Clinical Trial

Effectiveness of Action Observation and Motor Imagery Intervention Plus Exercise for Chronic Painful Shoulder in Primary Care

Study acronym: OPTIMIST
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Summary
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.
Protocol Amendment History 3 amendments
This ClinicalTrials.gov record has been amended 3 times since 2019-10-04; most recent amendment 2025-03-17.
Trial Details
NCT Number NCT04118439
Lead Sponsor Universidad Autonoma de Madrid
Conditions Shoulder Pain
Enrollment 100 participants
Start Date 2025-06
Primary Completion 2026-12 (estimated)
Study Completion 2027-06 (estimated)
Updated on ClinicalTrials.gov 2025-03-20