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Acceptability of an Acupuncture Intervention in Painful Elderly (ACUPUNCTURE)

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ClinicalTrials.gov Identifier: NCT01043692
Recruitment Status : Completed
First Posted : January 7, 2010
Last Update Posted : October 8, 2013
Sponsor:
Collaborator:
Fondation de France
Information provided by (Responsible Party):
Assistance Publique - Hôpitaux de Paris

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.

Condition or disease Intervention/treatment Phase
Chronic Pain Other: Acupuncture Not Applicable

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  (Clinical Trial)
Actual Enrollment : 60 participants
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Acceptability of a Strategy Including Acupuncture in the Treatment of MusculoSkeletal Pain in Hospitalised Elderly
Study Start Date : October 2007
Actual Primary Completion Date : September 2008
Actual Study Completion Date : December 2008

Resource links provided by the National Library of Medicine

U.S. FDA Resources

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



Primary Outcome Measures :
  1. Taux acceptability of the totality of treatment [ Time Frame: 6 months ]

Secondary Outcome Measures :
  1. Participation rate [ Time Frame: every visit ]
  2. Motives behind the acceptance or rejection [ Time Frame: at Visit 0 to 8 ]
  3. 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 ]
  4. Pain therapeutic's decrease [ Time Frame: every visit ]
  5. Patient's benefit - Carers satisfaction (questionnaire) [ Time Frame: at Visit 0,6, 9, 10 and 11 ]


Information from the National Library of Medicine

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Ages Eligible for Study:   60 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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

Publications of Results:
Responsible Party: Assistance Publique - Hôpitaux de Paris
ClinicalTrials.gov Identifier: NCT01043692     History of Changes
Other Study ID Numbers: 2006-AOO534-47
First Posted: January 7, 2010    Key Record Dates
Last Update Posted: October 8, 2013
Last Verified: June 2009

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

Additional relevant MeSH terms:
Chronic Pain
Pain
Neurologic Manifestations
Nervous System Diseases
Signs and Symptoms