- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01402895
The Effect Of A Neurodynamic Treatment On Nerve Conduction In Clients With Low Back Pain
February 7, 2012 updated by: McMaster University
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.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Study Type
Interventional
Enrollment (Actual)
9
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
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Ontario
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Hamilton, Ontario, Canada
- McMaster University
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-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years and older (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
Inclusion Criteria:
- Males and females aged 18 years and older
- Participants who can speak English and read, understand, and fill out the consent form and questionnaires
- Participants will have a certain level of low back pain graded numerically, with or without radiation to the leg
- Clinical decision (by same individual) as safe to participate in study based on subjective history and objective examination.
Exclusion Criteria:
- An inability to tolerate sitting for 10 minutes
- Nerve conduction disorders diagnosed by a physician such as, diabetes or MS
- Current participant in an investigational drug study (within past 3 months)
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Triple
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Active Comparator: Mobilizations
The physiotherapist will perform mobilizations to the L-spine and SI joints with the participant in a specific position.
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The physiotherapist will perform mobilizations to the L-spine and SI joints with the participant in a specific position.
|
Active Comparator: Exercise
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.
|
Transversus abdominus exercise
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Change in nerve conduction studies
Time Frame: Change from baseline after intervention, on average 1.5 hours after baseline measure
|
Motor conduction of the tibial nerve; Sensory conduction of the sural nerve; H-reflex, H:M ratio (soleus muscle)
|
Change from baseline after intervention, on average 1.5 hours after baseline measure
|
Secondary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Change of knee extension in sitting slump test
Time Frame: Change from baseline after intervention, on average 1.5 hours after baseline measure
|
Change from baseline after intervention, on average 1.5 hours after baseline measure
|
Change in score of Visual Analog Scale for pain
Time Frame: Change from baseline after intervention, on average 1.5 hours after baseline measure
|
Change from baseline after intervention, on average 1.5 hours after baseline measure
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Study Director: Victoria Galea, PhD, McMaster University
- Study Chair: Joy MacDermid, PhD, McMaster University
- Study Chair: Linda Woodhouse, PhD, University of Alberta
- Study Chair: Anita Gross, MSc, McMaster University
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
General Publications
- 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.
- 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.
- Butler, D.S. (1991). SLR, The Slump Test in Mobilisation of the Nervous System (pp.130-135, 139-146). London (UK): Elsevier Limited.
- Cyriax J. Perineuritis. Br Med J. 1942 May 9;1(4244):578-80. doi: 10.1136/bmj.1.4244.578. No abstract available.
- DeLeo JA. Basic science of pain. J Bone Joint Surg Am. 2006 Apr;88 Suppl 2:58-62. doi: 10.2106/JBJS.E.01286.
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
- Shacklock, M. (1995). Neurodynamics. Physiotherapy, 81, 9-16.
- Shacklock, M. (2005a). Clinical neurodynamics: A new system of musculoskeletal treatment (pp. 2-29, 98-104, 154-158). London (UK): Elsevier Butterworth Heinemann.
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
May 1, 2011
Primary Completion (Actual)
October 1, 2011
Study Completion (Actual)
October 1, 2011
Study Registration Dates
First Submitted
July 22, 2011
First Submitted That Met QC Criteria
July 25, 2011
First Posted (Estimate)
July 26, 2011
Study Record Updates
Last Update Posted (Estimate)
February 8, 2012
Last Update Submitted That Met QC Criteria
February 7, 2012
Last Verified
July 1, 2011
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 10-541
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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