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

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

Overview

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

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Interventions

• Other 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

Primary outcome measures

• Pain Intensity [Time frame: Previous the intervention]
• Change in Pain Intensity [Time frame: At 30 days from the begining finishing the intervention]
• Change in Pain Intensity [Time frame: At the end of the usual care period of 4 weeks]
• Change in Pain Intensity [Time frame: Up to 12 weeks]

Secondary outcome measures (9)

• 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]

Eligibility criteria

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,

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.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation

Randomized

Model

Parallel assignment

Masking

Triple blind

Primary purpose

Treatment

Study locations

Center list to be confirmed — check the primary protocol.

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. PMID 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. PMID 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. PMID 27917103

Identifiers

NCT: NCT04118439 · PI-4001

Primary sources (government registries)

• ClinicalTrials.gov (US NIH)

View this study on ClinicalTrials.gov ↗