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.
Přehled studie
Detailní popis
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.
Typ studie
Zápis (Aktuální)
Kontakty a umístění
Studijní místa
-
-
-
Malaga, Španělsko
- Univeristy of Malaga
-
-
Kritéria účasti
Kritéria způsobilosti
Věk způsobilý ke studiu
Přijímá zdravé dobrovolníky
Pohlaví způsobilá ke studiu
Metoda odběru vzorků
Studijní populace
Popis
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.
Studijní plán
Jak je studie koncipována?
Detaily designu
Kohorty a intervence
Skupina / kohorta |
Intervence / Léčba |
|---|---|
|
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.
|
Co je měření studie?
Primární výstupní opatření
Měření výsledku |
Popis opatření |
Časové okno |
|---|---|---|
|
Change from baseline the numerical pain rating scale (NRS) at 12,24,36,48 months
Časové okno: 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).
|
Sekundární výstupní opatření
Měření výsledku |
Popis opatření |
Časové okno |
|---|---|---|
|
Change from baseline the pain disability questionnaire (PDQ) at 12,24,36,48 months
Časové okno: 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)
|
Další výstupní opatření
Měření výsledku |
Popis opatření |
Časové okno |
|---|---|---|
|
Change from baseline the tampa scale for kinsiophobia (TSK-11) at 12,24,36,48 months
Časové okno: 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
Časové okno: 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
Časové okno: 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
Časové okno: 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)
|
Spolupracovníci a vyšetřovatelé
Sponzor
Termíny studijních záznamů
Hlavní termíny studia
Začátek studia (Aktuální)
Primární dokončení (Aktuální)
Dokončení studie (Aktuální)
Termíny zápisu do studia
První předloženo
První předloženo, které splnilo kritéria kontroly kvality
První zveřejněno (Aktuální)
Aktualizace studijních záznamů
Poslední zveřejněná aktualizace (Aktuální)
Odeslaná poslední aktualizace, která splnila kritéria kontroly kvality
Naposledy ověřeno
Více informací
Termíny související s touto studií
Další relevantní podmínky MeSH
Další identifikační čísla studie
- UNOMalaga
Plán pro data jednotlivých účastníků (IPD)
Plánujete sdílet data jednotlivých účastníků (IPD)?
Informace o lécích a zařízeních, studijní dokumenty
Studuje lékový produkt regulovaný americkým FDA
Studuje produkt zařízení regulovaný americkým úřadem FDA
Tyto informace byly beze změn načteny přímo z webu clinicaltrials.gov. Máte-li jakékoli požadavky na změnu, odstranění nebo aktualizaci podrobností studie, kontaktujte prosím register@clinicaltrials.gov. Jakmile bude změna implementována na clinicaltrials.gov, bude automaticky aktualizována i na našem webu .