Influence of Beliefs on the Development of Musculoskeletal Pain.
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
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.
研究概览
详细说明
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.
研究类型
注册 (实际的)
联系人和位置
学习地点
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Malaga、西班牙
- Univeristy of Malaga
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参与标准
资格标准
适合学习的年龄
接受健康志愿者
有资格学习的性别
取样方法
研究人群
描述
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.
学习计划
研究是如何设计的？
设计细节
队列和干预
团体/队列 |
干预/治疗 |
|---|---|
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Musculoskeletal pain
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.
|
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.
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研究衡量的是什么？
主要结果指标
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
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Change from baseline the numerical pain rating scale (NRS) at 12,24,36,48 months
大体时间：Pain will be evaluated at baseline and 4 follow-ups (12.24.36.48 months).
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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.
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Pain will be evaluated at baseline and 4 follow-ups (12.24.36.48 months).
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次要结果测量
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
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Change from baseline the pain disability questionnaire (PDQ) at 12,24,36,48 months
大体时间：Disability will be evaluated at baseline and 4 follow-ups (12,24,36,48 months)
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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).
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Disability will be evaluated at baseline and 4 follow-ups (12,24,36,48 months)
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其他结果措施
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
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Change from baseline the tampa scale for kinsiophobia (TSK-11) at 12,24,36,48 months
大体时间：Fear of movement will be evaluated at baseline and 4 follow-ups (12,24,36,48 months)
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Fear of movement: The short version of the Tampa Scale for Kinesiophobia (TSK-11) will be used to assess fear of movement
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Fear of movement will be evaluated at baseline and 4 follow-ups (12,24,36,48 months)
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Change from baseline the fear pain questionnaire (FPQ-III) at 12,24,36,48 months
大体时间：Pain-related fear will be evaluated at baseline and 4 follow-ups (12,24,36,48 months)
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Pain-related fear: The short version (9-items) of the Fear of Pain Questionnaire (FPQ-III) will be used to assess the fear of pain in this population
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Pain-related fear will be evaluated at baseline and 4 follow-ups (12,24,36,48 months)
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Change from baseline the chronic pain acceptance questionnaire (CPAQ) at 12,24,36,48 months
大体时间：Pain acceptance will be evaluated at baseline and 4 follow-ups (12,24,36,48 months)
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Pain acceptance: The Chronic Pain Acceptance Questionnaire (CPAQ) will measure pain acceptance through 20 items
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Pain acceptance will be evaluated at baseline and 4 follow-ups (12,24,36,48 months)
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Change from baseline the pain self-efficacy questionnaire (PSEQ) at 12,24,36,48 months
大体时间：Self-efficacy will be evaluated at baseline and 4 follow-ups (12,24,36,48 months)
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Self-efficacy: The Pain Self-Efficacy Questionnaire (PSEQ) contains 10 questions that will measure the patient's confidence in performing certain activities despite pain.
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Self-efficacy will be evaluated at baseline and 4 follow-ups (12,24,36,48 months)
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合作者和调查者
研究记录日期
研究主要日期
学习开始 (实际的)
初级完成 (实际的)
研究完成 (实际的)
研究注册日期
首次提交
首先提交符合 QC 标准的
首次发布 (实际的)
研究记录更新
最后更新发布 (实际的)
上次提交的符合 QC 标准的更新
最后验证
更多信息
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