Clinical trial NCT01043692: Acceptability of an Acupuncture Intervention in Painful Elderly
Official title: Acceptability of a Strategy Including Acupuncture in the Treatment of MusculoSkeletal Pain in Hospitalised Elderly
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Chronic Pain
Keywords: Chronic Pain > 3 months
Acupuncture
Acceptability
Geriatrics
Lead sponsor: Assistance Publique - Hôpitaux de Paris
Sponsor class: OTHER
Collaborators: name: Fondation de France
First posted: 2010-01-07
Enrollment: 60
Sex: ALL
Minimum age (years): 60
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.

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

Primary outcomes:
measure: Taux acceptability of the totality of treatment
timeFrame: 6 months
Secondary outcomes:
measure: Participation rate
timeFrame: every visit
measure: Motives behind the acceptance or rejection
timeFrame: at Visit 0 to 8
measure: 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
timeFrame: at Visit 0, 6, 9, 10 and 11
measure: Pain therapeutic's decrease
timeFrame: every visit
measure: Patient's benefit - Carers satisfaction (questionnaire)
timeFrame: at Visit 0,6, 9, 10 and 11
Other outcomes:
Locations:
city: Sevran
country: France
facility: HOPITAL RENE MURET BIGOTTINI - Dpt Interhosp. Santé Pub.
Study officials:
affiliation: Assistance Publique - Hôpitaux de Paris
name: Marie-France COUILLIOT
role: PRINCIPAL_INVESTIGATOR
References:
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.