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.
Aperçu de l'étude
Statut
Les conditions
Intervention / Traitement
Description détaillée
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.
Type d'étude
Inscription (Réel)
Contacts et emplacements
Lieux d'étude
-
-
-
Malaga, Espagne
- Univeristy of Malaga
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-
Critères de participation
Critère d'éligibilité
Âges éligibles pour étudier
Accepte les volontaires sains
Sexes éligibles pour l'étude
Méthode d'échantillonnage
Population étudiée
La description
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.
Plan d'étude
Comment l'étude est-elle conçue ?
Détails de conception
Cohortes et interventions
Groupe / Cohorte |
Intervention / Traitement |
|---|---|
|
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.
|
Que mesure l'étude ?
Principaux critères de jugement
Mesure des résultats |
Description de la mesure |
Délai |
|---|---|---|
|
Change from baseline the numerical pain rating scale (NRS) at 12,24,36,48 months
Délai: 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).
|
Mesures de résultats secondaires
Mesure des résultats |
Description de la mesure |
Délai |
|---|---|---|
|
Change from baseline the pain disability questionnaire (PDQ) at 12,24,36,48 months
Délai: 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)
|
Autres mesures de résultats
Mesure des résultats |
Description de la mesure |
Délai |
|---|---|---|
|
Change from baseline the tampa scale for kinsiophobia (TSK-11) at 12,24,36,48 months
Délai: 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
Délai: 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
Délai: 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
Délai: 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.
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Self-efficacy will be evaluated at baseline and 4 follow-ups (12,24,36,48 months)
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Collaborateurs et enquêteurs
Parrainer
Dates d'enregistrement des études
Dates principales de l'étude
Début de l'étude (Réel)
Achèvement primaire (Réel)
Achèvement de l'étude (Réel)
Dates d'inscription aux études
Première soumission
Première soumission répondant aux critères de contrôle qualité
Première publication (Réel)
Mises à jour des dossiers d'étude
Dernière mise à jour publiée (Réel)
Dernière mise à jour soumise répondant aux critères de contrôle qualité
Dernière vérification
Plus d'information
Termes liés à cette étude
Termes MeSH pertinents supplémentaires
Autres numéros d'identification d'étude
- UNOMalaga
Plan pour les données individuelles des participants (IPD)
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Informations sur les médicaments et les dispositifs, documents d'étude
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