Acceptability of an Acupuncture Intervention in Painful Elderly (ACUPUNCTURE)

October 7, 2013 updated by: Assistance Publique - Hôpitaux de Paris

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Actual)

60

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • France
      • Sevran, France, 93270
        • HOPITAL RENE MURET BIGOTTINI - Dpt Interhosp. Santé Pub.

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

60 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Non-Randomized
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Acupuncture
Acupuncture in the Treatment of MUSCULOSKELETAR Pain in Hospitalised Elderly
Other: Acupuncture
Acupuncture in the Treatment of MUSCULOSKELETAR Pain in Hospitalised Elderly

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Taux acceptability of the totality of treatment
Time Frame: 6 months
6 months

Secondary Outcome Measures

Outcome Measure
Time Frame
Participation rate
Time Frame: every visit
every visit
Motives behind the acceptance or rejection
Time Frame: at Visit 0 to 8
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
Time Frame: at Visit 0, 6, 9, 10 and 11
at Visit 0, 6, 9, 10 and 11
Pain therapeutic's decrease
Time Frame: every visit
every visit
Patient's benefit - Carers satisfaction (questionnaire)
Time Frame: at Visit 0,6, 9, 10 and 11
at Visit 0,6, 9, 10 and 11

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Assistance Publique - Hôpitaux de Paris

Collaborators

Fondation de France

Investigators

  • Principal Investigator: Marie-France COUILLIOT, Assistance Publique - Hôpitaux de Paris

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

October 1, 2007

Primary Completion (Actual)

September 1, 2008

Study Completion (Actual)

December 1, 2008

Study Registration Dates

First Submitted

December 21, 2009

First Submitted That Met QC Criteria

January 6, 2010

First Posted (Estimate)

January 7, 2010

Study Record Updates

Last Update Posted (Estimate)

October 8, 2013

Last Update Submitted That Met QC Criteria

October 7, 2013

Last Verified

June 1, 2009

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2006-AOO534-47

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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