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OpenTrials
Completed

NCT Number: NCT01043692

Acceptability of an Acupuncture Intervention in Painful Elderly

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.

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Key information

Conditions

Chronic Pain Neurologic Manifestations Pain Pathological Conditions, Signs and Symptoms Signs and Symptoms

Age range

60 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

HOPITAL RENE MURET BIGOTTINI - Dpt Interhosp. Santé Pub.

Sevran, 93270, France

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Acupuncture

Other

Acupuncture in the Treatment of MUSCULOSKELETAR Pain in Hospitalised Elderly

Primary outcomes

  1. Taux acceptability of the totality of treatment

    Time frame: 6 months

Secondary outcomes

  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

Sponsors and collaborators

Lead sponsor

Assistance Publique - Hôpitaux de Paris

Other

Collaborators

  • Fondation de France

Registry information

Official study title

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

Acronym: ACUPUNCTURE

Important dates

Study start
2007
Primary completion
2008
Study completion
2008
First posted
Jan 7, 2010
Registry last updated
Oct 8, 2013

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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