Ignite Creation Date:
2025-12-24 @ 10:52 PM
Ignite Modification Date:
2026-01-22 @ 12:15 AM
Study NCT ID:
NCT03863769
Status:
COMPLETED
Last Update Posted:
2022-01-14
First Post:
2019-02-14
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Chiropractic Distraction Spinal Manipulation- Lumbar Stenosis Study
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'OTHER', 'observationalModel': 'OTHER'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 14}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2019-03-14', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2021-12', 'completionDateStruct': {'date': '2020-12-31', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2021-12-28', 'studyFirstSubmitDate': '2019-02-14', 'studyFirstSubmitQcDate': '2019-03-04', 'lastUpdatePostDateStruct': {'date': '2022-01-14', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2019-03-05', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2020-05-30', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Balance tracking', 'timeFrame': 'Each participant will be tested for one minute', 'description': 'The primary outcome is static balance as assessed by center of pressure (COP) using a portable force plate (Balance Tracking Systems, BTrackS™).'}], 'secondaryOutcomes': [{'measure': 'Questionnaire: Pain sclae', 'timeFrame': '5 Minutes', 'description': 'Pain severity of the lower back and buttock using a numerical rating scale (0-10)'}, {'measure': 'Questionnaire: Disability', 'timeFrame': '5 Minutes', 'description': 'Stenosis specific disability using the Zurich Claudication Questionnaire; symptom and function. Zurich Claudication Questionnaire has a 7-item symptom severity subscale with scores from 1 to 5 and a 5-item physical function subscale with scores from 1 to 4. The total score range is 12 to 55 points, with higher scores indicating higher levels of self-reported disability.'}, {'measure': 'Questionnaire: Balance', 'timeFrame': '5 Minutes', 'description': 'Balance Specific Confidence (ABC-6)'}, {'measure': 'Questionnaire: Change', 'timeFrame': '5 Minutes', 'description': 'Patient Global Impression of Change, this 1-item question has a 7-point rating scale with 1 being no change and 7 being considerable improvement.'}, {'measure': 'Sit to Stand', 'timeFrame': '5 Minutes', 'description': 'physical performance as assessed by the 5 Times Sit to Stand and Timed Up and Go tests.'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False}, 'conditionsModule': {'keywords': ['Chiropractic manipulation', 'postural sway', 'distraction manipulation', 'performance-based mobility'], 'conditions': ['Spinal Stenosis Lumbar']}, 'descriptionModule': {'briefSummary': 'To assess the effect of chiropractic distraction manipulation on postural sway and simple measures of performance in patients with the clinical diagnosis of lumbar spinal stenosis.', 'detailedDescription': 'This study aims to assess the effect of chiropractic distraction manipulation in reducing postural sway and improving performance-based mobility and disability in patients with the clinical diagnosis of lumbar spinal stenosis. This study will identify if distraction spinal manipulation will reduce postural sway center of pressure (COP) movements as determined by a force plate, if distraction spinal manipulation will improve simple measures of performance-based mobility and if distraction spinal manipulation will improve perception of balance confidence and will reduce self-rated stenosis associated disability.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '48 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': "The population studied will be existing and/or new patients at the Cox Certified Doctor's private practice.", 'healthyVolunteers': True, 'eligibilityCriteria': "Inclusion Criteria:\n\n* Age greater than 48 years old\n* Patient has leg or buttock pain while walking\n* Patient feels relief of symptoms with bending (flexing) forward\n* Patient feels relief when using a shopping cart of bicycle\n* Patient has motor or sensory disturbance while walking\n* Patient has normal and symmetrical foot pulses\n* Patient has lower extremity weakness\n* Patient has low back pain\n* Duration of symptoms and signs for more than 1 month\n* Able to stand and walk without assistive devices for at least 20 minutes\n* Able to give written informed consent and complete interviews and questionnaires in English\n\nExclusion Criteria:\n\n* Complicated spinal pain due to fracture, tumor, infection, or severe spondyloarthropathy\n* Has other severe co-morbidities, including progressive neurological deficit\n* Other serious pathologies of the locomotor system\n* No correspondence availability through email\n* Inability to read/ comprehend English\n* Compensation or seeking compensation from a third-party liability or workers' compensation\n* Previous spinal manipulation within the past month"}, 'identificationModule': {'nctId': 'NCT03863769', 'acronym': 'Stenosis', 'briefTitle': 'Chiropractic Distraction Spinal Manipulation- Lumbar Stenosis Study', 'organization': {'class': 'OTHER', 'fullName': 'Parker University'}, 'officialTitle': 'The Influence of Chiropractic Distraction Spinal Manipulation on Posture and Performance in Patients With Lumbar Spinal Stenosis.', 'orgStudyIdInfo': {'id': 'Parker19_02'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Lumbar Spinal Stenosis', 'description': 'Questionnaire, chiropractic treatment, and posture and performance testing.', 'interventionNames': ['Other: Lumbar Spinal Stenosis']}], 'interventions': [{'name': 'Lumbar Spinal Stenosis', 'type': 'OTHER', 'description': 'Posture and Performance testing: ABC-6 Scale, low back pain NRS, buttock or leg pain NRS, five times sit-to-stand, timed up-and-go, PGIC, eyes open force plate assessment (30 seconds), and eyes closed force plate assessment (30 seconds).', 'armGroupLabels': ['Lumbar Spinal Stenosis']}]}, 'contactsLocationsModule': {'locations': [{'zip': '75229', 'city': 'Dallas', 'state': 'Texas', 'country': 'United States', 'facility': 'Parker University', 'geoPoint': {'lat': 32.78306, 'lon': -96.80667}}], 'overallOfficials': [{'name': 'Katie Pohlman, DC, MS, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Parker University'}]}, 'ipdSharingStatementModule': {'infoTypes': ['STUDY_PROTOCOL', 'ICF', 'CSR'], 'ipdSharing': 'YES', 'description': 'Information about this study and individual data will be made available per request and approval from all investigator members.'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Parker University', 'class': 'OTHER'}, 'collaborators': [{'name': 'University of Houston', 'class': 'OTHER'}, {'name': 'Whittier College', 'class': 'UNKNOWN'}, {'name': 'Private Practice', 'class': 'UNKNOWN'}, {'name': 'Miami University', 'class': 'OTHER'}], 'responsibleParty': {'type': 'SPONSOR'}}}}