NCT03086525

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
650

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Dec 2019

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

March 16, 2017

Completed
6 days until next milestone

First Posted

Study publicly available on registry

March 22, 2017

Completed
2.7 years until next milestone

Study Start

First participant enrolled

December 1, 2019

Completed
1 month until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2020

Completed
5 months until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2020

Completed
Last Updated

August 16, 2021

Status Verified

December 1, 2019

Enrollment Period

1 month

First QC Date

March 16, 2017

Last Update Submit

August 9, 2021

Conditions

Musculoskeletal Pain

Keywords

Chronic painPsychological factorsMusculoskeletal painPrognosis

Outcome Measures

Primary Outcomes (1)

  • Change from baseline the numerical pain rating scale (NRS) at 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).

Secondary Outcomes (1)

  • Change from baseline the pain disability questionnaire (PDQ) at 12,24,36,48 months

    Disability will be evaluated at baseline and 4 follow-ups (12,24,36,48 months)

Other Outcomes (4)

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

    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

    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

    Pain acceptance will be evaluated at baseline and 4 follow-ups (12,24,36,48 months)

  • +1 more other outcomes

Study Arms (1)

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.

Other: Diagnosis/Prognosis

Interventions

Diagnosis/PrognosisOTHER

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.

Musculoskeletal pain

Eligibility Criteria

Age18 Years - 80 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
Study Population

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

You may qualify if:

  • men / women over 18 years.
  • students of the University of Málaga.

You may not qualify if:

  • participants currently experiencing musculoskeletal pain.
  • participants currently taking medication.
  • previous histories of musculoskeletal surgery.
  • inability to provide written informed consent and / or complete questionnaires.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Univeristy of Malaga

Málaga, Spain

Location

MeSH Terms

Conditions

Musculoskeletal PainChronic Pain

Condition Hierarchy (Ancestors)

Muscular DiseasesMusculoskeletal DiseasesPainNeurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and Symptoms

Study Officials

  • Alejandro Luque Suarez, PhD

    University of Malaga

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
PhD

Study Record Dates

First Submitted

March 16, 2017

First Posted

March 22, 2017

Study Start

December 1, 2019

Primary Completion

January 1, 2020

Study Completion

June 1, 2020

Last Updated

August 16, 2021

Record last verified: 2019-12

Data Sharing

IPD Sharing
Will not share

Locations

ES(1)