Low Back PainNCT01402895
The Effect Of A Neurodynamic Treatment On Nerve Conduction In Clients With Low Back Pain
A study testing Exercise and Mobilizations in people with Low Back Pain, run by McMaster University at 1 site in Canada.
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… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Low Back Pain
- What is being tested?
- Exercise and Mobilizations
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 9 participants
- Where
- 1 siteCanada
- Study dates
- May 2011to Oct 2011
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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)
Trial locations and contacts
1 site in 1 country.
About this study
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.
- Conditions
- Low Back Pain
- Being tested
- Exercise, Mobilizations
- Keywords
- Nerve conduction, H-reflex, mobilizations, with neurodynamic component
- Medical subject headings
- Low Back Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ExerciseOther
Transversus abdominus exercise
MobilizationsOther
The physiotherapist will perform mobilizations to the L-spine and SI joints with the participant in a specific position.
| Study group | Role | What they receive |
|---|---|---|
| Mobilizations | Active comparator | The physiotherapist will perform mobilizations to the L-spine and SI joints with the participant in a specific position. Receives: 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. Receives: Other: Exercise |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in nerve conduction studies
Motor conduction of the tibial nerve; Sensory conduction of the sural nerve; H-reflex, H:M ratio (soleus muscle)
Measured: Change from baseline after intervention, on average 1.5 hours after baseline measure
Secondary outcomes (2)
Change of knee extension in sitting slump test
Measured: Change from baseline after intervention, on average 1.5 hours after baseline measure
Change in score of Visual Analog Scale for pain
Measured: Change from baseline after intervention, on average 1.5 hours after baseline measure
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Jul 2011 (estimated)
- Study startMay 2011
- Primary completionOct 2011
- Study completionOct 2011
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (21)Papers the sponsor has linked to this study.
- Other trials for Low Back PainStudies of the same condition, open and under way.
- More trials run by McMaster UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 9 participants (actual)
Sponsor and investigators
- Lead sponsor
- McMaster University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Victoria Galea, PhD, Study director, McMaster UniversityJoy MacDermid, PhD, Study chair, McMaster UniversityLinda Woodhouse, PhD, Study chair, University of AlbertaAnita Gross, MSc, Study chair, McMaster University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01402895
- Sponsor's protocol ID
- 10-541
- Status last verified
- Jul 2011
- First submitted
- 22 Jul 2011
- Last updated
- 8 Feb 2012
- Results posted
- No
- Data monitoring committee
- No
Publications
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.
PubMed 157532Butler, 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.
PubMed 20784219DeLeo JA. Basic science of pain. J Bone Joint Surg Am. 2006 Apr;88 Suppl 2:58-62. doi: 10.2106/JBJS.E.01286.
PubMed 16595445Gelberman 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.
PubMed 6883862Kimura, 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.
PubMed 4707307Mahmud 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.
PubMed 16791369Maitland GD. Negative disc exploration: positive canal signs. Aust J Physiother. 1979 Jul;25(3):129-34. doi: 10.1016/S0004-9514(14)61220-4.
PubMed 25026403Nakamichi 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.
PubMed 7594983Ogata 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.
PubMed 3958526Schaafsma 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.
PubMed 9038924Shacklock, 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.
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.
PubMed 16038853
Study at a glance
From the registry record, last updated by the sponsor on 8 Feb 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect Of A Neurodynamic Treatment On Nerve Conduction In Clients With Low Back Pain
- ClinicalTrials.gov ID
- NCT01402895
- Acronym / sponsor ID
- 10-541
- Conditions
- Low Back Pain
- Keywords
- Nerve conduction, H-reflex, mobilizations, with neurodynamic component
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 9 participants (actual)
- Lead sponsor
- McMaster UniversityUniversity, hospital or other
- Study start
- May 2011
- Primary completion
- Oct 2011 (actual)
- Study completion
- Oct 2011 (actual)
- First posted
- 26 Jul 2011 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Mobilizations | Active comparator | Other: MobilizationsThe physiotherapist will perform mobilizations to the L-spine and SI joints with the participant in a specific position. |
| Exercise | Active comparator | Other: ExerciseThe physiotherapist will teach the participant how to tighten the transversus abdominus muscle. The participant will be asked to do a series of these exercises. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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.
Key exclusion criteria (3 listed)
- 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)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| ExerciseTransversus abdominus exercise | Other | Exercise |
| MobilizationsThe physiotherapist will perform mobilizations to the L-spine and SI joints with the participant in a specific position. | Other | Mobilizations |
Primary outcome
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)
2 secondary outcomes
Change of knee extension in sitting slump test
Time frame: 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
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Feb 2012.
- Background: PubMed 157532Breig 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.
- BackgroundButler, D.S. (1991). SLR, The Slump Test in Mobilisation of the Nervous System (pp.130-135, 139-146). London (UK): Elsevier Limited.
- Background: PubMed 20784219Cyriax J. Perineuritis. Br Med J. 1942 May 9;1(4244):578-80. doi: 10.1136/bmj.1.4244.578. No abstract available.
- Background: PubMed 16595445DeLeo JA. Basic science of pain. J Bone Joint Surg Am. 2006 Apr;88 Suppl 2:58-62. doi: 10.2106/JBJS.E.01286.
- Background: PubMed 6883862Gelberman 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.
- BackgroundKimura, 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: PubMed 4707307Lundborg 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.
- Background: PubMed 16791369Mahmud 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.
- Background: PubMed 25026403Maitland GD. Negative disc exploration: positive canal signs. Aust J Physiother. 1979 Jul;25(3):129-34. doi: 10.1016/S0004-9514(14)61220-4.
- Background: PubMed 7594983Nakamichi 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.
- Background: PubMed 3958526Ogata 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.
- Background: PubMed 9038924Schaafsma 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Victoria Galea, PhD study director
McMaster University
Joy MacDermid, PhD study chair
McMaster University
Linda Woodhouse, PhD study chair
University of Alberta
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Exercise and Mobilizations in people with Low Back Pain, run by McMaster University at 1 site in Canada.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 8 Feb 2012. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in nerve conduction studies (time frame: Change from baseline after intervention, on average 1.5 hours after baseline measure). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01402895, which also lists 21 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 Feb 2012.