Ignite Creation Date:
2025-12-24 @ 5:32 PM
Ignite Modification Date:
2025-12-28 @ 5:15 AM
Study NCT ID:
NCT00447668
Status:
COMPLETED
Last Update Posted:
2017-10-13
First Post:
2007-03-13
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Effect of Yoga Vs. Stretching on Chronic Back Pain
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'interventionBrowseModule': {'meshes': [{'id': 'D015013', 'term': 'Yoga'}, {'id': 'D015444', 'term': 'Exercise'}], 'ancestors': [{'id': 'D026441', 'term': 'Mind-Body Therapies'}, {'id': 'D000529', 'term': 'Complementary Therapies'}, {'id': 'D013812', 'term': 'Therapeutics'}, {'id': 'D026443', 'term': 'Spiritual Therapies'}, {'id': 'D026241', 'term': 'Exercise Movement Techniques'}, {'id': 'D026741', 'term': 'Physical Therapy Modalities'}, {'id': 'D009043', 'term': 'Motor Activity'}, {'id': 'D009068', 'term': 'Movement'}, {'id': 'D009142', 'term': 'Musculoskeletal Physiological Phenomena'}, {'id': 'D055687', 'term': 'Musculoskeletal and Neural Physiological Phenomena'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 210}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2007-03'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2017-10', 'completionDateStruct': {'date': '2011-08', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2017-10-11', 'studyFirstSubmitDate': '2007-03-13', 'studyFirstSubmitQcDate': '2007-03-13', 'lastUpdatePostDateStruct': {'date': '2017-10-13', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2007-03-15', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2009-08', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Back-related function', 'timeFrame': '6 months'}, {'measure': 'Pain', 'timeFrame': '6 months'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'keywords': ['Chronic Low Back Pain', 'Yoga'], 'conditions': ['Chronic Non-specific Low Back Pain']}, 'referencesModule': {'references': [{'pmid': '22025101', 'type': 'DERIVED', 'citation': 'Sherman KJ, Cherkin DC, Wellman RD, Cook AJ, Hawkes RJ, Delaney K, Deyo RA. A randomized trial comparing yoga, stretching, and a self-care book for chronic low back pain. Arch Intern Med. 2011 Dec 12;171(22):2019-26. doi: 10.1001/archinternmed.2011.524. Epub 2011 Oct 24.'}, {'pmid': '20356395', 'type': 'DERIVED', 'citation': 'Sherman KJ, Cherkin DC, Cook AJ, Hawkes RJ, Deyo RA, Wellman R, Khalsa PS. Comparison of yoga versus stretching for chronic low back pain: protocol for the Yoga Exercise Self-care (YES) trial. Trials. 2010 Mar 31;11:36. doi: 10.1186/1745-6215-11-36.'}]}, 'descriptionModule': {'briefSummary': 'This study will compare the effectiveness of yoga classes, exercise classes, and a self-care book in the management of pain and function for people with low back pain.It will also for physical, psychological and physiological factors associated with improvement in back pain.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT'], 'maximumAge': '64 Years', 'minimumAge': '20 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Group Health Cooperative enrollee\n* Uncomplicated low back pain\n* At least moderate pain levels\n\nExclusion Criteria:\n\n* Sciatica persisting 3 or more months after physician visit\n* History of cancer (other than nonmelanoma skin cancer)\n* Severe disk problems\n* Unstable medical conditions\n* Back surgery within past 3 years\n* Physically unable to do the yoga or exercise classes and homework\n* Unable to attend classes\n* Currently doing yoga\n* Taken yoga or exercise class for back pain within past year\n* Currently in litigation for back pain\n* Seeking other treatment for back pain'}, 'identificationModule': {'nctId': 'NCT00447668', 'acronym': 'YES', 'briefTitle': 'Effect of Yoga Vs. Stretching on Chronic Back Pain', 'organization': {'class': 'OTHER', 'fullName': 'Kaiser Permanente'}, 'officialTitle': 'Effect of Yoga Vs. Stretching on Chronic Back Pain', 'orgStudyIdInfo': {'id': 'U01AT003208', 'link': 'https://reporter.nih.gov/quickSearch/U01AT003208', 'type': 'NIH'}, 'secondaryIdInfos': [{'id': 'U01AT003208', 'link': 'https://reporter.nih.gov/quickSearch/U01AT003208', 'type': 'NIH'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': '1', 'interventionNames': ['Behavioral: Yoga']}, {'type': 'ACTIVE_COMPARATOR', 'label': '2', 'description': 'Exercise', 'interventionNames': ['Behavioral: Exercise']}, {'type': 'ACTIVE_COMPARATOR', 'label': '3', 'description': 'Self-care book recommendations', 'interventionNames': ['Behavioral: Self-care book recommendations']}], 'interventions': [{'name': 'Yoga', 'type': 'BEHAVIORAL', 'description': 'Yoga for back pain', 'armGroupLabels': ['1']}, {'name': 'Exercise', 'type': 'BEHAVIORAL', 'description': 'exercises for back pain', 'armGroupLabels': ['2']}, {'name': 'Self-care book recommendations', 'type': 'BEHAVIORAL', 'description': 'Self-care book for back pain', 'armGroupLabels': ['3']}]}, 'contactsLocationsModule': {'locations': [{'zip': '98101', 'city': 'Seattle', 'state': 'Washington', 'country': 'United States', 'facility': 'Group Health Cooperative', 'geoPoint': {'lat': 47.60621, 'lon': -122.33207}}], 'overallOfficials': [{'name': 'Karen J. Sherman, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Kaiser Permanente'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Kaiser Permanente', 'class': 'OTHER'}, 'collaborators': [{'name': 'National Center for Complementary and Integrative Health (NCCIH)', 'class': 'NIH'}], 'responsibleParty': {'type': 'SPONSOR'}}}}