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Neural Dynamics Technique for the Treatment of Chronic Radicular Low Back Pain

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ClinicalTrials.gov Identifier: NCT01145105
Recruitment Status : Completed
First Posted : June 16, 2010
Last Update Posted : November 10, 2011
Sponsor:
Information provided by (Responsible Party):
Uzi Milman, Clalit Health Services

Brief Summary:

Low back pain ( LBP) is a significant health problem which affects about 70%-80% of the population during the course of their life . The majority of LBP is resolved within 3 months; however, up to 40% of LBP becomes chronic. One subgroup of chronic LBP is patients with sciatica. Sciatica is characterized by radiating pain to the buttock and lower limb, with or without low back pain.

It has been shown in the upper limb that by positioning the contra-lateral arm in tension the investigators actually reduce tension in the ipsilateral arm. Patients, who present with symptoms like sciatica, can benefit from this maneuver (neural dynamics techniques) that reduces tension through the contra-lateral leg.

Working Hypothesis: Compared with a placebo maneuver of the upper limb, the neural dynamics techniques will result in better rehabilitation of individuals with radicular LBP.


Condition or disease Intervention/treatment Phase
Low Back Pain Sciatica Procedure: neural dynamics techniques treatment Procedure: placebo treatment Not Applicable

Detailed Description:
Objectives: To evaluate the efficacy of neural dynamics techniques, using the contra-lateral leg, in the treatment of sub-acute/chronic Low back pain with radiation to the leg. Study Methodology: Eligible individuals will be assessed by a physiotherapist that will be blinded to the treatment allocation; treatment (either intervention or placebo) will be provided by a physiotherapist that will be blinded to the patient's assessment. The treated individuals and the referring physician will also be blinded to the treatment allocation;

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 34 participants
Allocation: Randomized
Intervention Model: Single Group Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Efficacy of Neural Dynamics Technique in the Treatment of Chronic Low Back Pain With Radiation to the Leg
Study Start Date : June 2010
Actual Primary Completion Date : July 2011
Actual Study Completion Date : July 2011

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Back Pain Sciatica


Intervention Details:
  • Procedure: neural dynamics techniques treatment
    Treatment group- will receive neural mobilizations techniques, to improve movement of the sciatic nerve.
    Other Name: Physiotherapy
  • Procedure: placebo treatment
    Control group- will receive placebo treatment that will include mobilization to the upper limb. After the placebo treatment, these patients will receive neural mobilizations techniques.
    Other Name: physiotherapy


Primary Outcome Measures :
  1. Efficacy of neural dynamics technique [ Time Frame: 5 weeks ]

    Efficacy will be measured by combining 5 tools

    1. Oswestry disability index.
    2. McGill Pain Questionnaire
    3. Visual analog scale for pain assessment.
    4. Lumbar flexion measurement (the distance of the tip of the index finger to the inferior angle of the Patella, measured by a measurement tape.
    5. Passive SLR range of motion- measured with inclinometer



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Written consent
  • LBP with radiation to one leg, that lasts more than 6 weeks
  • Abnormal response to SLR test
  • With or without neurological signs

Exclusion Criteria:

  • History of spinal surgery
  • Patient with FUO
  • History of malignancies
  • Patient with saddle anesthesia

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01145105


Locations
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Israel
Clalit Health Services, Haifa and Western Galilee District
Haifa, Israel
Sponsors and Collaborators
Clalit Health Services
Investigators
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Principal Investigator: Noga Roguin Maor, MD clinical research unit, Clalit health services, Haifa and western Galilee district.
Study Director: Uzi Milman, MD clinical research unit, Clalit health services, Haifa and western Galilee district.
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Responsible Party: Uzi Milman, Uzi Milman MD, Clinical Research Unit, Clalit Health Services, Haifa District, HAIFA, ISRAEL., Clalit Health Services
ClinicalTrials.gov Identifier: NCT01145105    
Other Study ID Numbers: K-09-0078-ctil
First Posted: June 16, 2010    Key Record Dates
Last Update Posted: November 10, 2011
Last Verified: July 2011
Keywords provided by Uzi Milman, Clalit Health Services:
Low back pain
Sciatica
Pain
Physiotherapy
Additional relevant MeSH terms:
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Sciatica
Back Pain
Low Back Pain
Pain
Neurologic Manifestations
Signs and Symptoms
Sciatic Neuropathy
Mononeuropathies
Peripheral Nervous System Diseases
Neuromuscular Diseases
Nervous System Diseases
Neuralgia