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Acceptability of an Acupuncture Intervention in Painful Elderly (ACUPUNCTURE)

This study has been completed.
Sponsor:
Collaborator:
Fondation de France
Information provided by:
Assistance Publique - Hôpitaux de Paris
ClinicalTrials.gov Identifier:
NCT01043692
First received: December 21, 2009
Last updated: January 28, 2010
Last verified: June 2009
History of Changes
  Purpose

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.


Condition Intervention
Chronic Pain
 Other: Acupuncture

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Acceptability of a Strategy Including Acupuncture in the Treatment of MusculoSkeletal Pain in Hospitalised Elderly

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Assistance Publique - Hôpitaux de Paris:

Primary Outcome Measures:
  • Taux acceptability of the totality of treatment [ Time Frame: 6 months ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Participation rate [ Time Frame: every visit ] [ Designated as safety issue: No ]
  • Motives behind the acceptance or rejection [ Time Frame: at Visit 0 to 8 ] [ Designated as safety issue: No ]
  • 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 ] [ Designated as safety issue: No ]
  • Pain therapeutic's decrease [ Time Frame: every visit ] [ Designated as safety issue: No ]
  • Patient's benefit - Carers satisfaction (questionnaire) [ Time Frame: at Visit 0,6, 9, 10 and 11 ] [ Designated as safety issue: No ]

Enrollment: 60
Study Start Date: October 2007
Study Completion Date: December 2008
Primary Completion Date: September 2008 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Acupuncture
Acupuncture in the Treatment of MUSCULOSKELETAR Pain in Hospitalised Elderly
 Other: Acupuncture
Acupuncture in the Treatment of MUSCULOSKELETAR Pain in Hospitalised Elderly

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.
  Eligibility

Ages Eligible for Study:   60 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01043692

Locations
France
HOPITAL RENE MURET BIGOTTINI - Dpt Interhosp. Santé Pub.
Sevran, France, 93270
Sponsors and Collaborators
Assistance Publique - Hôpitaux de Paris
Fondation de France
Investigators
Principal Investigator: Marie-France COUILLIOT Assistance Publique - Hôpitaux de Paris
  More Information

No publications provided

Responsible Party: Eric Vicaut, Department of clinical research and development
ClinicalTrials.gov Identifier: NCT01043692     History of Changes
Other Study ID Numbers: 2006-AOO534-47
Study First Received: December 21, 2009
Last Updated: January 28, 2010
Health Authority: France: Ministry of Health

Keywords provided by Assistance Publique - Hôpitaux de Paris:
Chronic Pain > 3 months
Acupuncture
Acceptability
Geriatrics

ClinicalTrials.gov processed this record on May 21, 2013