Ignite Creation Date:
2025-12-25 @ 2:43 AM
Ignite Modification Date:
2026-04-18 @ 7:12 PM
Study NCT ID:
NCT02261233
Status:
TERMINATED
Last Update Posted:
2019-01-04
First Post:
2014-09-19
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Osteopathic Manipulative Treatment and Postural Control: Systems Engineering Approach
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D017116', 'term': 'Low Back 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'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D026301', 'term': 'Manipulation, Osteopathic'}], 'ancestors': [{'id': 'D026201', 'term': 'Musculoskeletal Manipulations'}, {'id': 'D000529', 'term': 'Complementary Therapies'}, {'id': 'D013812', 'term': 'Therapeutics'}, {'id': 'D026741', 'term': 'Physical Therapy Modalities'}, {'id': 'D012046', 'term': 'Rehabilitation'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'TRIPLE', 'whoMasked': ['CARE_PROVIDER', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'BASIC_SCIENCE', 'interventionModel': 'CROSSOVER'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 63}}, 'statusModule': {'whyStopped': 'Funding for this project ended as of August 31, 2018', 'overallStatus': 'TERMINATED', 'startDateStruct': {'date': '2014-04-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2019-01', 'completionDateStruct': {'date': '2018-08-31', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2019-01-02', 'studyFirstSubmitDate': '2014-09-19', 'studyFirstSubmitQcDate': '2014-10-09', 'lastUpdatePostDateStruct': {'date': '2019-01-04', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2014-10-10', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2018-08-31', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Change in postural control', 'timeFrame': 'Change from baseline to shortly after first treatment (1-2 days), from baseline to an expected average of week 4, and from week 4 to an expected average of week 8.', 'description': 'Postural control will be assessed in an unstable seated task, in which subjects will be asked to balance on a specially designed seat. The average deviations from the neutral seat position will be measured in degrees.'}, {'measure': 'Change in trunk muscle reflex latency', 'timeFrame': 'Change from baseline to shortly after first treatment (1-2 days), from baseline to an expected average of week 4, and from week 4 to an expected average of week 8.', 'description': 'Subjects will be pulling with their trunk on a cable held by an electromagnet. The electromagnet will be suddenly released. Trunk muscle response to sudden load release will be measured on electromyographical recordings in milliseconds.'}], 'secondaryOutcomes': [{'measure': 'Change in Patient Reported Outcomes Measurement Information System (PROMIS)', 'timeFrame': 'The expected average is weekly for this outcome measure until the end (expected average of 8 weeks).', 'description': 'Assesses weekly changes in physical function, anxiety, depression, fatigue, sleep, satisfaction with social role, and pain with PROMIS-29 questionnaire.'}, {'measure': 'Change in concomitant medication', 'timeFrame': 'The expected average is weekly for this outcome measure until the end (expected average of 8 weeks).tcome measure until the end, an expected average of 8 weeks.', 'description': 'Assesses weekly changes in the use of medication for treating low back pain, including the type of medication and the quantity of medication (i.e., number of pills) with a questionnaire.'}, {'measure': 'Change in Oswestry Disability Index', 'timeFrame': 'The expected average is weekly for this outcome measure until the end (expected average of 8 weeks).', 'description': 'Assesses weekly changes in functional activities related to low back disability with the Oswestry Disability Index questionnaire.'}, {'measure': 'Change in fear avoidance behavior', 'timeFrame': 'The expected average is weekly for this outcome measure until the end (expected average of 8 weeks).', 'description': 'Assesses weekly changes in fear avoidance behavior using the Fear Avoidance Beliefs questionnaire.'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'conditions': ['Low Back Pain']}, 'referencesModule': {'references': [{'pmid': '11295888', 'type': 'BACKGROUND', 'citation': 'Radebold A, Cholewicki J, Polzhofer GK, Greene HS. Impaired postural control of the lumbar spine is associated with delayed muscle response times in patients with chronic idiopathic low back pain. Spine (Phila Pa 1976). 2001 Apr 1;26(7):724-30. doi: 10.1097/00007632-200104010-00004.'}], 'seeAlsoLinks': [{'url': 'http://orthopedicresearch.msu.edu/', 'label': 'Website for Michigan State University Center for Orthopedic Research'}, {'url': 'http://nccam.nih.gov/', 'label': 'Website for the National Center for Complementary and Alternative Medicine (Sponsor)'}]}, 'descriptionModule': {'briefSummary': 'The overall goal of this project is to develop sensitive and objective clinical research tools for the assessment of postural control of the trunk. In order to accomplish this goal, we aim to quantify balance performance in an unstable seated task. Specifically, the investigators will quantify balance performance in low back pain participants before and after osteopathic manipulative treatment. The investigators hypothesize that there will be a significant improvement in balance performance after a single session of osteopathic manipulative treatment as well as after 4 sessions of osteopathic manipulative treatment and this improvement will be greater than any learning effect.\n\nA secondary objective of this study is to quantify differences in patient-oriented outcome measures (e.g., self-reported pain, disability) in low back pain participants before and after osteopathic manipulative treatment. The investigators hypothesize that there will be a significant improvement in these self-reported outcomes following osteopathic manipulative treatment. The association between improvement in postural control parameters and patient-oriented measures will also be explored.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '65 Years', 'minimumAge': '21 Years', 'healthyVolunteers': False, 'eligibilityCriteria': "Inclusion Criteria:\n\nAll participants must meet all of the inclusion criteria to participate in the study. Below is a list of inclusion criteria for LBP participants:\n\n* Age 21-65 years\n* Independently ambulatory\n* Able to speak and read English\n* Able to understand study procedures and to comply with them for the entire length of the study.\n* Willing to be randomized to either immediate or delayed treatment group.\n* Musculoskeletal pain - primarily in the low back region\n* Pain rating equal to or greater than 3 out of10 as indicated on the Numeric Rating Scale for Pain\n* Disability equal to or greater than 26% as indicated on the Oswestry Disability Questionnaire\n\nExclusion Criteria:\n\nAll candidates meeting any of the exclusion criteria at baseline will be excluded from study participation. Exclusion criteria will be self-reported. However, during each treatment session, the physicians will be watching for clinical signs and symptoms not consistent with physical findings that are suggestive of the presence of any of the exclusion criteria. In such a case, further treatment will be discontinued and the subject will be excluded.\n\nBelow is a list of exclusion criteria:\n\n* Inability or unwillingness of individual to give written informed consent.\n* Physical therapy or any other form of manual medicine (e.g., Osteopathic Manipulative Medicine, Chiropractic Manipulation, etc.), acupuncture or spinal injections within one month prior to study enrollment\n* Workers' compensation benefits in the past 3 months or ongoing medical legal issues\n* Possibly pregnant\n* Obesity (BMI\\>32)\n* Currently using electrical implants (e.g., cardiac pacemakers, drug delivery pumps, etc.)\n\nHistory of:\n\n* Spinal surgery\n* Spinal fracture\n* Spinal infection (e.g., osteomyelitis)\n* Cancer\n\nUnresolved symptoms from:\n\n* Head trauma\n* Inner ear infection with associated balance and coordination problems\n* Orthostatic hypotension\n* Uncontrolled hypertension\n* Vestibular disorder (e.g. vertigo)\n\nCurrent diagnosis of:\n\n* Significant spinal deformity (e.g., scoliosis \\> 20 degrees, torticollis)\n* Ankylosing spondylitis\n* Spondylolisthesis grades III or IV\n* Cauda equine syndrome\n* Rheumatoid arthritis\n* Osteoporosis\n* Angina or congestive heart failure symptoms\n* Active bleeding or infection in the back\n* Blindness\n* Seizures\n* Neurologic disease (e.g., Parkinson's disease, multiple sclerosis, cerebral palsy, Alzheimer's disease, amyotrophic lateral sclerosis, stroke or transient ischemic attack in the past year, cervical dystonia)\n\nConditions recognized by a physician any time during the study:\n\n* Significant or worsening signs of neurologic deficit\n* Symptoms are not consistent with mechanical findings\n* Other conditions impeding protocol implementation"}, 'identificationModule': {'nctId': 'NCT02261233', 'briefTitle': 'Osteopathic Manipulative Treatment and Postural Control: Systems Engineering Approach', 'organization': {'class': 'OTHER', 'fullName': 'Michigan State University'}, 'officialTitle': 'Osteopathic Manipulative Treatment and Postural Control: Systems Engineering Approach', 'orgStudyIdInfo': {'id': 'NCCAM U19 AT006057 Project 1'}, 'secondaryIdInfos': [{'id': '5U19AT006057-02', 'link': 'https://reporter.nih.gov/quickSearch/5U19AT006057-02', 'type': 'NIH'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Immediate treatment', 'description': 'This arm receives osteopathic manipulative treatment shortly after enrollment', 'interventionNames': ['Procedure: Osteopathic manipulative treatment']}, {'type': 'EXPERIMENTAL', 'label': 'Delayed treatment', 'description': 'This arm receives osteopathic manipulative treatment approximately 4 weeks after enrollment', 'interventionNames': ['Procedure: Osteopathic manipulative treatment']}], 'interventions': [{'name': 'Osteopathic manipulative treatment', 'type': 'PROCEDURE', 'description': 'Up to 4 sessions of osteopathic manipulative treatment (once per week)', 'armGroupLabels': ['Delayed treatment', 'Immediate treatment']}]}, 'contactsLocationsModule': {'locations': [{'zip': '48823', 'city': 'East Lansing', 'state': 'Michigan', 'country': 'United States', 'facility': 'MSU Osteopathic Manipulative Medicine', 'geoPoint': {'lat': 42.73698, 'lon': -84.48387}}, {'zip': '48891', 'city': 'Lansing', 'state': 'Michigan', 'country': 'United States', 'facility': 'MSU Musculoskeletal Rehabilitation', 'geoPoint': {'lat': 42.73253, 'lon': -84.55553}}, {'zip': '48910', 'city': 'Lansing', 'state': 'Michigan', 'country': 'United States', 'facility': 'Michigan State University Center for Orthopedic Research', 'geoPoint': {'lat': 42.73253, 'lon': -84.55553}}], 'overallOfficials': [{'name': 'Jacek Cholewicki, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Michigan State University'}, {'name': 'Norman P Reeves, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Michigan State University'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Michigan State University', 'class': 'OTHER'}, 'collaborators': [{'name': 'National Center for Complementary and Integrative Health (NCCIH)', 'class': 'NIH'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Walter F. Patenge Professor', 'investigatorFullName': 'Jacek Cholewicki', 'investigatorAffiliation': 'Michigan State University'}}}}