Influence of Beliefs on the Development of Musculoskeletal Pain.
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
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.
연구 개요
상세 설명
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.
연구 유형
등록 (실제)
연락처 및 위치
연구 장소
-
-
-
Malaga, 스페인
- Univeristy of Malaga
-
-
참여기준
자격 기준
공부할 수 있는 나이
건강한 자원 봉사자를 받아들입니다
연구 대상 성별
샘플링 방법
연구 인구
설명
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.
공부 계획
연구는 어떻게 설계됩니까?
디자인 세부사항
코호트 및 개입
그룹/코호트 |
개입 / 치료 |
|---|---|
|
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.
|
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.
|
연구는 무엇을 측정합니까?
주요 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
|
Change from baseline the numerical pain rating scale (NRS) at 12,24,36,48 months
기간: 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.
|
Pain will be evaluated at baseline and 4 follow-ups (12.24.36.48 months).
|
2차 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
|
Change from baseline the pain disability questionnaire (PDQ) at 12,24,36,48 months
기간: 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).
|
Disability will be evaluated at baseline and 4 follow-ups (12,24,36,48 months)
|
기타 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
|
Change from baseline the tampa scale for kinsiophobia (TSK-11) at 12,24,36,48 months
기간: 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
|
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
기간: 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
|
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
기간: 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
|
Pain acceptance will be evaluated at baseline and 4 follow-ups (12,24,36,48 months)
|
|
Change from baseline the pain self-efficacy questionnaire (PSEQ) at 12,24,36,48 months
기간: 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.
|
Self-efficacy will be evaluated at baseline and 4 follow-ups (12,24,36,48 months)
|
공동 작업자 및 조사자
연구 기록 날짜
연구 주요 날짜
연구 시작 (실제)
기본 완료 (실제)
연구 완료 (실제)
연구 등록 날짜
최초 제출
QC 기준을 충족하는 최초 제출
처음 게시됨 (실제)
연구 기록 업데이트
마지막 업데이트 게시됨 (실제)
QC 기준을 충족하는 마지막 업데이트 제출
마지막으로 확인됨
추가 정보
이 정보는 변경 없이 clinicaltrials.gov 웹사이트에서 직접 가져온 것입니다. 귀하의 연구 세부 정보를 변경, 제거 또는 업데이트하도록 요청하는 경우 register@clinicaltrials.gov. 문의하십시오. 변경 사항이 clinicaltrials.gov에 구현되는 즉시 저희 웹사이트에도 자동으로 업데이트됩니다. .