Acceptability of an Acupuncture Intervention in Painful Elderly

Chronic Pain Clinical Trial

— ACUPUNCTURE  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01043692
• Other study ID #: 2006-AOO534-47
• Status: Completed
• Phase: N/A
• First received: December 21, 2009
• Last updated: October 7, 2013
• Start date: October 2007
• Est. completion date: December 2008

Study information

• Verified date: June 2009
• Source: Assistance Publique - Hôpitaux de Paris
• Contact: n/a
• Is FDA regulated: No
• Health authority: France: Ministry of Health
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 60
• Est. completion date: December 2008
• Est. primary completion date: September 2008
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 60 Years and older

Eligibility

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 Design

Allocation: Non-Randomized, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Chronic Pain

Intervention

Other:
• Acupuncture
Acupuncture in the Treatment of MUSCULOSKELETAR Pain in Hospitalised Elderly

Locations

Country	Name	City	State
France	HOPITAL RENE MURET BIGOTTINI - Dpt Interhosp. Santé Pub.	Sevran

Sponsors (2)

Lead Sponsor	Collaborator
Assistance Publique - Hôpitaux de Paris	Fondation de France

Country where clinical trial is conducted

France, 

References & Publications (1)

Couilliot MF, Darees V, Delahaye G, Ercolano P, Carcaillé 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/jintegrmed2013 — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Taux acceptability of the totality of treatment		6 months	No
Secondary	Participation rate		every visit	No
Secondary	Motives behind the acceptance or rejection		at Visit 0 to 8	No
Secondary	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	No
Secondary	Pain therapeutic's decrease		every visit	No
Secondary	Patient's benefit - Carers satisfaction (questionnaire)		at Visit 0,6, 9, 10 and 11	No