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临床试验/NCT01043692
NCT01043692已完成不适用

Acceptability of a Strategy Including Acupuncture in the Treatment of MusculoSkeletal Pain in Hospitalised Elderly

Assistance Publique - Hôpitaux de Paris2 个研究点 分布在 1 个国家目标入组 60 人开始时间: 2007年10月最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
60
试验地点
2
主要终点
Taux acceptability of the totality of treatment

研究概览

简要总结

The aim is to investigate the feasibility and efficacy of an acupuncture intervention on persistent MusculoSkeletar pain in a long-term geriatric hospital care ward population. The main issue is the acceptability of this type of complementary and alternative medicine in older people, although the efficacy on pain is assessed too.

详细描述

The first 60 patients wanting to participate are enrolled. For the impaired patients, family or legal representing is solicited. The Regional Ethic Committee agreement was granted. The intervention consists in 8 acupuncture sessions.

Evaluation

  • Acceptability : the proportion of patients who complete the whole treatment ; the acceptability at each acupuncture session is recorded.
  • Pain : Dolorous Scale . The evaluation is based on pre and post treatment variations. As a high proportion of patients have cognitive impairment, the behavioural pain scale "dolorous" has been chosen after staffs training for all patients, although "extra " auto evaluation is used when possible (EVS). Evaluation takes place after 5 sessions and after the end of the intervention as well as 2 and 4 weeks after the interventionProfessional carers' satisfaction is recorded.

研究设计

研究类型
Interventional
分配方式
Non Randomized
干预模型
Single Group
主要目的
Treatment
盲法
None

入排标准

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

入选标准

  • age > 60 years
  • chronic musculoskeletal pain
  • follow up 10 weeks
  • patient or legal representative's agreement to participate and to the informatics treatment of the data

排除标准

  • acute pain
  • exclusive neurological pain
  • coagulation disorders or anticoagulant curative treatment

结局指标

主要结局

Taux acceptability of the totality of treatment

时间窗: 6 months

次要结局

  • Participation rate(every visit)
  • Patient's benefit - Carers satisfaction (questionnaire)(at Visit 0,6, 9, 10 and 11)
  • Motives behind the acceptance or rejection(at Visit 0 to 8)
  • Pain decrease assessment : DOLOPLUS score (observer-assessed evaluation of pain) before/ater intervention, for all the patients Simple descriptive pain intensity scale (VS) (self assessment evaluation of pain) for communicative patients(at Visit 0, 6, 9, 10 and 11)
  • Pain therapeutic's decrease(every visit)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (2)

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