Ignite Creation Date:
2025-12-24 @ 2:17 PM
Ignite Modification Date:
2025-12-30 @ 5:23 AM
Study NCT ID:
NCT00967395
Status:
COMPLETED
Last Update Posted:
2012-01-06
First Post:
2009-08-26
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Effect of Healing on Rheumatoid Arthritis
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D001172', 'term': 'Arthritis, Rheumatoid'}], 'ancestors': [{'id': 'D001168', 'term': 'Arthritis'}, {'id': 'D007592', 'term': 'Joint Diseases'}, {'id': 'D009140', 'term': 'Musculoskeletal Diseases'}, {'id': 'D012216', 'term': 'Rheumatic Diseases'}, {'id': 'D003240', 'term': 'Connective Tissue Diseases'}, {'id': 'D017437', 'term': 'Skin and Connective Tissue Diseases'}, {'id': 'D001327', 'term': 'Autoimmune Diseases'}, {'id': 'D007154', 'term': 'Immune System Diseases'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'QUADRUPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'HEALTH_SERVICES_RESEARCH', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 90}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2008-01'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2012-01', 'completionDateStruct': {'date': '2009-09', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2012-01-05', 'studyFirstSubmitDate': '2009-08-26', 'studyFirstSubmitQcDate': '2009-08-26', 'lastUpdatePostDateStruct': {'date': '2012-01-06', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2009-08-27', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2009-01', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'DAS28', 'timeFrame': '8 weeks follow-up'}], 'secondaryOutcomes': [{'measure': 'Colour Doppler fraction', 'timeFrame': '8 weeks follow-up'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'conditions': ['Rheumatoid Arthritis']}, 'descriptionModule': {'briefSummary': "The hypothesis is that healing may influence the patient's general status by altering psychological as well as other body functions of importance for the rheumatoid arthritis. This is tested in a three group design with a control group and two groups receiving healing with or without a healer present. The study is randomized and double blind.", 'detailedDescription': "The central claim of healers is that this process facilitates self-healing in the patient. Spiritual healing includes several categories, including 'therapeutic touch' and 'intercessory prayer', and the healing may be attributed to God, spirits, universal forces or energies, biological healing energies residing in the healer, or self-healing powers or energies thought to reside latent in the healed organism. The highly controversial hypothesized effects of distant or spiritual healing contradict our traditional sense of reality and are in conflict with what is generally viewed as being in correspondence with modern science."}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Patients with rheumatoid arthritis in a stable medication the past 3 months written informed consent\n\nExclusion Criteria:\n\n* Not able to arrange own transport, language problems'}, 'identificationModule': {'nctId': 'NCT00967395', 'acronym': 'RAhealing', 'briefTitle': 'Effect of Healing on Rheumatoid Arthritis', 'organization': {'class': 'OTHER', 'fullName': 'Frederiksberg University Hospital'}, 'officialTitle': 'Effect of Healing on Rheumatoid Arthritis: a Three-arm Double-blind, Randomized, Controlled Trial', 'orgStudyIdInfo': {'id': '(KF) 01-123/04'}, 'secondaryIdInfos': [{'id': '(KF) 01-123/04'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Healing', 'description': 'patients receive healing while blindfolded and with hearing protector. The healer is behind a screen and not allowed to speak with the subject.', 'interventionNames': ['Other: Healing']}, {'type': 'SHAM_COMPARATOR', 'label': 'Sham healing', 'description': 'Same design of room as with the healing, while in this case a student is behind the screen', 'interventionNames': ['Other: Sham healing']}, {'type': 'NO_INTERVENTION', 'label': 'Control', 'description': 'Business as usual in the third arm'}], 'interventions': [{'name': 'Healing', 'type': 'OTHER', 'otherNames': ['"active healing"'], 'description': 'Healing in our study is given be a healer "no-touch", who just has to be present in the room.', 'armGroupLabels': ['Healing']}, {'name': 'Sham healing', 'type': 'OTHER', 'otherNames': ['"placebo healing"'], 'description': 'Sham Healing in our study is given be a student "no-touch", who just has to be present in the room.', 'armGroupLabels': ['Sham healing']}]}, 'contactsLocationsModule': {'overallOfficials': [{'name': 'Bente Danneskiold-Samsøe, Professor', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Frederiksberg University Hospital'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Henning Bliddal', 'class': 'OTHER'}, 'collaborators': [{'name': 'The IMK Foundation', 'class': 'UNKNOWN'}, {'name': 'The Danish Rheumatism Association', 'class': 'OTHER'}, {'name': 'Oak Foundation', 'class': 'OTHER'}], 'responsibleParty': {'type': 'SPONSOR_INVESTIGATOR', 'investigatorTitle': 'Professor', 'investigatorFullName': 'Henning Bliddal', 'investigatorAffiliation': 'Frederiksberg University Hospital'}}}}