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.
調査の概要
詳細な説明
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.
研究の種類
入学 (実際)
連絡先と場所
研究場所
-
-
-
Malaga、スペイン
- Univeristy of Malaga
-
-
参加基準
適格基準
就学可能な年齢
健康ボランティアの受け入れ
受講資格のある性別
サンプリング方法
調査対象母集団
説明
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.
研究計画
研究はどのように設計されていますか？
デザインの詳細
コホートと介入
グループ/コホート |
介入・治療 |
|---|---|
|
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.
|
この研究は何を測定していますか？
主要な結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
|
Change from baseline the numerical pain rating scale (NRS) at 12,24,36,48 months
時間枠：Pain will be evaluated at baseline and 4 follow-ups (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).
|
二次結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
|
Change from baseline the pain disability questionnaire (PDQ) at 12,24,36,48 months
時間枠：Disability will be evaluated at baseline and 4 follow-ups (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)
|
その他の成果指標
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
|
Change from baseline the tampa scale for kinsiophobia (TSK-11) at 12,24,36,48 months
時間枠：Fear of movement will be evaluated at baseline and 4 follow-ups (12,24,36,48 months)
|
Fear of movement: The short version of the Tampa Scale for Kinesiophobia (TSK-11) will be used to assess fear of movement
|
Fear of movement will be evaluated at baseline and 4 follow-ups (12,24,36,48 months)
|
|
Change from baseline the fear pain questionnaire (FPQ-III) at 12,24,36,48 months
時間枠：Pain-related fear will be evaluated at baseline and 4 follow-ups (12,24,36,48 months)
|
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
|
Pain-related fear will be evaluated at baseline and 4 follow-ups (12,24,36,48 months)
|
|
Change from baseline the chronic pain acceptance questionnaire (CPAQ) at 12,24,36,48 months
時間枠：Pain acceptance will be evaluated at baseline and 4 follow-ups (12,24,36,48 months)
|
Pain acceptance: The Chronic Pain Acceptance Questionnaire (CPAQ) will measure pain acceptance through 20 items
|
Pain acceptance will be evaluated at baseline and 4 follow-ups (12,24,36,48 months)
|
|
Change from baseline the pain self-efficacy questionnaire (PSEQ) at 12,24,36,48 months
時間枠：Self-efficacy will be evaluated at baseline and 4 follow-ups (12,24,36,48 months)
|
Self-efficacy: The Pain Self-Efficacy Questionnaire (PSEQ) contains 10 questions that will measure the patient's confidence in performing certain activities despite pain.
|
Self-efficacy will be evaluated at baseline and 4 follow-ups (12,24,36,48 months)
|
協力者と研究者
スポンサー
研究記録日
主要日程の研究
研究開始 (実際)
一次修了 (実際)
研究の完了 (実際)
試験登録日
最初に提出
QC基準を満たした最初の提出物
最初の投稿 (実際)
学習記録の更新
投稿された最後の更新 (実際)
QC基準を満たした最後の更新が送信されました
最終確認日
詳しくは
この情報は、Web サイト clinicaltrials.gov から変更なしで直接取得したものです。研究の詳細を変更、削除、または更新するリクエストがある場合は、register@clinicaltrials.gov。 までご連絡ください。 clinicaltrials.gov に変更が加えられるとすぐに、ウェブサイトでも自動的に更新されます。
筋骨格痛の臨床試験
-
Dexa Medica Group完了