Shoulder PainOPTIMISTNCT04118439
Effectiveness of Action Observation and Motor Imagery Intervention Plus Exercise for Chronic Painful Shoulder in Primary Care
A study testing Motor Imaginery and Action Observation in people with Shoulder Pain, run by Universidad Autonoma de Madrid.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Shoulder Pain
- What is being tested?
- Motor Imaginery and Action Observation
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 100 participants
- Where
- No sites listed yet
- Study dates
- Jun 2025to Jun 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
About this study
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
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.
Read the 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 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
.
- Conditions
- Shoulder Pain
- Being tested
- Motor Imaginery and Action Observation
- Keywords
- Motor Imaginery, Shoulder Pain, Chronic Pain
- Medical subject headings
- Shoulder Pain, Chronic Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Motor Imaginery and Action ObservationOther
A set of tasks done with the shoulder, first with an Action Observation perspective and then asked to perform this tasks with motor imaginery
| Study group | Role | What they receive |
|---|---|---|
| Motor Imaginery | Experimental | 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 Receives: Other: Motor Imaginery and Action Observation |
| Control Group | No intervention | 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. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Pain Intensity
Pain Intensity with Visual Analogue Scale (range: 0-10). Higher scores mean more intensity
Measured: Previous the intervention
Change in Pain Intensity
Pain Intensity with Visual Analogue Scale (range: 0-10). Higher scores mean more intensity
Measured: 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
Measured: 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
Measured: Up to 12 weeks
Secondary outcomes (9)
Shoulder Disability: SPADI questionnaire
Shoulder Disability with SPADI questionnaire (range: 0-100). Higher scores mean more disability
Measured: Previous the intervention
Change in Shoulder Disability
Shoulder Disability with SPADI questionnaire (range: 0-100). Higher scores mean more disability
Measured: 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
Measured: 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
Measured: Up to 12 weeks
Pain Catastrophizing
Pain Catastrophizing with Pain Catastrophizing Scale (range 0-52). Higher scores mean more catastrophizing
Measured: Previous the intervention
Change in Pain Catastrophizing
Pain Catastrophizing with Pain Catastrophizing Scale (range 0-52). Higher scores mean more Catastrophizing
Measured: Up to 12 weeks
Pain Severity
Pain Severity with Graded Chonic Pain Scale (rango 0-70). Higher scores mean more severity
Measured: Previous the intervention
Change in Pain Severity
Pain Severity with Graded Chonic Pain Scale (rango 0-70). Higher scores mean more severity
Measured: 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
Measured: At 12 weeks from the end of the intervention
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Oct 2019
- Study startJun 2025 (estimated)
- Primary completionDec 2026 (estimated)
- Study completionJun 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Shoulder PainStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Randomized Clinical Trial
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Outcomes assessor
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Universidad Autonoma de Madrid
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Raúl Ferrer-Peña, Universidad Autonoma de Madrid
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04118439
- Sponsor's protocol ID
- PI-4001
- Acronym
- OPTIMIST
- Status last verified
- Mar 2025
- First submitted
- 3 Oct 2019
- Last updated
- 20 Mar 2025
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Luime JJ, Koes BW, Hendriksen IJ, Burdorf A, Verhagen AP, Miedema HS, Verhaar JA. Prevalence and incidence of shoulder pain in the general population; a systematic review. Scand J Rheumatol. 2004;33(2):73-81. doi: 10.1080/03009740310004667.
PubMed 15163107Tinazzi M, Fiaschi A, Rosso T, Faccioli F, Grosslercher J, Aglioti SM. Neuroplastic changes related to pain occur at multiple levels of the human somatosensory system: A somatosensory-evoked potentials study in patients with cervical radicular pain. J Neurosci. 2000 Dec 15;20(24):9277-83. doi: 10.1523/JNEUROSCI.20-24-09277.2000.
PubMed 11125006Eaves DL, Riach M, Holmes PS, Wright DJ. Motor Imagery during Action Observation: A Brief Review of Evidence, Theory and Future Research Opportunities. Front Neurosci. 2016 Nov 21;10:514. doi: 10.3389/fnins.2016.00514. eCollection 2016.
PubMed 27917103
Study at a glance
From the registry record, last updated by the sponsor on 20 Mar 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT04118439
- Acronym / sponsor ID
- OPTIMIST / PI-4001
- Conditions
- Shoulder Pain
- Keywords
- Motor Imaginery, Shoulder Pain, Chronic Pain
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- Universidad Autonoma de MadridUniversity, hospital or other
- Study start
- Jun 2025 (estimated)
- Primary completion
- Dec 2026 (estimated)
- Study completion
- Jun 2027 (estimated)
- First posted
- 8 Oct 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 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
.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, outcomes assessor)
- Number of arms
- 2
- Model description
- Randomized Clinical Trial
| Arm | Type | Receives |
|---|---|---|
| Motor Imaginery | Experimental | Other: Motor Imaginery and Action ObservationPatients 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 |
| Control Group | No intervention | –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. |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- 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.
Key exclusion criteria (5 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Motor Imaginery and Action ObservationA set of tasks done with the shoulder, first with an Action Observation perspective and then asked to perform this tasks with motor imaginery | Other | Motor Imaginery |
Primary outcome
Pain Intensity
Time frame: Previous the intervention
Pain Intensity with Visual Analogue Scale (range: 0-10). Higher scores mean more intensity
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
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
Change in Pain Intensity
Time frame: Up to 12 weeks
Pain Intensity with Visual Analogue Scale (range: 0-10). Higher scores mean more intensity
9 secondary outcomes
Shoulder Disability: SPADI questionnaire
Time frame: Previous the intervention
Change in Shoulder Disability
Time frame: Up to 12 weeks
Health Related Quality of Live
Time frame: Previous the intervention
Change in Health Related Quality of Live
Time frame: Up to 12 weeks
Pain Catastrophizing
Time frame: Previous the intervention
Change in Pain Catastrophizing
Time frame: Up to 12 weeks
Pain Severity
Time frame: Previous the intervention
Change in Pain Severity
Time frame: Up to 12 weeks
Change Perception
Time frame: At 12 weeks from the end of the intervention
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Mar 2025.
- Background: PubMed 15163107Luime JJ, Koes BW, Hendriksen IJ, Burdorf A, Verhagen AP, Miedema HS, Verhaar JA. Prevalence and incidence of shoulder pain in the general population; a systematic review. Scand J Rheumatol. 2004;33(2):73-81. doi: 10.1080/03009740310004667.
- Background: PubMed 11125006Tinazzi M, Fiaschi A, Rosso T, Faccioli F, Grosslercher J, Aglioti SM. Neuroplastic changes related to pain occur at multiple levels of the human somatosensory system: A somatosensory-evoked potentials study in patients with cervical radicular pain. J Neurosci. 2000 Dec 15;20(24):9277-83. doi: 10.1523/JNEUROSCI.20-24-09277.2000.
- Background: PubMed 27917103Eaves DL, Riach M, Holmes PS, Wright DJ. Motor Imagery during Action Observation: A Brief Review of Evidence, Theory and Future Research Opportunities. Front Neurosci. 2016 Nov 21;10:514. doi: 10.3389/fnins.2016.00514. eCollection 2016.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
A study testing Motor Imaginery and Action Observation in people with Shoulder Pain, run by Universidad Autonoma de Madrid.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 20 Mar 2025. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Pain Intensity (time frame: Previous the intervention). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04118439, which also lists 3 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 20 Mar 2025.