Ignite Creation Date:
2025-12-25 @ 1:26 AM
Ignite Modification Date:
2026-04-07 @ 8:37 PM
Study NCT ID:
NCT00165893
Status:
COMPLETED
Last Update Posted:
2013-12-24
First Post:
2005-09-09
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Comparison of IDD Therapy and Non-surgical Treatment for Low Back Pain Caused by Degenerative Disc Disease
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24', 'removedCountries': ['United States']}, 'conditionBrowseModule': {'meshes': [{'id': 'D055959', 'term': 'Intervertebral Disc Degeneration'}, {'id': 'D017116', 'term': 'Low Back Pain'}], 'ancestors': [{'id': 'D013122', 'term': 'Spinal Diseases'}, {'id': 'D001847', 'term': 'Bone Diseases'}, {'id': 'D009140', 'term': 'Musculoskeletal 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': 'D026741', 'term': 'Physical Therapy Modalities'}], 'ancestors': [{'id': 'D013812', 'term': 'Therapeutics'}, {'id': 'D012046', 'term': 'Rehabilitation'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE4'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'CROSSOVER'}, 'enrollmentInfo': {'count': 50}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2004-09'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2013-12', 'completionDateStruct': {'date': '2006-11', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2013-12-23', 'studyFirstSubmitDate': '2005-09-09', 'studyFirstSubmitQcDate': '2005-09-09', 'lastUpdatePostDateStruct': {'date': '2013-12-24', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2005-09-14', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2006-11', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Compare the changes in functional and pain scores in patients with chronic low back pain, which are alternatively treated with a standardized non-surgical treatment program.'}], 'secondaryOutcomes': [{'measure': 'Monitoring the side effects, medication use, total charges for treatment, need for continued care, work status, and patient satisfaction.'}]}, 'conditionsModule': {'keywords': ['low back pain', 'DDD'], 'conditions': ['Degenerative Disc Disease']}, 'referencesModule': {'seeAlsoLinks': [{'url': 'http://www.iddtherapy.com', 'label': "Manufacturer's web site with helpful information on IDD therapy."}]}, 'descriptionModule': {'briefSummary': 'This study is looking at a new machine called the Accu-Spina which administers internal disc decompression by following a computer program. This non-surgical treatment (similar to traction) is being compared to a rigorous physical therapy program.', 'detailedDescription': 'This study is a randomized trial where out of every 3 people, 2 will receive IDD therapy and 1 will have standardized physical therapy. Patients are given surveys to complete that ask about how their back pain is affecting their quality of life before starting treatment, 6 weeks after starting treatment, and 3, 6, and 12 months after starting treatment. If at the 6 week point, the patient and doctor do not think the current treatment is working well enough, the patient is given the option to try the other treatment.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': "Inclusion Criteria:\n\n* Chronic low back pain for \\> 3 months due to mild to moderate disc degeneration, lumbar spondylosis, and facet arthropathy without leg pain based on the physician's history and physical and imaging studies\n* Over 18 years old\n* Able to provide written informed consent\n\nExclusion Criteria:\n\n* Infection, neurological deficits, systemic disease that would affect treatment outcome such as inflammatory joint diseases; malignancies with involvement in the musculoskeletal system\n* Evidence of severe neural compression on imaging studies, i.e. spinal stenosis or large herniated disc\n* Uncontrolled mood disorder\n* History of drug or substance abuse\n* Lumbar spine pathology requiring surgical intervention\n* Previous spine surgery of the lumbar spine, except discectomies \\>12 months\n* Improvement with similar non-surgical treatments in the last 3 months\n* Active litigation, workers compensation\n* Females whom are pregnant"}, 'identificationModule': {'nctId': 'NCT00165893', 'briefTitle': 'Comparison of IDD Therapy and Non-surgical Treatment for Low Back Pain Caused by Degenerative Disc Disease', 'organization': {'class': 'OTHER', 'fullName': 'Emory University'}, 'officialTitle': 'Comparison of Internal Disc Decompression (IDD) vs. a Standardized Non-surgical Treatment Program for Chronic Low Back Pain Secondary to Mild to Moderate Degenerative Disc Disease (DDD)', 'orgStudyIdInfo': {'id': '0079-2004'}}, 'armsInterventionsModule': {'interventions': [{'name': 'Accu-Spina Device/IDD therapy', 'type': 'DEVICE'}, {'name': 'Physical Therapy', 'type': 'PROCEDURE'}]}, 'contactsLocationsModule': {'overallOfficials': [{'name': 'Michael K Schaufele, M.D.', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Emory University'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Emory University', 'class': 'OTHER'}, 'collaborators': [{'name': 'North American Medical Corporation', 'class': 'INDUSTRY'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Research Administrator', 'investigatorFullName': 'Kyle Webb', 'investigatorAffiliation': 'Emory University'}}}}