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Influence of Beliefs on the Development of Musculoskeletal Pain.

9. august 2021 oppdatert av: 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.

Studieoversikt

Status

Fullført

Forhold

Intervensjon / Behandling

Detaljert beskrivelse

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

Observasjonsmessig

Registrering (Faktiske)

650

Kontakter og plasseringer

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Studiesteder

  • Spania
      • Malaga, Spania
        • Univeristy of Malaga

Deltakelseskriterier

Forskere ser etter personer som passer til en bestemt beskrivelse, kalt kvalifikasjonskriterier. Noen eksempler på disse kriteriene er en persons generelle helsetilstand eller tidligere behandlinger.

Kvalifikasjonskriterier

Alder som er kvalifisert for studier

18 år til 80 år (Voksen, Eldre voksen)

Tar imot friske frivillige

Ja

Kjønn som er kvalifisert for studier

Alle

Prøvetakingsmetode

Sannsynlighetsprøve

Studiepopulasjon

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

Beskrivelse

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.

Studieplan

Denne delen gir detaljer om studieplanen, inkludert hvordan studien er utformet og hva studien måler.

Hvordan er studiet utformet?

Designdetaljer

Kohorter og intervensjoner

Gruppe / Kohort
Intervensjon / Behandling
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.
Annen: 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.

Hva måler studien?

Primære resultatmål

Resultatmål
Tiltaksbeskrivelse
Tidsramme
Change from baseline the numerical pain rating scale (NRS) at 12,24,36,48 months
Tidsramme: 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).

Sekundære resultatmål

Resultatmål
Tiltaksbeskrivelse
Tidsramme
Change from baseline the pain disability questionnaire (PDQ) at 12,24,36,48 months
Tidsramme: 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)

Andre resultatmål

Resultatmål
Tiltaksbeskrivelse
Tidsramme
Change from baseline the tampa scale for kinsiophobia (TSK-11) at 12,24,36,48 months
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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)

Samarbeidspartnere og etterforskere

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Sponsor

University of Malaga

Studierekorddatoer

Disse datoene sporer fremdriften for innsending av studieposter og sammendragsresultater til ClinicalTrials.gov. Studieposter og rapporterte resultater gjennomgås av National Library of Medicine (NLM) for å sikre at de oppfyller spesifikke kvalitetskontrollstandarder før de legges ut på det offentlige nettstedet.

Studer hoveddatoer

Studiestart (Faktiske)

1. desember 2019

Primær fullføring (Faktiske)

1. januar 2020

Studiet fullført (Faktiske)

1. juni 2020

Datoer for studieregistrering

Først innsendt

16. mars 2017

Først innsendt som oppfylte QC-kriteriene

16. mars 2017

Først lagt ut (Faktiske)

22. mars 2017

Oppdateringer av studieposter

Sist oppdatering lagt ut (Faktiske)

16. august 2021

Siste oppdatering sendt inn som oppfylte QC-kriteriene

9. august 2021

Sist bekreftet

1. desember 2019

Mer informasjon

Begreper knyttet til denne studien

Nøkkelord

Ytterligere relevante MeSH-vilkår

Andre studie-ID-numre

  • UNOMalaga

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NEI

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Nei

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Nei

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