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Acceptability of an Acupuncture Intervention in Painful Elderly (ACUPUNCTURE)

Primary Purpose

Chronic Pain

Status
Completed
Phase
Not Applicable
Locations
France
Study Type
Interventional
Intervention
Acupuncture
Sponsored by
Assistance Publique - Hôpitaux de Paris
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Chronic Pain focused on measuring Chronic Pain > 3 months, Acupuncture, Acceptability, Geriatrics

Eligibility Criteria

60 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • 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

Exclusion Criteria:

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

Sites / Locations

  • HOPITAL RENE MURET BIGOTTINI - Dpt Interhosp. Santé Pub.

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Acupuncture

Arm Description

Acupuncture in the Treatment of MUSCULOSKELETAR Pain in Hospitalised Elderly

Outcomes

Primary Outcome Measures

Taux acceptability of the totality of treatment

Secondary Outcome Measures

Participation rate
Motives behind the acceptance or rejection
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
Pain therapeutic's decrease
Patient's benefit - Carers satisfaction (questionnaire)

Full Information

First Posted
December 21, 2009
Last Updated
October 7, 2013
Sponsor
Assistance Publique - Hôpitaux de Paris
Collaborators
Fondation de France
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1. Study Identification

Unique Protocol Identification Number
NCT01043692
Brief Title
Acceptability of an Acupuncture Intervention in Painful Elderly
Acronym
ACUPUNCTURE
Official Title
Acceptability of a Strategy Including Acupuncture in the Treatment of MusculoSkeletal Pain in Hospitalised Elderly
Study Type
Interventional

2. Study Status

Record Verification Date
June 2009
Overall Recruitment Status
Completed
Study Start Date
October 2007 (undefined)
Primary Completion Date
September 2008 (Actual)
Study Completion Date
December 2008 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Assistance Publique - Hôpitaux de Paris
Collaborators
Fondation de France

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief Summary
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.
Detailed Description
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Chronic Pain
Keywords
Chronic Pain > 3 months, Acupuncture, Acceptability, Geriatrics

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
60 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Acupuncture
Arm Type
Experimental
Arm Description
Acupuncture in the Treatment of MUSCULOSKELETAR Pain in Hospitalised Elderly
Intervention Type
Other
Intervention Name(s)
Acupuncture
Intervention Description
Acupuncture in the Treatment of MUSCULOSKELETAR Pain in Hospitalised Elderly
Primary Outcome Measure Information:
Title
Taux acceptability of the totality of treatment
Time Frame
6 months
Secondary Outcome Measure Information:
Title
Participation rate
Time Frame
every visit
Title
Motives behind the acceptance or rejection
Time Frame
at Visit 0 to 8
Title
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
Time Frame
at Visit 0, 6, 9, 10 and 11
Title
Pain therapeutic's decrease
Time Frame
every visit
Title
Patient's benefit - Carers satisfaction (questionnaire)
Time Frame
at Visit 0,6, 9, 10 and 11

10. Eligibility

Sex
All
Minimum Age & Unit of Time
60 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: 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 Exclusion Criteria: acute pain exclusive neurological pain coagulation disorders or anticoagulant curative treatment
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Marie-France COUILLIOT
Organizational Affiliation
Assistance Publique - Hôpitaux de Paris
Official's Role
Principal Investigator
Facility Information:
Facility Name
HOPITAL RENE MURET BIGOTTINI - Dpt Interhosp. Santé Pub.
City
Sevran
ZIP/Postal Code
93270
Country
France

12. IPD Sharing Statement

Citations:
PubMed Identifier
23464643
Citation
Couilliot MF, Darees V, Delahaye G, Ercolano P, Carcaille M, Vytopilova P, Tenenbaum B, Vicaut E. Acceptability of an acupuncture intervention for geriatric chronic pain: an open pilot study. J Integr Med. 2013 Jan;11(1):26-31. doi: 10.3736/jintegrmed2013005.
Results Reference
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Acceptability of an Acupuncture Intervention in Painful Elderly

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