Ignite Creation Date:
2025-12-24 @ 1:18 PM
Ignite Modification Date:
2026-02-08 @ 5:46 PM
Study NCT ID:
NCT03637595
Status:
TERMINATED
Last Update Posted:
2023-11-01
First Post:
2018-08-16
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Efficacy and Mechanisms of Energy Medicine to Decrease Chronic Knee Pain in Outpatient Settings
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, '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': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 10}}, 'statusModule': {'whyStopped': 'Study lapsed due to COVID-19.', 'overallStatus': 'TERMINATED', 'startDateStruct': {'date': '2019-06-12', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2023-10', 'completionDateStruct': {'date': '2019-11-27', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2023-10-31', 'studyFirstSubmitDate': '2018-08-16', 'studyFirstSubmitQcDate': '2018-08-16', 'lastUpdatePostDateStruct': {'date': '2023-11-01', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2018-08-20', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2019-11-27', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Pain Level measured by 11- Point Numeric Rating Scale (NRS)', 'timeFrame': '18 Months', 'description': '11 point scale (0-10) asking patient leve of discomfort. A state of no pain is "0" and worst pain is "10"'}, {'measure': 'Pain Level measured by Visual Analog Scale (VAS)', 'timeFrame': '18 Months', 'description': 'used for quantification of pain; psychometric response scales used to measure subjective characteristics or attitudes and have been used in the past for a multitude of disorders, as well as in market research and social science investigations, among others'}, {'measure': 'Self Reported Physical Function measured y the Western Ontario and McMaster Universities Ostheoarthritic Index (WOMAC)', 'timeFrame': '18 Months', 'description': 'self-administered questionnaire consisting of 24 items divided into 3 subscales:\\[1\\]\n\n* Pain (5 items): during walking, using stairs, in bed, sitting or lying, and standing upright\n* Stiffness (2 items): after first waking and later in the day\n* Physical Function (17 items): using stairs, rising from sitting, standing, bending, walking, getting in / out of a car, shopping, putting on / taking off socks, rising from bed, lying in bed, getting in / out of bath, sitting, getting on / off toilet, heavy domestic duties, light domestic duties'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Ostheoporosis of the Knee']}, 'descriptionModule': {'briefSummary': 'This study will assess the efficacy and mechanisms behind Energy Medicine in reducing chronic knee pain within an outpatient setting. This study will investigate a form of Energy Medicine (EM) performed by a natural solo practitioner, using a standard number of three sessions, which will compare to both positive and negative control groups. The positive control group will receive acupuncture and the negative control group will receive a sham intervention.'}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '70 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': "Inclusion Criteria:\n\n* Presence of knee pain lasting for at least six months\n* No radiation of knee pain\n* No acupuncture treatments in the previous six months\n* Failure to respond completely to the medications given by their orthopedic or pain management specialist\n* Knee pain on most days (4 out of 7 days of the week) with average self-reported severity of 4 or more out of 10 on a numeric rating scale (NRS)\n* Complaints of morning stiffness lasting less than 30 minutes\n* Not be in active physical therapy (PT) for the duration of the trial.\n* Adult patients ≥18 years of age\n* English speaking\n\nExclusion Criteria:\n\n* Any concurrent diagnosis of systemic disease\n* Other concurrent treatments such as massage, Acupcunture, PT or any kind of Energy Medicine\n* Bleeding disorder\n* Trypanophobia (fear of needles or injections).\n* Have medical condition that causes difficulty in saliva production/collection (i.e.: Sjogren's Syndrome)"}, 'identificationModule': {'nctId': 'NCT03637595', 'briefTitle': 'Efficacy and Mechanisms of Energy Medicine to Decrease Chronic Knee Pain in Outpatient Settings', 'organization': {'class': 'OTHER', 'fullName': 'NYU Langone Health'}, 'officialTitle': 'Efficacy and Mechanisms of Energy Medicine to Decrease Chronic Knee Pain in Outpatient Settings', 'orgStudyIdInfo': {'id': '18-00600'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'Positive Control Group', 'description': 'Acupuncture', 'interventionNames': ['Procedure: Acupuncture']}, {'type': 'SHAM_COMPARATOR', 'label': 'Negative Control Group', 'description': 'Sham Intervention', 'interventionNames': ['Procedure: Sham Energy Medicine']}, {'type': 'EXPERIMENTAL', 'label': 'Energy Medicine (EM) Intervention', 'description': 'Energy Medicine by an energy medicine practitioner', 'interventionNames': ['Procedure: Enery Medicine Intervention']}], 'interventions': [{'name': 'Acupuncture', 'type': 'PROCEDURE', 'description': '3 sessions of acupuncture will be the reference therapy against which the energy medicine intervention is being compared.', 'armGroupLabels': ['Positive Control Group']}, {'name': 'Enery Medicine Intervention', 'type': 'PROCEDURE', 'description': '3 sessions performed by Energy Medicine practitioner, who will perform an assessment followed by the intervention.', 'armGroupLabels': ['Energy Medicine (EM) Intervention']}, {'name': 'Sham Energy Medicine', 'type': 'PROCEDURE', 'description': 'a non-energy trained confederate to be determined from the clinical research coordinators and non traditional volunteers enrolled administering assessments and providing therapeutic company.', 'armGroupLabels': ['Negative Control Group']}]}, 'contactsLocationsModule': {'locations': [{'zip': '10016', 'city': 'New York', 'state': 'New York', 'country': 'United States', 'facility': 'NYU Langone Health', 'geoPoint': {'lat': 40.71427, 'lon': -74.00597}}], 'overallOfficials': [{'name': 'Barbara A Siminovich-blok, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'NYU Langone Medical Center'}]}, 'ipdSharingStatementModule': {'infoTypes': ['STUDY_PROTOCOL', 'ICF'], 'timeFrame': 'Beginning 9 months and ending 36 months following article publication.', 'ipdSharing': 'YES', 'description': 'Individual participant data that underlie the results reported in this article, after deidentification (text, tables, figures, and appendices).', 'accessCriteria': 'Requests should be directed to siminb01@nyumc.org To gain access, data requestors will need to sign a data access agreement.'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'NYU Langone Health', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}