ClinicalTrials.gg
Not yet recruitingNCT04118439OPTIMISTUpdated Mar 20, 2025

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

An interventional study of Motor Imaginery and Action Observation in Shoulder Pain, sponsored by Universidad Autonoma de Madrid. Not yet recruiting. Open to participants aged 18 Years to 75 Years. Per ClinicalTrials.gov, last updated 2025-03-20.

Sponsored by Universidad Autonoma de Madrid · Not applicable, Interventional, and Treatment

Phase
Not applicable
Study type
Interventional
Enrollment
100
Allocation
Randomized
Ages
18 Years to 75 Years
Sex
All
01

Study 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.

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

.

02

Conditions studied

  • Shoulder Pain

Keywords

  • Motor Imaginery
  • Shoulder Pain
  • Chronic Pain
03

In context

Shoulder Pain

735 studies on the registry are indexed under Shoulder Pain; 167 are open to participants now.

This study's planned enrollment of 100 is above the median of 60 across 587 interventional studies indexed under Shoulder Pain.

Browse Shoulder Pain studies →

Lead sponsor

Universidad Autonoma de Madrid is the lead sponsor of 51 studies on the registry; 7 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 75 Years
Sexes eligible
All
Accepts healthy volunteers
No

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

  1. 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,
  2. who have not received physiotherapy treatment by the same process in the last 6 months.

Exclusion criteria

Exclusion Criteria:

  1. suffer from systemic diseases such as rheumatoid arthritis, fibromyalgia, diagnosed neurological disease, lupus erythematosus, or cancer.
  2. History of shoulder surgery,
  3. patients with psychiatric pathologies or personality disorders;
  4. patients with severe mobility limitation compatible with the diagnosis of frozen shoulder, 5) patients diagnosed with type II diabetes,
  1. 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.
05

Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Triple (Participant, Care provider, Outcomes assessor)
Enrollment
100 participants (estimated)

Study arms

  • Experimental
    Motor 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

    Other: Motor Imaginery and Action Observation

  • No intervention
    Control 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.

Interventions

  • OtherMotor 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

06

What researchers measure

Primary outcomes

  1. Pain Intensity

    Pain Intensity with Visual Analogue Scale (range: 0-10). Higher scores mean more intensity

    Time frame: Previous the intervention

  2. Change in Pain Intensity

    Pain Intensity with Visual Analogue Scale (range: 0-10). Higher scores mean more intensity

    Time frame: At 30 days from the begining finishing the intervention

  3. Change in Pain Intensity

    Pain Intensity with Visual Analogue Scale (range: 0-10). Higher scores mean more intensity

    Time frame: At the end of the usual care period of 4 weeks

  4. Change in Pain Intensity

    Pain Intensity with Visual Analogue Scale (range: 0-10). Higher scores mean more intensity

    Time frame: Up to 12 weeks

Secondary outcomes

  1. Shoulder Disability: SPADI questionnaire

    Shoulder Disability with SPADI questionnaire (range: 0-100). Higher scores mean more disability

    Time frame: Previous the intervention

  2. Change in Shoulder Disability

    Shoulder Disability with SPADI questionnaire (range: 0-100). Higher scores mean more disability

    Time frame: Up to 12 weeks

  3. Health Related Quality of Live

    Health Related Quality of Live with EuroQoL-5D-5L (range 11111 - 55555). Higher scores mean worst Quality of Life

    Time frame: Previous the intervention

  4. 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

    Time frame: Up to 12 weeks

  5. Pain Catastrophizing

    Pain Catastrophizing with Pain Catastrophizing Scale (range 0-52). Higher scores mean more catastrophizing

    Time frame: Previous the intervention

  6. Change in Pain Catastrophizing

    Pain Catastrophizing with Pain Catastrophizing Scale (range 0-52). Higher scores mean more Catastrophizing

    Time frame: Up to 12 weeks

  7. Pain Severity

    Pain Severity with Graded Chonic Pain Scale (rango 0-70). Higher scores mean more severity

    Time frame: Previous the intervention

  8. Change in Pain Severity

    Pain Severity with Graded Chonic Pain Scale (rango 0-70). Higher scores mean more severity

    Time frame: Up to 12 weeks

  9. Change Perception

    Change Perception with Global Rating of Change Scale (range -5 to + 5). - 5 means worst than before and +5 means Completely recovered

    Time frame: At 12 weeks from the end of the intervention

07

Study locations

No study locations are listed for this record.

08

References and documents

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 15163107 ↗
  • Tinazzi 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 11125006 ↗
  • Eaves 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 ↗

Individual participant data

Plan to share: No

09

Timeline

Tracking since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reachedSimilar studies: half by the dot; the band is the middle halfHalf of similar studies reached it by the dot; the band is the middle half, from a quarter to three quarters

Start is estimated for Jun 2025; primary completion for Dec 2026, 18 months later.

Of 349 non-industry interventional studies with no phase under Shoulder Pain, half reached primary completion within 11 months of starting (the median), counting those still running; a quarter within 4 and three quarters within 27. This study's planned 18 months is above that.

Counting every sponsor, half of 354 studies reached it within 11 months; a quarter within 4 and three quarters within 27.

How these figures are worked out, and which studies are left out of them.

Registered
Oct 3, 2019
First posted
Oct 8, 2019
StartEst.
Jun 2025
Primary completionEst.
Dec 2026
CompletionEst.
Jun 2027
Last update
Mar 20, 2025
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Mar 20, 2025, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT04118439
Lead sponsor
Universidad Autonoma de Madrid
Responsible party
Raúl Ferrer-Peña (Professor and Researcher, Universidad Autonoma de Madrid) — Principal investigator
First posted
Oct 8, 2019
Start date
Jun 2025 (estimated)
Primary completion
Dec 2026 (estimated)
Completion
Jun 2027 (estimated)
Last update
Mar 20, 2025

Oversight

FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is not yet recruiting, as verified in Mar 2025. You cannot join it, but the record below documents what was studied.

Follow this study

Get an email when the registry record changes — status, dates, results — or when someone posts here.

Sign in to follow

Discussion

Questions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.

Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.

Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.

Start the discussion