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临床试验/NCT02894125
NCT02894125已完成不适用

Evaluation of the Effectiveness of a SPA Therapy to "Neyrac-les-Bains" to the Old Subject (60-80 Years Old) With a Chronic Low Back Pain.

University Hospital, Clermont-Ferrand1 个研究点 分布在 1 个国家目标入组 100 人开始时间: 2015年7月最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
100
试验地点
1
主要终点
Pain's estimation by the digital scale

研究概览

简要总结

Low back pain is considered to be chronic if it has been present for longer than three months.

This pathology is extremely frequent with an annual incidence between 5 in 10 % of the general population. Thus she is frequently met in general medicine, in particular to the ageing subject. It is the 2nd motive for consultation.

The Chronic Low Back Pain is a mild pathology the forecast of which is in the favorable great majority of the cases but she pulled a socioeconomic cost mattering with a poly-consumption of care, in private individuals.

The primary objective of this study is to determine the impact of a 3 months SPA Therapy on the Chronic Low Back Pain in older adults (from 60 to 80 years old) realizing a SPA Therapy of 3 weeks to "Neyrac-les-Bains".

详细描述

Realization of the protocol :

  1. Selection of the patients (realized during the consultation of programming in the beginning of the SPA Therapy). They are 2 thermal doctors of "Neyrac-les-Bains" (1 general practitioner with formation of thermal medicine and a rheumatologist) which include the eligible patients in this study during the visit of the beginning of SPA Therapy.
  2. They will put back to the patients the Inform Consent Form, the Form of non-opposition and the 1st questionnaire (J0). The nurse of the SPA Therapy will be at their disposal to help them to fill the questionnaire if need.

An urn will be arranged in the entrance hall of Neyrac- les-Bains to get back the filled questionnaires (J0 and J21).

Patients will follow the conventional SPA Therapy of 3 weeks without a specific changes or modification of the care provided.

Feedback :

研究设计

研究类型
Observational

入排标准

年龄范围
60 Years 至 80 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • - Both sexes
  • 60-80 years old
  • Realizing a SPA Therapy of 3 weeks.
  • Presenting a mechanical pain of the rachis lumbar vertebra > 3 months
  • Possible irradiation up to the knee (cruralgia / sciatalgie truncated)
  • Cooperation and understanding allowing to conform in a strict way to the conditions planned by the study
  • Acceptance to participate in the study (non-opposition)

排除标准

  • - < 60-year-old patients or > 80 years
  • Inflammatory, tumoral, traumatic or infectious rheumatism
  • Surgery of the back
  • SPA Therapy dating less than 6 months
  • Evolutionary slipped disc
  • Disorders(confusions) of the concentration or the compression of the written or oral French language making impossible the realization of the study
  • The pain estimated by the digital scale = 0 in the inclusion

结局指标

主要结局

Pain's estimation by the digital scale

时间窗: at 3 months

次要结局

  • fears and the faiths with the FABQ (physical dimension only)(at 0 day , 21 days, 3 months, 6 months)
  • consumption of analgesic estimated by a standardized collection(at 21 days, 3 months, 6 months)
  • functional incapacity by means of the questionnaire "Oswestry Disability index"(at 0 days, 21 days, 3 months and 6 months)
  • personal efficacy by means of the French questionnaire ASES "Arthritis Self Efficacy Scale"(at 0 day , 21 days, 3 months, 6 months)
  • expectations and fears by means of individual interview or focus groups by means of the quantitative questionnaire for qualitative analysis.(at 0 day)

研究者

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

研究点 (1)

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