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Clinical Trial NCT04118439 (OPTIMIST) for Shoulder Pain is not yet recruiting. See the Trial Radar Card View and AI discovery tools for all the details. Or ask anything here. | ||
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Effectiveness of Action Observation and Motor Imagery Intervention Plus Exercise for Chronic Painful Shoulder in Primary Care (OPTIMIST) 100 Randomized Exercise-Based
Clinical Trial NCT04118439 (OPTIMIST) is an interventional study for Shoulder Pain and is currently not yet recruiting. Enrollment is planned to begin on June 1, 2025 and continue until the study accrues 100 participants. Led by Universidad Autonoma de Madrid, this study is expected to complete by June 1, 2027. The latest data from ClinicalTrials.gov was last updated on March 20, 2025.
Brief 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 chron...Show More
Detailed Description
The aim of this project is to investigate a new conservative therapeutic approach for patients with chronic shoulder pain, a highly prevalent condition in primary care, and with a significant percentage of patients experiencing persistent pain. The proposed intervention combines Action Observation (AO) and Motor Imagery (MI) techniques with the usual based on exercises, with the aim of enhancing its effects by reduci...Show More
Official Title
Effectiveness of an Exercise Program Combined With Action Observation and Motor Imagery in Patients With Chronic Shoulder Pain in Primary Care. A Controlled Clinical Trial
Conditions
Shoulder PainPublications
Scientific articles and research papers published about this clinical trial:Other Study IDs
- OPTIMIST
- PI-4001
NCT ID Number
Start Date (Actual)
2025-06
Last Update Posted
2025-03-20
Completion Date (Estimated)
2027-06
Enrollment (Estimated)
100
Study Type
Interventional
PHASE
N/A
Status
Not yet recruiting
Keywords
Motor Imaginery
Shoulder Pain
Chronic Pain
Shoulder Pain
Chronic Pain
Primary Purpose
Treatment
Design Allocation
Randomized
Interventional Model
Parallel
Masking
Triple
Arms / Interventions
| Participant Group/Arm | Intervention/Treatment |
|---|---|
ExperimentalMotor 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 | 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 InterventionControl 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. | N/A |
Primary Outcome Measures
Secondary Outcome Measures
| Outcome Measure | Measure Description | Time Frame |
|---|---|---|
Pain Intensity | Pain Intensity with Visual Analogue Scale (range: 0-10). Higher scores mean more intensity | Previous the intervention |
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 |
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 |
Change in Pain Intensity | Pain Intensity with Visual Analogue Scale (range: 0-10). Higher scores mean more intensity | Up to 12 weeks |
| Outcome Measure | Measure Description | Time Frame |
|---|---|---|
Shoulder Disability: SPADI questionnaire | Shoulder Disability with SPADI questionnaire (range: 0-100). Higher scores mean more disability | Previous the intervention |
Change in Shoulder Disability | Shoulder Disability with SPADI questionnaire (range: 0-100). Higher scores mean more disability | Up to 12 weeks |
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 |
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 |
Pain Catastrophizing | Pain Catastrophizing with Pain Catastrophizing Scale (range 0-52). Higher scores mean more catastrophizing | Previous the intervention |
Change in Pain Catastrophizing | Pain Catastrophizing with Pain Catastrophizing Scale (range 0-52). Higher scores mean more Catastrophizing | Up to 12 weeks |
Pain Severity | Pain Severity with Graded Chonic Pain Scale (rango 0-70). Higher scores mean more severity | Previous the intervention |
Change in Pain Severity | Pain Severity with Graded Chonic Pain Scale (rango 0-70). Higher scores mean more severity | Up to 12 weeks |
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 |
Participation Assistant
Eligibility Criteria
Eligible Ages
Adult, Older Adult
Minimum Age
18 Years
Eligible Sexes
All
- 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.
- 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.
Universidad Autonoma de MadridStudy Responsible Party
Raúl Ferrer-Peña, Principal Investigator, Professor and Researcher, Universidad Autonoma de Madrid
No contact data.