Influence of Beliefs on the Development of Musculoskeletal Pain.

Study Overview
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Brief Summary
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Musculoskeletal pain is highly prevalent, disabling, and with high socio-economic costs, with many negative effects on quality of life. It affects the ability to perform work, social, recreational and domestic tasks, changing the mood and concentration of this population. Despite the worldwide prevalence and socioeconomic burden of this condition, a clear understanding of its etiology and pathogenesis remains elusive. Aims: (i) to analyze the possible level of association between fear of pain, fear of movement, self-efficacy, and pain acceptance on pain-disability at the start of the study and prospectively evaluate its role as a risk factor; (ii) to evaluate the possible role as a prognostic factor of fear of pain, fear of movement, self-efficacy and pain acceptance in those who develop musculoskeletal pain at follow-up; (iii) explore the possible mediating power of fear of movement and self-efficacy in the relationship between pain-disability; (iv) investigate what percentage of the variance accounts for beliefs (fear of pain, fear of movement, self-efficacy, and acceptance of pain) in predicting the onset and / or maintenance of musculoskeletal pain.

Detailed Description
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The present study will be a prospective observational study of 4 years that will be carried out between September 2017 and September 2020 at the University of Malaga. Several questionnaires assessing different beliefs associated with pain will be administered to participants. The results will be evaluated at baseline (t1) and in 4 follow-ups (at 12 (t2), 24 (t3), 36 (t4) and 48 (t5) months. It will be implemented and reported in line with the SPIRIT statement and the STROBE guidance. Participants A consecutive sample of healthy male and female students, students of the University of Málaga, will be recruited. Research assistants trained by the principal investigator will be in charge of carrying out the recruitment and evaluating the participants for their eligibility. Participants who meet the inclusion criteria will be invited to participate in this study, and then evaluated at baseline and at 12, 24, 36 and 48 months of follow-up. The inclusion criteria are as follows: (i) men / women over 18 years; (ii) students of the University of Málaga belonging to one of the disciplines previously mentioned. The exclusion criteria are as follows: (i) participants currently experiencing musculoskeletal pain; (ii) participants currently taking medication; (iii) previous histories of musculoskeletal surgery; (Iv) inability to provide written informed consent and / or complete questionnaires.

Official Title
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The Influence of Beliefs (Fear of Movement, Pain-related Fear, Self-efficacy, and Pain Acceptance) in the Development and/or Perpetuation of Muasculoskeletal Pain. Protocol

Conditions
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Musculoskeletal Pain

Intervention / Treatment
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* Other: Diagnosis/Prognosis


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: men / women over 18 years. students of the University of Málaga. Exclusion Criteria: participants currently experiencing musculoskeletal pain. participants currently taking medication. previous histories of musculoskeletal surgery. inability to provide written informed consent and / or complete questionnaires.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 80 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Musculoskeletal pain<br>Participants Healthy male and female students, students of the University of Málaga, will be recruited. . The inclusion criteria are as follows: (i) men / women over 18 years; (ii) students of the University of Málaga. | Other: Diagnosis/Prognosis<br>* The present study will be a prospective observational study of 4 years that will be carried out between September 2017 and September 2020 at the University of Malaga. Several questionnaires assessing different beliefs associated with pain will be administered to participants. The results will be evaluated at baseline (t1) and in 4 follow-ups (at 12 (t2), 24 (t3), 36 (t4) and 48 (t5) months.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change from baseline the numerical pain rating scale (NRS) at 12,24,36,48 months | Pain: The Numerical Rating Scale (NRS) will assess the pain intensity of each patient at baseline and prospectively. NRS scores range from 0 to 10, with 0 without pain and 10 with the worst pain imaginable. It has been shown that the NRS has a good test-retest reliability of the same day. | Pain will be evaluated at baseline and 4 follow-ups (12.24.36.48 months). | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change from baseline the pain disability questionnaire (PDQ) at 12,24,36,48 months | The Pain Disability Questionnaire (PDQ) is a 15-question questionnaire that evaluates musculoskeletal disorders focusing on disability and the ability of patients to perform activities of daily living. The marker ranges from 0 (optimal function) to 150 (total disability). | Disability will be evaluated at baseline and 4 follow-ups (12,24,36,48 months) | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Chronic pain, Psychological factors, Musculoskeletal pain, Prognosis