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Influence of Beliefs on the Development of Musculoskeletal Pain.

9 augustus 2021 bijgewerkt door: Alejandro Luque-Suarez, University of Malaga

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.

Studie Overzicht

Toestand

Voltooid

Conditie

Interventie / Behandeling

Gedetailleerde beschrijving

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.

Studietype

Observationeel

Inschrijving (Werkelijk)

650

Contacten en locaties

In dit gedeelte vindt u de contactgegevens van degenen die het onderzoek uitvoeren en informatie over waar dit onderzoek wordt uitgevoerd.

Studie Locaties

  • Spanje
      • Malaga, Spanje
        • Univeristy of Malaga

Deelname Criteria

Onderzoekers zoeken naar mensen die aan een bepaalde beschrijving voldoen, de zogenaamde geschiktheidscriteria. Enkele voorbeelden van deze criteria zijn iemands algemene gezondheidstoestand of eerdere behandelingen.

Geschiktheidscriteria

Leeftijden die in aanmerking komen voor studie

18 jaar tot 80 jaar (Volwassen, Oudere volwassene)

Accepteert gezonde vrijwilligers

Ja

Geslachten die in aanmerking komen voor studie

Allemaal

Bemonsteringsmethode

Kanssteekproef

Studie Bevolking

Subjects between 18-80 years without musculoskeletal pain, and students of the university of malaga

Beschrijving

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.

Studie plan

Dit gedeelte bevat details van het studieplan, inclusief hoe de studie is opgezet en wat de studie meet.

Hoe is de studie opgezet?

Ontwerpdetails

Cohorten en interventies

Groep / Cohort
Interventie / Behandeling
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.
Ander: Diagnosis/Prognosis
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.

Wat meet het onderzoek?

Primaire uitkomstmaten

Uitkomstmaat
Maatregel Beschrijving
Tijdsspanne
Change from baseline the numerical pain rating scale (NRS) at 12,24,36,48 months
Tijdsspanne: 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).

Secundaire uitkomstmaten

Uitkomstmaat
Maatregel Beschrijving
Tijdsspanne
Change from baseline the pain disability questionnaire (PDQ) at 12,24,36,48 months
Tijdsspanne: 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)

Andere uitkomstmaten

Uitkomstmaat
Maatregel Beschrijving
Tijdsspanne
Change from baseline the tampa scale for kinsiophobia (TSK-11) at 12,24,36,48 months
Tijdsspanne: 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
Tijdsspanne: 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
Tijdsspanne: 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
Tijdsspanne: 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)

Medewerkers en onderzoekers

Hier vindt u mensen en organisaties die betrokken zijn bij dit onderzoek.

Sponsor

University of Malaga

Studie record data

Deze datums volgen de voortgang van het onderzoeksdossier en de samenvatting van de ingediende resultaten bij ClinicalTrials.gov. Studieverslagen en gerapporteerde resultaten worden beoordeeld door de National Library of Medicine (NLM) om er zeker van te zijn dat ze voldoen aan specifieke kwaliteitscontrolenormen voordat ze op de openbare website worden geplaatst.

Bestudeer belangrijke data

Studie start (Werkelijk)

1 december 2019

Primaire voltooiing (Werkelijk)

1 januari 2020

Studie voltooiing (Werkelijk)

1 juni 2020

Studieregistratiedata

Eerst ingediend

16 maart 2017

Eerst ingediend dat voldeed aan de QC-criteria

16 maart 2017

Eerst geplaatst (Werkelijk)

22 maart 2017

Updates van studierecords

Laatste update geplaatst (Werkelijk)

16 augustus 2021

Laatste update ingediend die voldeed aan QC-criteria

9 augustus 2021

Laatst geverifieerd

1 december 2019

Meer informatie

Termen gerelateerd aan deze studie

Trefwoorden

Aanvullende relevante MeSH-voorwaarden

Andere studie-ID-nummers

  • UNOMalaga

Plan Individuele Deelnemersgegevens (IPD)

Bent u van plan om gegevens van individuele deelnemers (IPD) te delen?

NEE

Informatie over medicijnen en apparaten, studiedocumenten

Bestudeert een door de Amerikaanse FDA gereguleerd geneesmiddel

Nee

Bestudeert een door de Amerikaanse FDA gereguleerd apparaatproduct

Nee

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