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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT01402895
Other study ID # 10-541
Secondary ID
Status Completed
Phase N/A
First received July 22, 2011
Last updated February 7, 2012
Start date May 2011
Est. completion date October 2011

Study information

Verified date July 2011
Source McMaster University
Contact n/a
Is FDA regulated No
Health authority Canada: Ethics Review Committee
Study type Interventional

Clinical Trial Summary

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.


Recruitment information / eligibility

Status Completed
Enrollment 9
Est. completion date October 2011
Est. primary completion date October 2011
Accepts healthy volunteers No
Gender Both
Age group 18 Years and older
Eligibility 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 Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator, Outcomes Assessor), Primary Purpose: Treatment


Related Conditions & MeSH terms


Intervention

Other:
Exercise
Transversus abdominus exercise
Mobilizations
The physiotherapist will perform mobilizations to the L-spine and SI joints with the participant in a specific position.

Locations

Country Name City State
Canada McMaster University Hamilton Ontario

Sponsors (1)

Lead Sponsor Collaborator
McMaster University

Country where clinical trial is conducted

Canada, 

References & Publications (21)

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. — View Citation

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. — View Citation

DeLeo JA. Basic science of pain. J Bone Joint Surg Am. 2006 Apr;88 Suppl 2:58-62. Review. — View 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. — View 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.

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. — View 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. Epub 2006 Jun 9. Portuguese. — View 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. — View 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. — View 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. — View 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. — View 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. Epub 2005 Apr 20. Review. — View Citation

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. — View 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. — View 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. — View 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. — View 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. — View Citation

Zochodne DW, Low PA. Adrenergic control of nerve blood flow. Exp Neurol. 1990 Sep;109(3):300-7. — View Citation

* Note: There are 21 references in allClick here to view all references

Outcome

Type Measure Description Time frame Safety issue
Primary Change in nerve conduction studies 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 No
Secondary Change of knee extension in sitting slump test Change from baseline after intervention, on average 1.5 hours after baseline measure No
Secondary Change in score of Visual Analog Scale for pain Change from baseline after intervention, on average 1.5 hours after baseline measure No
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