Ignite Creation Date:
2025-12-25 @ 3:30 AM
Ignite Modification Date:
2025-12-26 @ 2:11 AM
Study NCT ID:
NCT01145105
Status:
COMPLETED
Last Update Posted:
2011-11-10
First Post:
2010-05-24
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Neural Dynamics Technique for the Treatment of Chronic Radicular Low Back Pain
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D017116', 'term': 'Low Back Pain'}, {'id': 'D012585', 'term': 'Sciatica'}, {'id': 'D010146', 'term': 'Pain'}], 'ancestors': [{'id': 'D001416', 'term': 'Back Pain'}, {'id': 'D009461', 'term': 'Neurologic Manifestations'}, {'id': 'D012816', 'term': 'Signs and Symptoms'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}, {'id': 'D020426', 'term': 'Sciatic Neuropathy'}, {'id': 'D020422', 'term': 'Mononeuropathies'}, {'id': 'D010523', 'term': 'Peripheral Nervous System Diseases'}, {'id': 'D009468', 'term': 'Neuromuscular Diseases'}, {'id': 'D009422', 'term': 'Nervous System Diseases'}, {'id': 'D009437', 'term': 'Neuralgia'}]}, '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': 'QUADRUPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 34}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2010-06'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2011-07', 'completionDateStruct': {'date': '2011-07', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2011-11-09', 'studyFirstSubmitDate': '2010-05-24', 'studyFirstSubmitQcDate': '2010-06-15', 'lastUpdatePostDateStruct': {'date': '2011-11-10', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2010-06-16', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2011-07', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Efficacy of neural dynamics technique', 'timeFrame': '5 weeks', 'description': 'Efficacy will be measured by combining 5 tools\n\n1. Oswestry disability index.\n2. McGill Pain Questionnaire\n3. Visual analog scale for pain assessment.\n4. Lumbar flexion measurement (the distance of the tip of the index finger to the inferior angle of the Patella, measured by a measurement tape.\n5. Passive SLR range of motion- measured with inclinometer'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['Low back pain', 'Sciatica', 'Pain', 'Physiotherapy'], 'conditions': ['Low Back Pain', 'Sciatica']}, 'descriptionModule': {'briefSummary': 'Low back pain ( LBP) is a significant health problem which affects about 70%-80% of the population during the course of their life . The majority of LBP is resolved within 3 months; however, up to 40% of LBP becomes chronic. One subgroup of chronic LBP is patients with sciatica. Sciatica is characterized by radiating pain to the buttock and lower limb, with or without low back pain.\n\nIt has been shown in the upper limb that by positioning the contra-lateral arm in tension the investigators actually reduce tension in the ipsilateral arm. Patients, who present with symptoms like sciatica, can benefit from this maneuver (neural dynamics techniques) that reduces tension through the contra-lateral leg.\n\nWorking Hypothesis: Compared with a placebo maneuver of the upper limb, the neural dynamics techniques will result in better rehabilitation of individuals with radicular LBP.', 'detailedDescription': "Objectives: To evaluate the efficacy of neural dynamics techniques, using the contra-lateral leg, in the treatment of sub-acute/chronic Low back pain with radiation to the leg. Study Methodology: Eligible individuals will be assessed by a physiotherapist that will be blinded to the treatment allocation; treatment (either intervention or placebo) will be provided by a physiotherapist that will be blinded to the patient's assessment. The treated individuals and the referring physician will also be blinded to the treatment allocation;"}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '65 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Written consent\n* LBP with radiation to one leg, that lasts more than 6 weeks\n* Abnormal response to SLR test\n* With or without neurological signs\n\nExclusion Criteria:\n\n* History of spinal surgery\n* Patient with FUO\n* History of malignancies\n* Patient with saddle anesthesia'}, 'identificationModule': {'nctId': 'NCT01145105', 'briefTitle': 'Neural Dynamics Technique for the Treatment of Chronic Radicular Low Back Pain', 'organization': {'class': 'OTHER', 'fullName': 'Clalit Health Services'}, 'officialTitle': 'Efficacy of Neural Dynamics Technique in the Treatment of Chronic Low Back Pain With Radiation to the Leg', 'orgStudyIdInfo': {'id': 'K-09-0078-ctil'}}, 'armsInterventionsModule': {'interventions': [{'name': 'neural dynamics techniques treatment', 'type': 'PROCEDURE', 'otherNames': ['Physiotherapy'], 'description': 'Treatment group- will receive neural mobilizations techniques, to improve movement of the sciatic nerve.'}, {'name': 'placebo treatment', 'type': 'PROCEDURE', 'otherNames': ['physiotherapy'], 'description': 'Control group- will receive placebo treatment that will include mobilization to the upper limb. After the placebo treatment, these patients will receive neural mobilizations techniques.'}]}, 'contactsLocationsModule': {'locations': [{'city': 'Haifa', 'country': 'Israel', 'facility': 'Clalit Health Services, Haifa and Western Galilee District', 'geoPoint': {'lat': 32.81303, 'lon': 34.99928}}], 'overallOfficials': [{'name': 'Noga Roguin Maor, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'clinical research unit, Clalit health services, Haifa and western Galilee district.'}, {'name': 'Uzi Milman, MD', 'role': 'STUDY_DIRECTOR', 'affiliation': 'clinical research unit, Clalit health services, Haifa and western Galilee district.'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Clalit Health Services', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Uzi Milman MD, Clinical Research Unit, Clalit Health Services, Haifa District, HAIFA, ISRAEL.', 'investigatorFullName': 'Uzi Milman', 'investigatorAffiliation': 'Clalit Health Services'}}}}