Clinical trial NCT04118439: 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
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: Shoulder Pain
Keywords: Motor Imaginery
Shoulder Pain
Chronic Pain
Lead sponsor: Universidad Autonoma de Madrid
Sponsor class: OTHER
First posted: 2019-10-08
Enrollment: 100
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Randomized Clinical Trial
Primary purpose: TREATMENT

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.

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

.

Eligibility criteria: 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:

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,

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.

Primary outcomes:
measure: Pain Intensity
timeFrame: Previous the intervention
measure: Change in Pain Intensity
timeFrame: At 30 days from the begining finishing the intervention
measure: Change in Pain Intensity
timeFrame: At the end of the usual care period of 4 weeks
measure: Change in Pain Intensity
timeFrame: Up to 12 weeks
Secondary outcomes:
measure: Shoulder Disability: SPADI questionnaire
timeFrame: Previous the intervention
measure: Change in Shoulder Disability
timeFrame: Up to 12 weeks
measure: Health Related Quality of Live
timeFrame: Previous the intervention
measure: Change in Health Related Quality of Live
timeFrame: Up to 12 weeks
measure: Pain Catastrophizing
timeFrame: Previous the intervention
measure: Change in Pain Catastrophizing
timeFrame: Up to 12 weeks
measure: Pain Severity
timeFrame: Previous the intervention
measure: Change in Pain Severity
timeFrame: Up to 12 weeks
measure: Change Perception
timeFrame: At 12 weeks from the end of the intervention
Other outcomes:
Locations:
Study officials:
References:
citation: 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.
citation: 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.
citation: 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.