NCT01402895

Brief 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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
9

participants targeted

Target at below P25 for not_applicable low-back-pain

Timeline
Completed

Started May 2011

Shorter than P25 for not_applicable low-back-pain

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

May 1, 2011

Completed
3 months until next milestone

First Submitted

Initial submission to the registry

July 22, 2011

Completed
4 days until next milestone

First Posted

Study publicly available on registry

July 26, 2011

Completed
2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 1, 2011

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

October 1, 2011

Completed
Last Updated

February 8, 2012

Status Verified

July 1, 2011

Enrollment Period

5 months

First QC Date

July 22, 2011

Last Update Submit

February 7, 2012

Conditions

Low Back Pain

Keywords

Nerve conductionH-reflex, mobilizationswith neurodynamic component

Outcome Measures

Primary Outcomes (1)

  • 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

Secondary Outcomes (2)

  • Change of knee extension in sitting slump test

    Change from baseline after intervention, on average 1.5 hours after baseline measure

  • Change in score of Visual Analog Scale for pain

    Change from baseline after intervention, on average 1.5 hours after baseline measure

Study Arms (2)

Mobilizations

ACTIVE COMPARATOR

The physiotherapist will perform mobilizations to the L-spine and SI joints with the participant in a specific position.

Other: Mobilizations

Exercise

ACTIVE COMPARATOR

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.

Other: Exercise

Interventions

ExerciseOTHER

Transversus abdominus exercise

Exercise
MobilizationsOTHER

The physiotherapist will perform mobilizations to the L-spine and SI joints with the participant in a specific position.

Mobilizations

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • 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)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

McMaster University

Hamilton, Ontario, Canada

Location

Related 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. doi: 10.1097/00007632-197905000-00011.

    PMID: 157532BACKGROUND

  • Butler, D.S. (1991). SLR, The Slump Test in Mobilisation of the Nervous System (pp.130-135, 139-146). London (UK): Elsevier Limited.

    BACKGROUND

  • Cyriax J. Perineuritis. Br Med J. 1942 May 9;1(4244):578-80. doi: 10.1136/bmj.1.4244.578. No abstract available.

    PMID: 20784219BACKGROUND

  • 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: 16595445BACKGROUND

  • 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.

    PMID: 6883862BACKGROUND

  • 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.

    BACKGROUND

  • 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: 4707307BACKGROUND

  • 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: 16791369BACKGROUND

  • 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: 25026403BACKGROUND

  • 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: 7594983BACKGROUND

  • 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: 3958526BACKGROUND

  • 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.

    PMID: 9038924BACKGROUND

  • Shacklock, M. (1995). Neurodynamics. Physiotherapy, 81, 9-16.

    BACKGROUND

  • Shacklock, M. (2005a). Clinical neurodynamics: A new system of musculoskeletal treatment (pp. 2-29, 98-104, 154-158). London (UK): Elsevier Butterworth Heinemann.

    BACKGROUND

  • 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: 16038853BACKGROUND

  • 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: 15128188BACKGROUND

  • 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: 15375820BACKGROUND

  • 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: 14784487BACKGROUND

  • 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: 1855142BACKGROUND

  • 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: 2397398BACKGROUND

  • 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.

    PMID: 2285433BACKGROUND

MeSH Terms

Conditions

Low Back Pain

Interventions

Exercise

Condition Hierarchy (Ancestors)

Back PainPainNeurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Motor ActivityMovementMusculoskeletal Physiological PhenomenaMusculoskeletal and Neural Physiological Phenomena

Study Officials

  • Victoria Galea, PhD

    McMaster University

    STUDY DIRECTOR

  • Joy MacDermid, PhD

    McMaster University

    STUDY CHAIR

  • Linda Woodhouse, PhD

    University of Alberta

    STUDY CHAIR

  • Anita Gross, MSc

    McMaster University

    STUDY CHAIR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
TRIPLE
Who Masked
PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

July 22, 2011

First Posted

July 26, 2011

Study Start

May 1, 2011

Primary Completion

October 1, 2011

Study Completion

October 1, 2011

Last Updated

February 8, 2012

Record last verified: 2011-07

Locations

CA(1)