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

NCT04118439 | Not Yet Recruiting

• 1 other identifier: PI-4001
• Study Type: interventional
• Target: 100
• Locations: 0 countries
• Sites: N/A

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 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.

Conditions

Shoulder Pain

Keywords

Motor Imaginery; Shoulder Pain; Chronic Pain

Outcome Measures

Primary Outcomes (4)

• 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

Secondary Outcomes (9)

• Shoulder Disability: SPADI questionnaire

  Previous the intervention

• Change in Shoulder Disability

  Up to 12 weeks

• Health Related Quality of Live

  Previous the intervention

• Change in Health Related Quality of Live

  Up to 12 weeks

• Pain Catastrophizing

  Previous the intervention

Study Arms (2)

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

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.

Interventions

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

Motor Imaginery

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Universidad Autonoma de Madrid: lead

Related Publications (3)

• 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.

  PMID: 15163107 BACKGROUND

• 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.

  PMID: 11125006 BACKGROUND

• 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.

  PMID: 27917103 BACKGROUND

MeSH Terms

Conditions

Shoulder Pain; Chronic Pain

Condition Hierarchy (Ancestors)

Arthralgia; Joint Diseases; Musculoskeletal Diseases; Pain; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor and Researcher

Model Details: Randomized Clinical Trial

Study Record Dates

• First Submitted: October 3, 2019
• First Posted: October 8, 2019
• Study Start: June 1, 2025
• Primary Completion (Estimated): December 1, 2026
• Study Completion (Estimated): June 1, 2027
• Last Updated: March 20, 2025

Record last verified: 2025-03

Data Sharing

• IPD Sharing: Will not share