Ignite Creation Date:
2025-12-24 @ 3:29 PM
Ignite Modification Date:
2025-12-25 @ 3:36 PM
Study NCT ID:
NCT01236092
Status:
TERMINATED
Last Update Posted:
2015-04-08
First Post:
2010-11-04
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Low Back Study to Compare Traditional Physical Therapy With Combined Therapy Protocol
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D011843', 'term': 'Radiculopathy'}, {'id': 'D017116', 'term': 'Low Back Pain'}], 'ancestors': [{'id': 'D010523', 'term': 'Peripheral Nervous System Diseases'}, {'id': 'D009468', 'term': 'Neuromuscular Diseases'}, {'id': 'D009422', 'term': 'Nervous System Diseases'}, {'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': 'D014732', 'term': 'Vibration'}, {'id': 'D015444', 'term': 'Exercise'}], 'ancestors': [{'id': 'D055595', 'term': 'Mechanical Phenomena'}, {'id': 'D055585', 'term': 'Physical Phenomena'}, {'id': 'D009043', 'term': 'Motor Activity'}, {'id': 'D009068', 'term': 'Movement'}, {'id': 'D009142', 'term': 'Musculoskeletal Physiological Phenomena'}, {'id': 'D055687', 'term': 'Musculoskeletal and Neural Physiological Phenomena'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 36}}, 'statusModule': {'whyStopped': 'Inadequate patient enrollment', 'overallStatus': 'TERMINATED', 'startDateStruct': {'date': '2011-04'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2012-07', 'completionDateStruct': {'date': '2013-12', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2015-04-07', 'studyFirstSubmitDate': '2010-11-04', 'studyFirstSubmitQcDate': '2010-11-05', 'lastUpdatePostDateStruct': {'date': '2015-04-08', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2010-11-08', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2013-06', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Radiographic changes in the low back', 'timeFrame': '6 months following enrollment', 'description': 'Anatomical measures will be done comparing pre-treatment versus post-treatment and will include foraminal dimensions, disc height, canal stenosis, lumbrosacral angle, and facet spacing.'}], 'secondaryOutcomes': [{'measure': 'determine the percentage of patients who do not obtain relief of symptoms from either therapy and move on to surgery and determine the statistical difference between therapies.', 'timeFrame': 'one year following initiation of therapy', 'description': 'The comparison of convervative therapies, the control group with standard physical therapy and the study group, serve as the comparitive for the success as measured by the number from each group which move to surgery within the one year.'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'keywords': ['resolution of low back pain', 'show measurable improvement in disc measurement', 'conservative therapy vs. surgery in resolving low back pain'], 'conditions': ['Radiculopathy', 'Low Back Pain']}, 'descriptionModule': {'briefSummary': 'The most common chronic low back pain conditions are a consequence of disc disease as well as muscular and bony etiologies. The discs degenerate and weaken, bulge and are pushed into the space containing the spinal cord or a nerve root resulting in severe pain. A common treatment is then surgery. Whole-body vibration combined with un-weighting traction and specific manual mobilization plus active therapeutic exercise seems to treat chronic low back pain by non-invasively firing muscles of the lumbar spine. The investigators are seeking to show such therapy reduces the need for surgery and significantly out performs traditional physical as the preferred conservative treatment.', 'detailedDescription': "Patients will be placed randomly in the control group and will receive 10 weeks of standard physical therapy or in the study group and receive an equivalent 10 weeks therapy utilizing vibration, unweighting, therapeutic exercise and manual mobilization. The study uses a baseline MRI and x-rays which have shown the justification for surgical intervention and during the course of the protocol will have repeat MRI's and x-rays to determine any statistical change in the lumbar spine resulting in reduction or elimination of pain, improved range of motion, improvements in performance and reduction or elimination for the need for surgical intervention. Anatomical measures will be done comparing pre-treatment versus post-treatment and will include foraminal dimensions,disc height, canal stenosis, lumbosacral angle and facet spacing. Questionnaires will be completed during the course of the treatment and post-treatment at 6 months and one year. The final follow up phone call to the patient will be made following 24 months post initial treatment to determine the current patient status pertaining to low back pain, subsequent treatment, surgery, etc. Final study documentation will occur at that time. Intermediate results at one year will compare the control group vs. the study group for overall result differences."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '65 Years', 'minimumAge': '25 Years', 'healthyVolunteers': False, 'eligibilityCriteria': "Inclusion Criteria:\n\n* MRI of the lumbar spine showing symptoms and severity to qualify for surgery\n* 25 to 65 years of age\n* Diagnosis of low back pain for 3-12 months\n* Potential surgical candidates but not mandatory\n\nExclusion Criteria:\n\n* any medical or physical conditions deemed unacceptable by the participants physician or health care provider\n* Evidence of progressive or debilitative medical conditions i.e. metastatic cancer, major stroke, crippling arthritis, unstable angina, orthostatic hypotension, hemiplegia, multiple sclerosis or Parkinson's disease.\n* Any condition that would preclude the additional burden of a repeat MRI or preclude active involvement in the protocol or physical therapy\n* Active use of tobacco products\n* Prior back surgery\n* Pregnancy"}, 'identificationModule': {'nctId': 'NCT01236092', 'briefTitle': 'Low Back Study to Compare Traditional Physical Therapy With Combined Therapy Protocol', 'organization': {'class': 'INDUSTRY', 'fullName': 'Michael Wilson & Associates Health Care Consulting, LLC'}, 'officialTitle': 'Clinical Study Comparing Traditional Physical Therapy and Alternate Therapy in Patients With Lumbar Radiculitis and Radiculopathy Secondary to Neural Compression.', 'orgStudyIdInfo': {'id': 'mwilson consulting, llc'}}, 'armsInterventionsModule': {'interventions': [{'name': 'conservative therapy - traction, vibration, exercise', 'type': 'OTHER', 'description': '10 weeks of therapy. 3 treatments per week the first 4 weeks and 2 treatments the final 6 weeks.'}]}, 'contactsLocationsModule': {'locations': [{'zip': '99204', 'city': 'Spokane', 'state': 'Washington', 'country': 'United States', 'facility': "St. Luke's Rhabilitation Institute and Revita Back", 'geoPoint': {'lat': 47.65966, 'lon': -117.42908}}], 'overallOfficials': [{'name': 'Dean Martz, m.d.', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Inland Neurosurgery and Spine'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Michael Wilson & Associates Health Care Consulting, LLC', 'class': 'INDUSTRY'}, 'collaborators': [{'name': 'Pneumex Corporation', 'class': 'OTHER'}], 'responsibleParty': {'type': 'SPONSOR'}}}}