Ignite Creation Date:
2025-12-24 @ 3:17 PM
Ignite Modification Date:
2025-12-25 @ 3:23 PM
Study NCT ID:
NCT01043692
Status:
COMPLETED
Last Update Posted:
2013-10-08
First Post:
2009-12-21
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Acceptability of an Acupuncture Intervention in Painful Elderly
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D059350', 'term': 'Chronic Pain'}], 'ancestors': [{'id': 'D010146', 'term': 'Pain'}, {'id': 'D009461', 'term': 'Neurologic Manifestations'}, {'id': 'D012816', 'term': 'Signs and Symptoms'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D015670', 'term': 'Acupuncture Therapy'}], 'ancestors': [{'id': 'D000529', 'term': 'Complementary Therapies'}, {'id': 'D013812', 'term': 'Therapeutics'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NON_RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 60}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2007-10'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2009-06', 'completionDateStruct': {'date': '2008-12', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2013-10-07', 'studyFirstSubmitDate': '2009-12-21', 'studyFirstSubmitQcDate': '2010-01-06', 'lastUpdatePostDateStruct': {'date': '2013-10-08', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2010-01-07', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2008-09', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Taux acceptability of the totality of treatment', 'timeFrame': '6 months'}], 'secondaryOutcomes': [{'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'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['Chronic Pain > 3 months', 'Acupuncture', 'Acceptability', 'Geriatrics'], 'conditions': ['Chronic Pain']}, 'referencesModule': {'references': [{'pmid': '23464643', 'type': 'RESULT', '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.'}]}, 'descriptionModule': {'briefSummary': '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.', 'detailedDescription': '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.\n\nEvaluation\n\n* Acceptability : the proportion of patients who complete the whole treatment ; the acceptability at each acupuncture session is recorded.\n* 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.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '60 Years', 'healthyVolunteers': False, 'eligibilityCriteria': "Inclusion Criteria:\n\n* age \\> 60 years\n* chronic musculoskeletal pain\n* follow up 10 weeks\n* patient or legal representative's agreement to participate and to the informatics treatment of the data\n\nExclusion Criteria:\n\n* acute pain\n* exclusive neurological pain\n* coagulation disorders or anticoagulant curative treatment"}, 'identificationModule': {'nctId': 'NCT01043692', 'acronym': 'ACUPUNCTURE', 'briefTitle': 'Acceptability of an Acupuncture Intervention in Painful Elderly', 'organization': {'class': 'OTHER', 'fullName': 'Assistance Publique - Hôpitaux de Paris'}, 'officialTitle': 'Acceptability of a Strategy Including Acupuncture in the Treatment of MusculoSkeletal Pain in Hospitalised Elderly', 'orgStudyIdInfo': {'id': '2006-AOO534-47'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Acupuncture', 'description': 'Acupuncture in the Treatment of MUSCULOSKELETAR Pain in Hospitalised Elderly', 'interventionNames': ['Other: Acupuncture']}], 'interventions': [{'name': 'Acupuncture', 'type': 'OTHER', 'description': 'Acupuncture in the Treatment of MUSCULOSKELETAR Pain in Hospitalised Elderly', 'armGroupLabels': ['Acupuncture']}]}, 'contactsLocationsModule': {'locations': [{'zip': '93270', 'city': 'Sevran', 'country': 'France', 'facility': 'HOPITAL RENE MURET BIGOTTINI - Dpt Interhosp. Santé Pub.', 'geoPoint': {'lat': 48.94472, 'lon': 2.52746}}], 'overallOfficials': [{'name': 'Marie-France COUILLIOT', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Assistance Publique - Hôpitaux de Paris'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Assistance Publique - Hôpitaux de Paris', 'class': 'OTHER'}, 'collaborators': [{'name': 'Fondation de France', 'class': 'OTHER'}], 'responsibleParty': {'type': 'SPONSOR'}}}}