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临床试验/NCT03803501
NCT03803501已完成不适用

Effectiveness of a Condensed Functional Restoration Program for Patients With Chronic Low Back Pain: a Study of 193 Patients

Pitié-Salpêtrière Hospital1 个研究点 分布在 1 个国家目标入组 193 人开始时间: 2014年4月1日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
193
试验地点
1
主要终点
Oswestry disability index

研究概览

简要总结

The aim was to assess the effectiveness of a condensed functional restoration program (CFRP) for patients with chronic low back pain and professional activity.

Methods: Longitudinal 1 to 3 months study of patients with non-specific chronic low back pain in one tertiary care hospital, participating in a CFRP (complex interprofessional intervention over 4 days). The primary outcome was the Oswestry Disability Index (ODI) (0-100 scale). Secondary outcomes included pain, quality of life (EQ5D), patient acceptable symptom state, presenteeism, absenteeism and psychological distress (Hospital Anxiety and Depression scale). Outcomes were compared using paired sample Student's t-test or Chi2 between baseline and last follow-up. Logistic regression was used to identify factors associated with better response (improvement of ODI higher than 12.8) and included baseline demographic, psychological and physical assessment variables.

研究设计

研究类型
Observational
观察模型
Cohort
时间视角
Prospective

入排标准

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

入选标准

  • •non-specific cLBP (>3 months) with or without radicular pain, not currently in prolonged sick leave, no current indication for surgery, fluent in French, difficulties to maintain daily physical activity due to LBP with Oswestry Disability Index and lumbar and radicular pain at baseline and at end of intervention or 3-month follow-up available.

排除标准

  • •specific LBP and organic contraindication to physical exercise.

结局指标

主要结局

Oswestry disability index

时间窗: change between baseline score and last follow-up data, i.e. data at 3 months follow-up or score at end of intervention if not available

gives a subjective percentage score of level of function (disability) on a 0 to 100 scale, 100 being the highest disability state

次要结局

  • lumbar pain(change between baseline score and last follow-up data, i.e. data at 3 months follow-up or score at end of intervention if not available)
  • World Health Organisation Health and Work Performance Questionnaire for absolute presenteeism(change between baseline score and last follow-up data, i.e. data at 3 months follow-up or score at end of intervention if not available)
  • Radicular pain(change between baseline score and last follow-up data, i.e. data at 3 months follow-up or score at end of intervention if not available)
  • quality of life(change between baseline score and last follow-up data, i.e. data at 3 months follow-up or score at end of intervention if not available)
  • patient acceptable symptom state(change between baseline score and last follow-up data, i.e. data at 3 months follow-up or score at end of intervention if not available)
  • relative absenteeism(change between baseline score and last follow-up data, i.e. data at 3 months follow-up or score at end of intervention if not available)
  • psychological distress(change between baseline score and last follow-up data, i.e. data at 3 months follow-up or score at end of intervention if not available)

研究者

发起方
Pitié-Salpêtrière Hospital
申办方类型
Other
责任方
Principal Investigator
主要研究者

Thomas Davergne

Physiotherapist, Master of Science and PhD candidate, principal investigator

Pitié-Salpêtrière Hospital

研究点 (1)

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