginery
    Primary Outcome Measure Information:
    Title
    Pain Intensity
    Description
    Pain Intensity with Visual Analogue Scale (range: 0-10). Higher scores mean more intensity
    Time Frame
    Previous the intervention
    Title
    Change in Pain Intensity
    Description
    Pain Intensity with Visual Analogue Scale (range: 0-10). Higher scores mean more intensity
    Time Frame
    At 30 days from the begining finishing the intervention
    Title
    Change in Pain Intensity
    Description
    Pain Intensity with Visual Analogue Scale (range: 0-10). Higher scores mean more intensity
    Time Frame
    At the end of the usual care period of 4 weeks
    Title
    Change in Pain Intensity
    Description
    Pain Intensity with Visual Analogue Scale (range: 0-10). Higher scores mean more intensity
    Time Frame
    Up to 12 weeks
    Secondary Outcome Measure Information:
    Title
    Shoulder Disability: SPADI questionnaire
    Description
    Shoulder Disability with SPADI questionnaire (range: 0-100). Higher scores mean more disability
    Time Frame
    Previous the intervention
    Title
    Change in Shoulder Disability
    Description
    Shoulder Disability with SPADI questionnaire (range: 0-100). Higher scores mean more disability
    Time Frame
    Up to 12 weeks
    Title
    Health Related Quality of Live
    Description
    Health Related Quality of Live with EuroQoL-5D-5L (range 11111 - 55555). Higher scores mean worst Quality of Life
    Time Frame
    Previous the intervention
    Title
    Change in Health Related Quality of Live
    Description
    Health Related Quality of Live with EuroQoL-5D-5L (range 11111 - 55555). Higher scores mean worst Quality of Life
    Time Frame
    Up to 12 weeks
    Title
    Pain Catastrophizing
    Description
    Pain Catastrophizing with Pain Catastrophizing Scale (range 0-52). Higher scores mean more catastrophizing
    Time Frame
    Previous the intervention
    Title
    Change in Pain Catastrophizing
    Description
    Pain Catastrophizing with Pain Catastrophizing Scale (range 0-52). Higher scores mean more Catastrophizing
    Time Frame
    Up to 12 weeks
    Title
    Pain Severity
    Description
    Pain Severity with Graded Chonic Pain Scale (rango 0-70). Higher scores mean more severity
    Time Frame
    Previous the intervention
    Title
    Change in Pain Severity
    Description
    Pain Severity with Graded Chonic Pain Scale (rango 0-70). Higher scores mean more severity
    Time Frame
    Up to 12 weeks
    Title
    Change Perception
    Description
    Change Perception with Global Rating of Change Scale (range -5 to + 5). - 5 means worst than before and +5 means Completely recovered
    Time Frame
    At 12 weeks from the end of the intervention

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    18 Years
    Maximum Age & Unit of Time
    75 Years
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    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.

    12. IPD Sharing Statement

    Plan to Share IPD
    No
    Citations:
    PubMed Identifier
    15163107
    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. doi: 10.1080/03009740310004667.
    Results Reference
    background
    PubMed Identifier
    11125006
    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. doi: 10.1523/JNEUROSCI.20-24-09277.2000.
    Results Reference
    background
    PubMed Identifier
    27917103
    Citation
    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.
    Results Reference
    background

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

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