Ignite Creation Date:
2025-12-24 @ 3:38 PM
Ignite Modification Date:
2026-02-21 @ 6:41 AM
Study NCT ID:
NCT02552992
Status:
COMPLETED
Last Update Posted:
2019-11-19
First Post:
2015-08-18
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Yoga for Chronic Low Back Pain and Its Mechanism of Action: Impact of Strength and Stretch (YoMA II)
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'interventionBrowseModule': {'meshes': [{'id': 'D015013', 'term': 'Yoga'}], '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'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 22}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2015-01'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2019-11', 'completionDateStruct': {'date': '2016-12', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2019-11-18', 'studyFirstSubmitDate': '2015-08-18', 'studyFirstSubmitQcDate': '2015-09-15', 'lastUpdatePostDateStruct': {'date': '2019-11-19', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2015-09-17', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2015-10', 'type': 'ACTUAL'}}, 'outcomesModule': {'otherOutcomes': [{'measure': 'Change in Strength testing (Biodex Dynamometer)', 'timeFrame': '6 months'}, {'measure': 'Change in Trunk flexibility (sit-and-reach) testing', 'timeFrame': '6 months'}, {'measure': 'Change in Lateral flexion (goniometer) testing', 'timeFrame': '6 months'}, {'measure': 'Change in Pain Catastrophizing Scale', 'timeFrame': '6 months'}, {'measure': 'Change in Multidimensional Assessment of Interoceptive Awareness', 'timeFrame': '6 months'}], 'primaryOutcomes': [{'measure': 'Change in Roland Morris Disability Questionnaire', 'timeFrame': '6 months'}], 'secondaryOutcomes': [{'measure': 'Change in Numeric Rating Scale for Pain', 'timeFrame': '6 months'}, {'measure': 'Change in Pain Medication Usage Survey', 'timeFrame': '6 months'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'conditions': ['Chronic Low Back Pain']}, 'descriptionModule': {'briefSummary': "This study is a pilot, randomized controlled trial to provide feasibility and conduct preliminary analyses on physical (strength and stretch) mechanisms associated with a yoga intervention for non-specific chronic low back pain (cLBP). Recent large-scale trials have demonstrated the efficacy of a yoga intervention for cLBP however, many types of yoga classes are available to the public and a specialized yoga protocol for individuals with cLBP is needed. This study's goal is to quantify trunk strength and flexibility to better understand how these potential physical mechanisms specifically lead to improvement in pain-related outcomes including pain and disability. This knowledge will be used to design a large scale trial of mechanisms of yoga for cLBP. For this pilot study, 40 participants will be randomized to either a yoga intervention (N=20) or to a usual care group (N=20) that will receive The Back Pain Helpbook, a mind-body self-care program for better living. The yoga intervention will be offered weekly yoga classes and instructional materials will be provided for home practice."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '65 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Chronic low back pain lasting \\> 6 months\n* Back pain that is rated at least 3 on a numeric pain rating scale that ranges from 0 to 10 (0-no pain, 10 worst pain imaginable).\n* English language fluency\n\nExclusion Criteria:\n\n* BMI \\> 40\n* Inability to provide informed consent\n* Recent diagnosis of abdominal aneurism\n* Recent diagnosis of metastatic cancer\n* Recent diagnosis of discitis\n* Recent diagnosis of disk disease\n* Recent diagnosis of spinal stenosis\n* Recent diagnosis of spondylolisthesis\n* Recent diagnosis of infectious cause of back pain\n* Recent diagnosis of fracture of vertebra\n* Recent diagnosis of Fibromyalgia\n* Recent diagnosis of rheumatoid arthritis\n* Recent diagnosis of ankylosing spondylitis\n* Recent diagnosis of paralysis\n* Pregnancy\n* Prior or planned back surgery\n* Blindness or severe vision problems\n* Deafness or severe hearing problems\n* Bipolar or manic depression and not taking medication\n* Major depression\n* Psychoses (major)\n* a substance abuse condition\n* Dementia\n* Unable to get up and down from the floor\n* Involvement in a lawsuit related to back pain\n* Lack of transportation\n* Other disabling chronic conditions (e.g., disabling heart or lung disease, diabetic neuropathy, receiving treatment for hepatitis)\n* Currently (within the past 3 months) using yoga classes for more than 15 minutes per week\n* Inability to be contacted by phone or email\n* no computer access\n* schedule does not allow for participation in classes/home practice\n* planning to move out of town or take a long vacation during the period of the study'}, 'identificationModule': {'nctId': 'NCT02552992', 'briefTitle': 'Yoga for Chronic Low Back Pain and Its Mechanism of Action: Impact of Strength and Stretch (YoMA II)', 'organization': {'class': 'OTHER', 'fullName': 'University of California, San Francisco'}, 'officialTitle': 'Yoga for Chronic Low Back Pain and Its Mechanism of Action: Impact of Strength and Stretch (YoMA II)', 'orgStudyIdInfo': {'id': 'UCSFCHR14-14148'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Yoga Classes', 'description': 'Study Participants will receive: 12 weekly yoga classes, a book and a home practice audio recording.', 'interventionNames': ['Behavioral: Yoga']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Self-Directed Mind-Body Program', 'description': 'Study Participants will receive: The Back Pain Helpbook, a mind-body self-care program for better living.', 'interventionNames': ['Behavioral: Self-Directed Mind-Body Program']}], 'interventions': [{'name': 'Yoga', 'type': 'BEHAVIORAL', 'armGroupLabels': ['Yoga Classes']}, {'name': 'Self-Directed Mind-Body Program', 'type': 'BEHAVIORAL', 'armGroupLabels': ['Self-Directed Mind-Body Program']}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University of California, San Francisco', 'class': 'OTHER'}, 'collaborators': [{'name': 'Mount Zion Health Fund', 'class': 'OTHER'}], 'responsibleParty': {'type': 'SPONSOR'}}}}