Influence of Beliefs on the Development of Musculoskeletal Pain.

Musculoskeletal Pain Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03086525
• Other study ID #: UNOMalaga
• Status: Completed
• Start date: December 1, 2019
• Est. completion date: June 1, 2020

Study information

• Verified date: December 2019
• Source: University of Malaga
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 650
• Est. completion date: June 1, 2020
• Est. primary completion date: January 1, 2020
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 80 Years

Eligibility

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.

Related Conditions & MeSH terms

• Musculoskeletal Pain

Intervention

Other:
• 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.

Locations

Country	Name	City	State
Spain	Univeristy of Malaga	Malaga

Sponsors (1)

Lead Sponsor	Collaborator
University of Malaga

Country where clinical trial is conducted

Spain, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Change from baseline the tampa scale for kinsiophobia (TSK-11) at 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)
Other	Change from baseline the fear pain questionnaire (FPQ-III) at 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)
Other	Change from baseline the chronic pain acceptance questionnaire (CPAQ) at 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)
Other	Change from baseline the pain self-efficacy questionnaire (PSEQ) at 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)
Primary	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	Change from baseline the pain disability questionnaire (PDQ) at 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)