Influence of Beliefs on the Development of Musculoskeletal Pain.

Completed

• Conditions: Musculoskeletal Pain
• Interventions: Other: Diagnosis/Prognosis

• Registration Number: NCT03086525
• Lead Sponsor: 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.

Study Timeline

• Study First Submitted: 2017-03-16
• Study First Submitted QC: 2017-03-16
• Study First Posted: 2017-03-22
• Status Verified: 2019-12
• Study Start: 2019-12-01
• Primary Completion: 2020-01-01
• Study Completion: 2020-06-01
• Last Update Submitted: 2021-08-09
• Last Update Posted: 2021-08-16

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 650

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.

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Musculoskeletal pain	Diagnosis/Prognosis	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.

Primary Outcome Measures

Name	Time	Method
Change from baseline the numerical pain rating scale (NRS) at 12,24,36,48 months	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.

Secondary Outcome Measures

Name	Time	Method
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)	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).

Trial Locations

Locations (1)

Univeristy of Malaga; 🇪🇸 Malaga, Spain