Ignite Creation Date:
2025-12-24 @ 11:32 PM
Ignite Modification Date:
2026-02-23 @ 8:06 PM
Study NCT ID:
NCT02823756
Status:
COMPLETED
Last Update Posted:
2016-07-06
First Post:
2016-06-29
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Short-Term Effects of PT on Physical Activity
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D017116', 'term': 'Low Back Pain'}, {'id': 'D009043', 'term': 'Motor Activity'}, {'id': 'D059350', 'term': 'Chronic Pain'}], 'ancestors': [{'id': 'D001416', 'term': 'Back Pain'}, {'id': 'D010146', 'term': 'Pain'}, {'id': 'D009461', 'term': 'Neurologic Manifestations'}, {'id': 'D012816', 'term': 'Signs and Symptoms'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}, {'id': 'D001519', 'term': 'Behavior'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D026741', 'term': 'Physical Therapy Modalities'}], 'ancestors': [{'id': 'D013812', 'term': 'Therapeutics'}, {'id': 'D012046', 'term': 'Rehabilitation'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 27}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2015-03'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2016-06', 'completionDateStruct': {'date': '2016-04', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2016-06-30', 'studyFirstSubmitDate': '2016-06-29', 'studyFirstSubmitQcDate': '2016-06-30', 'lastUpdatePostDateStruct': {'date': '2016-07-06', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2016-07-06', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2016-04', 'type': 'ACTUAL'}}, 'outcomesModule': {'otherOutcomes': [{'measure': 'Visual Analog Scale', 'timeFrame': '1 day', 'description': 'A 10 cm horizontal line that the subject will use to descibe how intense their pain is before and after receiving a spinal manipulation by placing a vertical hash mark along the horizontal line to denote how intense his or her pain is.'}], 'primaryOutcomes': [{'measure': 'Change in Physical Activity Levels', 'timeFrame': '2 weeks', 'description': 'Accelerometer issued to subject at the initial data collection session and then data collected and downloaded one week later. Subject receives the intervention session, then is reissued the accelerometer. Subject returns the accelerometer one week after this intervention session with data that reflects physical activity levels that are after the intervention session'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'conditions': ['Low Back Pain', 'Motor Activity', 'Chronic Pain']}, 'referencesModule': {'references': [{'pmid': '29208007', 'type': 'DERIVED', 'citation': 'Brewer W, Swanson BT, Roddey TS, Adewale H, Ashmore C, Frerich J, Perrin C, Ortiz A. A pilot study to determine the effect of one physical therapy session on physical activity levels for individuals with chronic low back pain. BMC Res Notes. 2017 Dec 6;10(1):691. doi: 10.1186/s13104-017-3006-x.'}]}, 'descriptionModule': {'briefSummary': 'The primary purpose is to examine the impact that physical therapy (PT) interventions, including manipulations, have on physical activity levels outside of the clinical environment in persons with low back pain (LBP) as measured both objectively with an accelerometer and subjectively with questionnaires.\n\nThe secondary purpose is to determine if a relationship exists between objective physical activity, self-perceived disability pain catastrophizing thoughts, BMI, age, six-minute walk distance, lower extremity muscle endurance.\n\nThe tertiary purpose is to assess the predictive value that a standing manual lumbar unloading technique has for relief of pain following manipulation', 'detailedDescription': 'At session 1: Participants are screened for eligibility. Baseline outcome measures are conducted (self-report questionnaires and physical performance tests). Accelerometer which is an instrument to measure physical activity is issued.\n\nAt session 2 (To occur at least one-week later): Accelerometer data is retrieved and downloaded to a computer. Participant numerically rates low back pain level at rest and in most painful position. Participant receives a manual distraction procedure. Participant rates pain level again. Participant starts the physical therapy intervention (manipulation of the spine, muscular strengthening and cardiovascular exercise, education). Accelerometer is reissued again.\n\nAt session 3 (At least one-week later): Accelerometer is collected and data is retrieved. Participant continues with the intervention (manipulation, exercise, education).'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '70 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': "Inclusion Criteria:\n\n* 1\\. Patient referred to outpatient PT with a LBP related diagnosis\n\n 2\\. LBP without radiating pain distally to the knee \\> 3 months in duration\n\n 3\\. Ability to read and write in English or Spanish\n\n 4\\. Age between 18 and 70 years\n\n 5\\. Able to ambulate independently without assistive devices\n\n 6\\. Access to a computer or cell phone with an email address and/or the ability to receive short text messages\n\nExclusion Criteria:\n\n* 1\\. No previous diagnosis, radiological evidence, or clinical signs and symptoms of instability, spondylolysis, spondylolisthesis, fracture, tumor or metastases to the spine\n\n 2\\. No clinical indication of nerve root pathology such as: straight leg raise less than 45 degrees, asymmetric lower extremity deep tendon reflexes, lower extremity muscle strength deficits or radiating pain, numbness or tingling below the knee\n\n 3\\. No surgical or biological fusion to the spine\n\n 4\\. No previous spinal surgery\n\n 5\\. No known diagnosis of osteoporosis or rheumatoid arthritis\n\n 6\\. No use of oral steroids within the past 6 months\n\n 7\\. No epidural injection over the previous 4-weeks to the lumbar spine region\n\n 8\\. No current litigation, workman's compensation or disability claim for a low back injury\n\n 9\\. No known pregnancy"}, 'identificationModule': {'nctId': 'NCT02823756', 'briefTitle': 'Short-Term Effects of PT on Physical Activity', 'organization': {'class': 'OTHER', 'fullName': "Texas Woman's University"}, 'officialTitle': 'The Short-Term Effects of Manipulation and Physical Therapy on Physical Activity Levels', 'orgStudyIdInfo': {'id': '17852'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Physical Therapy', 'description': 'Treatment arm: manipulation, exercise, and education', 'interventionNames': ['Procedure: Physical Therapy']}], 'interventions': [{'name': 'Physical Therapy', 'type': 'PROCEDURE', 'description': 'Exercise, education, spinal manipulation', 'armGroupLabels': ['Physical Therapy']}]}, 'contactsLocationsModule': {'overallOfficials': [{'name': 'Wayne A Brewer, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': "Texas Woman's University"}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': "Texas Woman's University", 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Assistant Professor', 'investigatorFullName': 'Wayne Brewer', 'investigatorAffiliation': "Texas Woman's University"}}}}