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Completed

NCT Number: NCT03086525

Influence of Beliefs on the Development of Musculoskeletal Pain.

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.

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Key information

Conditions

Musculoskeletal Pain Chronic Pain Muscular Diseases Musculoskeletal Diseases Neurologic Manifestations Pain Pathological Conditions, Signs and Symptoms Signs and Symptoms

Age range

18 year–80 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Univeristy of Malaga

Málaga, Spain

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Diagnosis/Prognosis

Other

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.

Primary outcomes

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

    Time frame: 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 outcomes

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

    Time frame: 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).

Other outcomes

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

    Time frame: 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

  2. Change from baseline the fear pain questionnaire (FPQ-III) at 12,24,36,48 months

    Time frame: 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

  3. Change from baseline the chronic pain acceptance questionnaire (CPAQ) at 12,24,36,48 months

    Time frame: 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

  4. Change from baseline the pain self-efficacy questionnaire (PSEQ) at 12,24,36,48 months

    Time frame: 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.

Sponsors and collaborators

Lead sponsor

University of Malaga

Other

Registry information

Official study 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

Important dates

Study start
2019
Primary completion
2020
Study completion
2020
First posted
Mar 22, 2017
Registry last updated
Aug 16, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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