Clinical trial NCT03086525: Influence of Beliefs on the Development of Musculoskeletal Pain.
Official title: 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
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Musculoskeletal Pain
Keywords: Chronic pain
Psychological factors
Musculoskeletal pain
Prognosis
Lead sponsor: University of Malaga
Sponsor class: OTHER
First posted: 2017-03-22
Enrollment: 650
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Subjects between 18-80 years without musculoskeletal pain, and students of the university of malaga

Brief summary: 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.

Detailed description: 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.

Eligibility criteria: 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.

Primary outcomes:
measure: Change from baseline the numerical pain rating scale (NRS) at 12,24,36,48 months
timeFrame: Pain will be evaluated at baseline and 4 follow-ups (12.24.36.48 months).
Secondary outcomes:
measure: Change from baseline the pain disability questionnaire (PDQ) at 12,24,36,48 months
timeFrame: Disability will be evaluated at baseline and 4 follow-ups (12,24,36,48 months)
Other outcomes:
measure: Change from baseline the tampa scale for kinsiophobia (TSK-11) at 12,24,36,48 months
timeFrame: Fear of movement will be evaluated at baseline and 4 follow-ups (12,24,36,48 months)
measure: Change from baseline the fear pain questionnaire (FPQ-III) at 12,24,36,48 months
timeFrame: Pain-related fear will be evaluated at baseline and 4 follow-ups (12,24,36,48 months)
measure: Change from baseline the chronic pain acceptance questionnaire (CPAQ) at 12,24,36,48 months
timeFrame: Pain acceptance will be evaluated at baseline and 4 follow-ups (12,24,36,48 months)
measure: Change from baseline the pain self-efficacy questionnaire (PSEQ) at 12,24,36,48 months
timeFrame: Self-efficacy will be evaluated at baseline and 4 follow-ups (12,24,36,48 months)
Locations:
city: Malaga
country: Spain
facility: Univeristy of Malaga
Study officials:
affiliation: University of Malaga
name: Alejandro Luque Suarez, PhD
role: PRINCIPAL_INVESTIGATOR
References: