Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu
Help guide our efforts to modernize ClinicalTrials.gov.
Send us your comments by March 14, 2020.

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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04118439
Recruitment Status : Not yet recruiting
First Posted : October 8, 2019
Last Update Posted : October 9, 2019
Sponsor:
Information provided by (Responsible Party):
Raúl Ferrer-Peña, Universidad Autonoma de Madrid

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.

Condition or disease Intervention/treatment Phase
Shoulder Pain Other: Motor Imaginery and Action Observation Not Applicable

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 66 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description: Randomized Clinical Trial
Masking: Triple (Participant, Care Provider, Outcomes Assessor)
Primary Purpose: Treatment
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
Estimated Study Start Date : January 2020
Estimated Primary Completion Date : October 2021
Estimated Study Completion Date : May 2022

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.



Primary Outcome Measures :
  1. Pain Intensity [ Time Frame: Previous the intervention ]
    Pain Intensity with Visual Analogue Scale (range: 0-10). Higher scores mean more intensity

  2. Change in Pain Intensity [ Time Frame: At 30 days from the begining finishing the intervention ]
    Pain Intensity with Visual Analogue Scale (range: 0-10). Higher scores mean more intensity

  3. Change in Pain Intensity [ Time Frame: At the end of the usual care period of 4 weeks ]
    Pain Intensity with Visual Analogue Scale (range: 0-10). Higher scores mean more intensity

  4. Change in Pain Intensity [ Time Frame: Up to 12 weeks ]
    Pain Intensity with Visual Analogue Scale (range: 0-10). Higher scores mean more intensity


Secondary Outcome Measures :
  1. Shoulder Disability: SPADI questionnaire [ Time Frame: Previous the intervention ]
    Shoulder Disability with SPADI questionnaire (range: 0-100). Higher scores mean more disability

  2. Change in Shoulder Disability [ Time Frame: Up to 12 weeks ]
    Shoulder Disability with SPADI questionnaire (range: 0-100). Higher scores mean more disability

  3. Health Related Quality of Live [ Time Frame: Previous the intervention ]
    Health Related Quality of Live with EuroQoL-5D-5L (range 11111 - 55555). Higher scores mean worst Quality of Life

  4. Change in Health Related Quality of Live [ Time Frame: Up to 12 weeks ]
    Health Related Quality of Live with EuroQoL-5D-5L (range 11111 - 55555). Higher scores mean worst Quality of Life

  5. Pain Catastrophizing [ Time Frame: Previous the intervention ]
    Pain Catastrophizing with Pain Catastrophizing Scale (range 0-52). Higher scores mean more catastrophizing

  6. Change in Pain Catastrophizing [ Time Frame: Up to 12 weeks ]
    Pain Catastrophizing with Pain Catastrophizing Scale (range 0-52). Higher scores mean more Catastrophizing

  7. Pain Severity [ Time Frame: Previous the intervention ]
    Pain Severity with Graded Chonic Pain Scale (rango 0-70). Higher scores mean more severity

  8. Change in Pain Severity [ Time Frame: Up to 12 weeks ]
    Pain Severity with Graded Chonic Pain Scale (rango 0-70). Higher scores mean more severity

  9. Change Perception [ Time Frame: At 12 weeks from the end of the intervention ]
    Change Perception with Global Rating of Change Scale (range -5 to + 5). - 5 means worst than before and +5 means Completely recovered



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   18 Years to 75 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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.


Publications:
Layout table for additonal information
Responsible Party: Raúl Ferrer-Peña, Professor and Researcher, Universidad Autonoma de Madrid
ClinicalTrials.gov Identifier: NCT04118439    
Other Study ID Numbers: 201936043
First Posted: October 8, 2019    Key Record Dates
Last Update Posted: October 9, 2019
Last Verified: October 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Layout table for additional information
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Raúl Ferrer-Peña, Universidad Autonoma de Madrid:
Motor Imaginery
Shoulder Pain
Chronic Pain
Prehabilitation
Additional relevant MeSH terms:
Layout table for MeSH terms
Shoulder Pain
Arthralgia
Joint Diseases
Musculoskeletal Diseases
Pain
Neurologic Manifestations
Signs and Symptoms