Ignite Creation Date:
2025-12-24 @ 1:12 PM
Ignite Modification Date:
2026-01-03 @ 6:48 PM
Study NCT ID:
NCT01402895
Status:
COMPLETED
Last Update Posted:
2012-02-08
First Post:
2011-07-22
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
The Effect Of A Neurodynamic Treatment On Nerve Conduction In Clients With Low Back Pain
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': 'D015444', 'term': 'Exercise'}], 'ancestors': [{'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': 'TRIPLE', 'whoMasked': ['PARTICIPANT', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 9}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2011-05'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2011-07', 'completionDateStruct': {'date': '2011-10', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2012-02-07', 'studyFirstSubmitDate': '2011-07-22', 'studyFirstSubmitQcDate': '2011-07-25', 'lastUpdatePostDateStruct': {'date': '2012-02-08', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2011-07-26', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2011-10', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Change in nerve conduction studies', 'timeFrame': 'Change from baseline after intervention, on average 1.5 hours after baseline measure', 'description': 'Motor conduction of the tibial nerve; Sensory conduction of the sural nerve; H-reflex, H:M ratio (soleus muscle)'}], 'secondaryOutcomes': [{'measure': 'Change of knee extension in sitting slump test', 'timeFrame': 'Change from baseline after intervention, on average 1.5 hours after baseline measure'}, {'measure': 'Change in score of Visual Analog Scale for pain', 'timeFrame': 'Change from baseline after intervention, on average 1.5 hours after baseline measure'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['Nerve conduction', 'H-reflex, mobilizations', 'with neurodynamic component'], 'conditions': ['Low Back Pain']}, 'referencesModule': {'references': [{'pmid': '157532', 'type': 'BACKGROUND', 'citation': 'Breig A, Troup JD. Biomechanical considerations in the straight-leg-raising test. Cadaveric and clinical studies of the effects of medial hip rotation. Spine (Phila Pa 1976). 1979 May-Jun;4(3):242-50. doi: 10.1097/00007632-197905000-00011.'}, {'type': 'BACKGROUND', 'citation': 'Butler, D.S. (1991). SLR, The Slump Test in Mobilisation of the Nervous System (pp.130-135, 139-146). London (UK): Elsevier Limited.'}, {'pmid': '20784219', 'type': 'BACKGROUND', 'citation': 'Cyriax J. Perineuritis. Br Med J. 1942 May 9;1(4244):578-80. doi: 10.1136/bmj.1.4244.578. No abstract available.'}, {'pmid': '16595445', 'type': 'BACKGROUND', 'citation': 'DeLeo JA. Basic science of pain. J Bone Joint Surg Am. 2006 Apr;88 Suppl 2:58-62. doi: 10.2106/JBJS.E.01286.'}, {'pmid': '6883862', 'type': 'BACKGROUND', 'citation': 'Gelberman RH, Szabo RM, Williamson RV, Hargens AR, Yaru NC, Minteer-Convery MA. Tissue pressure threshold for peripheral nerve viability. Clin Orthop Relat Res. 1983 Sep;(178):285-91.'}, {'type': 'BACKGROUND', 'citation': 'Kimura, J. (1983). Tibial nerve, Sural nerve, The H-reflex and other late responses., Electrodiagnosis in Diseases of Nerve and Muscle: Principles and Practice. (pp. 125-127, 130-134, 379-385). U.S.A.: F. A. Davis Company.'}, {'pmid': '4707307', 'type': 'BACKGROUND', 'citation': 'Lundborg G, Rydevik B. Effects of stretching the tibial nerve of the rabbit. A preliminary study of the intraneural circulation and the barrier function of the perineurium. J Bone Joint Surg Br. 1973 May;55(2):390-401. No abstract available.'}, {'pmid': '16791369', 'type': 'BACKGROUND', 'citation': 'Mahmud MA, Merlo AR, Gomes I, Becker J, Nora DB. [Relationship between adverse neural tension and nerve conduction studies in patients with symptoms of the carpal tunnel syndrome]. Arq Neuropsiquiatr. 2006 Jun;64(2A):277-82. doi: 10.1590/s0004-282x2006000200019. Epub 2006 Jun 9. Portuguese.'}, {'pmid': '25026403', 'type': 'BACKGROUND', 'citation': 'Maitland GD. Negative disc exploration: positive canal signs. Aust J Physiother. 1979 Jul;25(3):129-34. doi: 10.1016/S0004-9514(14)61220-4.'}, {'pmid': '7594983', 'type': 'BACKGROUND', 'citation': 'Nakamichi K, Tachibana S. Restricted motion of the median nerve in carpal tunnel syndrome. J Hand Surg Br. 1995 Aug;20(4):460-4. doi: 10.1016/s0266-7681(05)80153-6.'}, {'pmid': '3958526', 'type': 'BACKGROUND', 'citation': 'Ogata K, Naito M. Blood flow of peripheral nerve effects of dissection, stretching and compression. J Hand Surg Br. 1986 Feb;11(1):10-4. doi: 10.1016/0266-7681(86)90003-3.'}, {'pmid': '9038924', 'type': 'BACKGROUND', 'citation': 'Schaafsma L, Sun H, Zochodne D. Exogenous opioids influence the microcirculation of injured peripheral nerves. Am J Physiol. 1997 Jan;272(1 Pt 2):H76-82. doi: 10.1152/ajpheart.1997.272.1.H76.'}, {'type': 'BACKGROUND', 'citation': 'Shacklock, M. (1995). Neurodynamics. Physiotherapy, 81, 9-16.'}, {'type': 'BACKGROUND', 'citation': 'Shacklock, M. (2005a). Clinical neurodynamics: A new system of musculoskeletal treatment (pp. 2-29, 98-104, 154-158). London (UK): Elsevier Butterworth Heinemann.'}, {'pmid': '16038853', 'type': 'BACKGROUND', 'citation': 'Shacklock M. Improving application of neurodynamic (neural tension) testing and treatments: a message to researchers and clinicians. Man Ther. 2005 Aug;10(3):175-9. doi: 10.1016/j.math.2005.03.001. Epub 2005 Apr 20. No abstract available.'}, {'pmid': '15128188', 'type': 'BACKGROUND', 'citation': 'Spadoni GF, Stratford PW, Solomon PE, Wishart LR. The evaluation of change in pain intensity: a comparison of the P4 and single-item numeric pain rating scales. J Orthop Sports Phys Ther. 2004 Apr;34(4):187-93. doi: 10.2519/jospt.2004.34.4.187.'}, {'pmid': '15375820', 'type': 'BACKGROUND', 'citation': 'Stretanski MF. H-reflex latency and nerve root tension sign correlation in fluoroscopically guided, contrast-confirmed, translaminar lumbar epidural steroid-bupivacaine injections. Arch Phys Med Rehabil. 2004 Sep;85(9):1479-82. doi: 10.1016/j.apmr.2003.09.024.'}, {'pmid': '14784487', 'type': 'BACKGROUND', 'citation': 'WOODHALL B, HAYES GJ. The well-legraising test of Fajersztajn in the diagnosis of ruptured lumbar intervertebral disc. J Bone Joint Surg Am. 1950 Oct;32 A(4):786-92. No abstract available.'}, {'pmid': '1855142', 'type': 'BACKGROUND', 'citation': 'Zochodne DW, Ho LT. Stimulation-induced peripheral nerve hyperemia: mediation by fibers innervating vasa nervorum? Brain Res. 1991 Apr 12;546(1):113-8. doi: 10.1016/0006-8993(91)91165-w.'}, {'pmid': '2397398', 'type': 'BACKGROUND', 'citation': 'Zochodne DW, Huang ZX, Ward KK, Low PA. Guanethidine-induced adrenergic sympathectomy augments endoneurial perfusion and lowers endoneurial microvascular resistance. Brain Res. 1990 Jun 11;519(1-2):112-7. doi: 10.1016/0006-8993(90)90067-l.'}, {'pmid': '2285433', 'type': 'BACKGROUND', 'citation': 'Zochodne DW, Low PA. Adrenergic control of nerve blood flow. Exp Neurol. 1990 Sep;109(3):300-7. doi: 10.1016/s0014-4886(05)80021-4.'}]}, 'descriptionModule': {'briefSummary': 'The purpose of this study is to determine if a certain treatment for low back pain can change the way nerves in the leg send messages. Specifically, the investigators will examine whether a particular type of physical therapy treatment for individuals with low back pain (neurodynamic techniques) changes the speed that nerves send/receive signals to/from the leg, as compared to a different physical therapy treatment.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Males and females aged 18 years and older\n* Participants who can speak English and read, understand, and fill out the consent form and questionnaires\n* Participants will have a certain level of low back pain graded numerically, with or without radiation to the leg\n* Clinical decision (by same individual) as safe to participate in study based on subjective history and objective examination.\n\nExclusion Criteria:\n\n* An inability to tolerate sitting for 10 minutes\n* Nerve conduction disorders diagnosed by a physician such as, diabetes or MS\n* Current participant in an investigational drug study (within past 3 months)'}, 'identificationModule': {'nctId': 'NCT01402895', 'briefTitle': 'The Effect Of A Neurodynamic Treatment On Nerve Conduction In Clients With Low Back Pain', 'organization': {'class': 'OTHER', 'fullName': 'McMaster University'}, 'officialTitle': 'The Effect Of A Neurodynamic Treatment On Nerve Conduction In Clients With Low Back Pain', 'orgStudyIdInfo': {'id': '10-541'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'Mobilizations', 'description': 'The physiotherapist will perform mobilizations to the L-spine and SI joints with the participant in a specific position.', 'interventionNames': ['Other: Mobilizations']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Exercise', 'description': 'The physiotherapist will teach the participant how to tighten the transversus abdominus muscle. The participant will be asked to do a series of these exercises.', 'interventionNames': ['Other: Exercise']}], 'interventions': [{'name': 'Exercise', 'type': 'OTHER', 'description': 'Transversus abdominus exercise', 'armGroupLabels': ['Exercise']}, {'name': 'Mobilizations', 'type': 'OTHER', 'description': 'The physiotherapist will perform mobilizations to the L-spine and SI joints with the participant in a specific position.', 'armGroupLabels': ['Mobilizations']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Hamilton', 'state': 'Ontario', 'country': 'Canada', 'facility': 'McMaster University', 'geoPoint': {'lat': 43.25011, 'lon': -79.84963}}], 'overallOfficials': [{'name': 'Victoria Galea, PhD', 'role': 'STUDY_DIRECTOR', 'affiliation': 'McMaster University'}, {'name': 'Joy MacDermid, PhD', 'role': 'STUDY_CHAIR', 'affiliation': 'McMaster University'}, {'name': 'Linda Woodhouse, PhD', 'role': 'STUDY_CHAIR', 'affiliation': 'University of Alberta'}, {'name': 'Anita Gross, MSc', 'role': 'STUDY_CHAIR', 'affiliation': 'McMaster University'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'McMaster University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}