About this trial
Objective: to evaluate the effectiveness of an action observation program (OA) and motor imagery (MI) -integrated into routine physiotherapy practice- to reduce disability associated with chronic shoulder pain in primary care, after 8 weeks of intervention and with follow-ups at 3 and 6 months with blind evaluation of the response variable. Design: randomized controlled clinical trial. Population: Patients with chronic shoulder pain diagnosed and referred by their family doctors to the physiotherapy service will be included. Intervention: Group: experimental: MI+OA+ multicomponent exercises or control group: multicomponent exercises. 100 patients (50 per group) will be included. Variables: sociodemographic and clinical variables will be collected.
Primary variable: Disability related to pain in the shoulder region; Secondary variables: Intensity of perceived pain, Shoulder Joint Range of Motion, Hand and shoulder strength, Fear of movement, Catastrophizing in the face of pain, Quality of life of patients, Global Perception of Change, and adherence to exercise. Statistical analysis: Descriptive. Main effectiveness analysis by intention to treat comparing the difference between groups in the average disability for the different intervention times.
Multivariate analysis considers the influence of psychological variables on pain and on the therapeutic response. An analysis segmented by sex will be carried out, and the influence of psychological variables on pain and on the therapeutic response will be analyzed.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
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.
Disqualifiers
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,
Trial design
Parallel
Treatments tested in this trial
Motor Imaginery and Action Observation
Other interventionA set of tasks done with the shoulder, first with an Action Observation perspective and then asked to perform this tasks with motor imaginery
Treatment groups
Trial outcomes
Primary outcomes
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 outcomes
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
Locations
Sponsors and contacts
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