Ignite Creation Date:
2025-12-24 @ 11:03 PM
Ignite Modification Date:
2025-12-25 @ 8:34 PM
Study NCT ID:
NCT03432169
Status:
COMPLETED
Last Update Posted:
2019-10-10
First Post:
2018-02-01
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Yoga vs Stretching in Veterans With Chronic Lower Back Pain: Does Mindfulness Matter?
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'interventionBrowseModule': {'meshes': [{'id': 'D015013', 'term': 'Yoga'}, {'id': 'D064866', 'term': 'Mindfulness'}], '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': 'D015928', 'term': 'Cognitive Behavioral Therapy'}, {'id': 'D001521', 'term': 'Behavior Therapy'}, {'id': 'D011613', 'term': 'Psychotherapy'}, {'id': 'D004191', 'term': 'Behavioral Disciplines and Activities'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['OUTCOMES_ASSESSOR'], 'maskingDescription': 'Will code data entered into database.'}, 'primaryPurpose': 'OTHER', 'interventionModel': 'PARALLEL', 'interventionModelDescription': 'Group A receives Yoga (stretching with mindfulness) and Group B receives stretching (stretching without mindfulness)'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 20}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2018-02-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2019-10', 'completionDateStruct': {'date': '2018-12-31', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2019-10-09', 'studyFirstSubmitDate': '2018-02-01', 'studyFirstSubmitQcDate': '2018-02-07', 'lastUpdatePostDateStruct': {'date': '2019-10-10', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2018-02-14', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2018-06-30', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Feasibility', 'timeFrame': '6 months', 'description': 'The main purpose of the study is to assess feasibility of conducting a larger trial. The study team will assess number of Veterans recruited and enrolled in the study. Number of sessions completed.'}], 'secondaryOutcomes': [{'measure': 'PROMIS Global Health Scale (GHS):', 'timeFrame': 'baseline, immediately post intervention', 'description': 'Patient reported outcome measurement information system has developed a quality of life tool that provides an overall index score for quality of life. This form has recently been validated in comparison to the EuroQual. T-Score distributions are standardized such that a 50 represents the average (mean) for the US general population, and the standard deviation around that mean is 10 points. A high score always represents more of the concept being measured.'}, {'measure': 'Pain, Engagement and General activity (PEG)', 'timeFrame': 'baseline, immediately post intervention', 'description': 'An ultra-brief three-item scale derived from the Brief Pain Inventory (BPI), was a reliable and valid measure of pain among primary care patients with chronic musculoskeletal pain and diverse VA ambulatory patients.'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Chronic Low Back Pain']}, 'descriptionModule': {'briefSummary': 'The purpose of this study is to demonstrate the feasibility of recruiting, enrolling and collecting outcome data on CLBP patients within the Veterans Affairs Community Based Rochester Outpatient Center who undergo an 8 week active exercise class with mindfulness (yoga) and without mindfulness (stretching class)', 'detailedDescription': 'The study will approach all new or existing patients within the chiropractic clinic between the ages of 18 and 89 who have low back pain greater than 12 weeks and pain greater than or equal to 3, who have no contraindications to active exercise. Patients will be queried as to interest and those interested will be consented. The investigators will recruit a total of 20 patients. Patients will then be randomized to receive either an 8 week active exercise class with mindfulness (yoga) or an 8 week active exercise class without mindfulness (stretching class). Both groups will have home exercise requirements and will be held accountable through the use of a home practice log. Outcomes will include: Pain (PEG), Quality of Life (PROMIS Global Health Survey GHS), Self Efficacy (2 Question), Fear Avoidance Belief, Castrophizing and Social Engagement. Outcomes will be collected at baseline, and again at the end of the 8 week intervention. Clinician open ended questionnaire will be given to both study clinicians at the end of the trial.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '89 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Adult Veterans between the ages of 18-89\n* Lower back pain \\> 12 weeks\n* Have the ability to exercise independently.\n\nExclusion Criteria:\n\n* Subjects will be excluded if\n* They are currently enrolled in or maintain a home meditation practice\n* If they are currently involved in a mindfulness or cognitive behavioral therapy group.\n* If they have participated in a structured group yoga class in the last three months.\n* If they have an open workers compensation or no-fault case or have undergone spinal surgery in the past 6 months.'}, 'identificationModule': {'nctId': 'NCT03432169', 'briefTitle': 'Yoga vs Stretching in Veterans With Chronic Lower Back Pain: Does Mindfulness Matter?', 'organization': {'class': 'FED', 'fullName': 'Canandaigua VA Medical Center'}, 'officialTitle': 'Yoga vs Stretching in Veterans With Chronic Lower Back Pain: Does Mindfulness Matter?', 'orgStudyIdInfo': {'id': 'IRBnet 1135250'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'Yoga', 'description': 'Stretching with mindfulness', 'interventionNames': ['Other: Yoga (stretching plus mindfulness)']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Stretching', 'description': 'Stretching exercises without mindfulness', 'interventionNames': ['Other: Stretching']}], 'interventions': [{'name': 'Yoga (stretching plus mindfulness)', 'type': 'OTHER', 'description': 'Stretching plus mindfulness', 'armGroupLabels': ['Yoga']}, {'name': 'Stretching', 'type': 'OTHER', 'description': 'Stretching alone', 'armGroupLabels': ['Stretching']}]}, 'contactsLocationsModule': {'locations': [{'zip': '14620', 'city': 'Rochester', 'state': 'New York', 'country': 'United States', 'facility': 'Rochester Outpatient Clinic (ROPC) of the Canandaigua VA Medical Center', 'geoPoint': {'lat': 43.15478, 'lon': -77.61556}}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Canandaigua VA Medical Center', 'class': 'FED'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Staff Chiropractor', 'investigatorFullName': 'Paul Dougherty, DC', 'investigatorAffiliation': 'Canandaigua VA Medical Center'}}}}