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临床试验/NCT03963440
NCT03963440已完成不适用

Cross-cultural Validation in French Language of the Questionnaire EARS Adapted to the Chronic Low Back Pain

University Hospital, Clermont-Ferrand10 个研究点 分布在 1 个国家目标入组 120 人开始时间: 2019年2月1日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
120
试验地点
10
主要终点
Psychometric properties of the French questionnaire EARS

研究概览

简要总结

The main objective of this work is to validate in French the questionnaire EARS, adapted to chronic low back pain.

Physical exercise is often recognized as necessary for primary and secondary prevention and treatment of chronic diseases. This is particularly true of chronic low back pain. It is therefore of paramount importance that compliance with such treatment be assessed to allow for readjustments, as well as drug treatment. No gold standard6-7 measured patient adherence to exercise programs until the creation of the EARS in 2016 by E.Godfrey and his team (Exercise Adherence Rating Scale, literally "joining physical exercise programs")

EARS is a reliable and validated psychometric assessment questionnaire that assesses adherence to prescribed physical exercise in chronic low back pain.

详细描述

Self-management of the patient to perform these exercises involves good collaboration with the care prescriber, leaving patients to manage and monitor their health. Long-term adherence to care programs, including physical exercise, is paramount for these patients in order to maintain a beneficial long-term effect, which is the case in non-specific chronic low back pain. However, evidence shows that compliance levels following a physical exercise prescription are low, limiting the benefits this could bring.

Currently, EARS is validated for chronic low back pain in its English version. To our knowledge and to the knowledge of the questionnaire's author, E.Godfrey, there are no other studies that have examined the validation of EARS in the French language for chronic low back pain.

Patients will be asked to complete a series of questionnaires after completing the non-opposition form. The management of non-specific chronic low back pain also requires evaluation through questionnaires, in accordance with the usual practices of the services participating in the study. No intervention will be taken.

研究设计

研究类型
Interventional
分配方式
Na
干预模型
Single Group
主要目的
Screening
盲法
None

入排标准

年龄范围
18 Years 至 —(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Both sexes
  • Adult (>18 years old)
  • Chronic Low Back Pain evolving for at least 3 months
  • Acceptance to participate in the study
  • Patients affiliated to a social security scheme (beneficiary entitled)

排除标准

  • Patient under guardianship, or protection of justice.
  • Patient in the incapacity to answer the questionnaire.

研究组 & 干预措施

Cohorte 1

Experimental

Inclusion and first questionnaires period (10 questionnaires), after geting consent, during normal patient consultation schedule for functional restoration program of the lumbar spine (1 to 3 weeks hospital in day care).

Second questionnaire period at 48h (Only EARS questionnaire) Third questionnaires period (10 questionnaires) at the end of the restoration program hospital care.

Fourth and last questionnaires period (10 questionnaires) at 3 months during a normal patient follow-up consultation No additional appointments.

干预措施: Exercise Adherence Rating Scale (EARS) (Other)

结局指标

主要结局

Psychometric properties of the French questionnaire EARS

时间窗: 0 day, 2 days, 15 days, 3 months

(acceptability, internal validity, reproducibility, convergent validity and validity of structure against external criteria)

次要结局

  • The fears and the faiths measured by questionnaire FABQ(at day 0, 15 days, 3 months)
  • Evaluation of the burden, bound to the realization of the physical exercises by questionnaire ETBQ(at day 0, 15 days, 3 months)
  • The 14-item Beliefs and Behaviors Questionnaire (BBQ) measures beliefs, experiences and adherent behavior related with Low Back pain(at day 0, 15 days, 3 months)
  • The knowledge of emotional state measured by questionnaire HAD(at day 0, 15 days, 3 months)
  • Self-assessment of the incapacity, that deals with the echo on the everyday life measured by questionnaire QUEBEC(at day 0, 15 days, 3 months)
  • Patient Global Impression of Change by Scale PGIC(15 days, 3 months)
  • The personal efficacy by means of the questionnaire ASES "Arthritis Self-Efficacy Scale"(at day 0, 15 days, 3 months)
  • The evaluation of the self-efficiency perceived of return in the work by means of the questionnaire RTWSE (10 items)(at day 0, 15 days, 3 months)
  • Level of physical activity measured by short questionnaire IPAQ(at day 0, 15 days, 3 months)

研究者

发起方
University Hospital, Clermont-Ferrand
申办方类型
Other
责任方
Sponsor

研究点 (10)

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