NCT01043692

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
60

participants targeted

Target at P50-P75 for not_applicable chronic-pain

Timeline
Completed

Started Oct 2007

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

October 1, 2007

Completed
11 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2008

Completed
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2008

Completed
1.1 years until next milestone

First Submitted

Initial submission to the registry

December 21, 2009

Completed
17 days until next milestone

First Posted

Study publicly available on registry

January 7, 2010

Completed
Last Updated

October 8, 2013

Status Verified

June 1, 2009

Enrollment Period

11 months

First QC Date

December 21, 2009

Last Update Submit

October 7, 2013

Conditions

Keywords

Chronic Pain > 3 monthsAcupunctureAcceptabilityGeriatrics

Outcome Measures

Primary Outcomes (1)

  • Taux acceptability of the totality of treatment

    6 months

Secondary Outcomes (5)

  • Participation rate

    every visit

  • 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

  • Patient's benefit - Carers satisfaction (questionnaire)

    at Visit 0,6, 9, 10 and 11

Study Arms (1)

Acupuncture

EXPERIMENTAL

Acupuncture in the Treatment of MUSCULOSKELETAR Pain in Hospitalised Elderly

Other: Acupuncture

Interventions

Acupuncture in the Treatment of MUSCULOSKELETAR Pain in Hospitalised Elderly

Acupuncture

Eligibility Criteria

Age60 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

HOPITAL RENE MURET BIGOTTINI - Dpt Interhosp. Santé Pub.

Sevran, 93270, France

Location

Related Publications (1)

  • 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.

MeSH Terms

Conditions

Chronic Pain

Interventions

Acupuncture Therapy

Condition Hierarchy (Ancestors)

PainNeurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Complementary TherapiesTherapeutics

Study Officials

  • Marie-France COUILLIOT

    Assistance Publique - Hôpitaux de Paris

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

December 21, 2009

First Posted

January 7, 2010

Study Start

October 1, 2007

Primary Completion

September 1, 2008

Study Completion

December 1, 2008

Last Updated

October 8, 2013

Record last verified: 2009-06

Locations