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NCT Number: NCT04118439

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

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.

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Key information

Age range

18 year–75 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

About this study

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 reducing disability, improving adherence to treatment and reducing the impact of pain on recovery. Although these techniques have been little explored in shoulder rehabilitation, they have scientific evidence in other areas of neuromusculoskeletal rehabilitation.

The study will be carried out in primary care, with the aim of improving the quality of the treatments available in these centers. The intervention will facilitate compliance with home treatment guidelines, which will shorten recovery times and sick leave, thus optimizing access to rehabilitation services for new patients.

A key component of the project will be the dissemination of results, both in the scientific community and in society. In addition to scientific publications and conference presentations, various dissemination strategies will be implemented: 1) Social networks social networks: Publication of summaries, graphics and explanatory videos about the project and its findings. 2) Teaching materials and practical guides : Development of resources aimed specifically at primary care physiotherapists to facilitate the implementation of the techniques in clinical practice. 3) Public awareness: Dissemination of information about chronic shoulder pain and advances in its treatment, through articles, press releases and interviews in specialized and general media.

This comprehensive approach will not only scientifically validate the intervention, but also transfer knowledge to health professionals and society, promoting a more accessible and effective treatment for patients with chronic shoulder pain

.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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,
  • 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.

Treatment and study plan

Motor Imaginery and Action Observation

Other

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 outcomes

  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 outcomes

  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

Sponsors and collaborators

Lead sponsor

Universidad Autonoma de Madrid

Other

Registry information

Official study 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

Acronym: OPTIMIST

Important dates

Study start
2025
Primary completion
2026
Study completion
2027
First posted
Oct 8, 2019
Registry last updated
Mar 20, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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