Ignite Creation Date:
2025-12-24 @ 9:08 PM
Ignite Modification Date:
2026-03-04 @ 10:25 PM
Study NCT ID:
NCT03135704
Status:
UNKNOWN
Last Update Posted:
2017-05-08
First Post:
2017-04-20
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Comparison of Two Treatments for Low Back Pain: "Re Spine" vs. Physiotherapy
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': 'D026741', 'term': 'Physical Therapy Modalities'}], 'ancestors': [{'id': 'D013812', 'term': 'Therapeutics'}, {'id': 'D012046', 'term': 'Rehabilitation'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 60}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'NOT_YET_RECRUITING', 'startDateStruct': {'date': '2017-05', 'type': 'ESTIMATED'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2017-05', 'completionDateStruct': {'date': '2019-01', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2017-05-03', 'studyFirstSubmitDate': '2017-04-20', 'studyFirstSubmitQcDate': '2017-04-26', 'lastUpdatePostDateStruct': {'date': '2017-05-08', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2017-05-01', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2019-01', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Reduction in low back pain', 'timeFrame': '1 day, 6 weeks, 3 months', 'description': 'Pain levels will be measured using the Visual Analogue Scale (VAS) on the first day of study and 6 weeks, and 3 months after treatment at end of study.'}, {'measure': 'Effectiveness of treatment', 'timeFrame': '1 day, 6 weeks, 3 months', 'description': 'Effectiveness of treatment will be assessed based on Oswestry Disability Index and Mini Sleep Questionnaire on the first day of study and 6 weeks, and 3 months after treatment at end of study.'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Low Back Pain']}, 'descriptionModule': {'briefSummary': 'The objective of this study is to assess the effectiveness of the "Re Spine" mattress, which was designed as an alternative to physiotherapy in the treatment of low back pain (LBP).'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '75 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Low back pain\n\nExclusion Criteria:\n\n* None'}, 'identificationModule': {'nctId': 'NCT03135704', 'briefTitle': 'Comparison of Two Treatments for Low Back Pain: "Re Spine" vs. Physiotherapy', 'organization': {'class': 'OTHER_GOV', 'fullName': 'Hillel Yaffe Medical Center'}, 'officialTitle': 'Comparison of Two Treatments for Low Back Pain: "Re Spine" vs. Physiotherapy', 'orgStudyIdInfo': {'id': 'HYMC-0025-17'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': '"Re Spine" Mattress', 'description': 'Adults suffering low back pain will treat their low back pain using the "Re Spine" mattress', 'interventionNames': ['Device: "Re Spine"']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Physiotherapy', 'description': 'Adults suffering low back pain will treat their low back pain using conventional physiotherapy protocols', 'interventionNames': ['Other: Physiotherapy']}], 'interventions': [{'name': '"Re Spine"', 'type': 'DEVICE', 'description': 'A new mattress design made of special materials and built in a specially shaped structure that allows the brain to relax the body and dissipate tension accumulated on the lumbar spine.', 'armGroupLabels': ['"Re Spine" Mattress']}, {'name': 'Physiotherapy', 'type': 'OTHER', 'description': 'Usual protocol for treatment of low back pain', 'armGroupLabels': ['Physiotherapy']}]}, 'contactsLocationsModule': {'locations': [{'zip': '38100', 'city': 'Hadera', 'country': 'Israel', 'contacts': [{'name': 'Ilana Alony, RN', 'role': 'CONTACT', 'email': 'ilanaa@hy.health.gov.il', 'phone': '972-52-3747719'}], 'facility': 'Hillel Yaffe Medical Center', 'geoPoint': {'lat': 32.44192, 'lon': 34.9039}}], 'centralContacts': [{'name': 'Eyal Behrbelk, Dr', 'role': 'CONTACT', 'email': 'EyalB@hy.health.gov.il', 'phone': '972-58-4747052'}], 'overallOfficials': [{'name': 'Eyal Behrbalk, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Hillel Yaffe Medical Center'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Hillel Yaffe Medical Center', 'class': 'OTHER_GOV'}, 'responsibleParty': {'type': 'SPONSOR'}}}}