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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Uzi Milman, Clalit Health Services
ClinicalTrials.gov Identifier:
NCT01145105
First received: May 24, 2010
Last updated: November 9, 2011
Last verified: July 2011
  Purpose

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 Intervention
Low Back Pain
Sciatica
Procedure: neural dynamics techniques treatment
Procedure: placebo treatment

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Double Blind (Subject, Caregiver, 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

Resource links provided by NLM:


Further study details as provided by Clalit Health Services:

Primary Outcome Measures:
  • Efficacy of neural dynamics technique [ Time Frame: 5 weeks ] [ Designated as safety issue: No ]

    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


Enrollment: 34
Study Start Date: June 2010
Study Completion Date: July 2011
Primary Completion Date: July 2011 (Final data collection date for primary outcome measure)
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
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;

  Eligibility

Ages Eligible for Study:   18 Years to 65 Years
Genders Eligible for Study:   Both
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01145105

Locations
Israel
Clalit Health Services, Haifa and Western Galilee District
Haifa, Israel
Sponsors and Collaborators
Clalit Health Services
Investigators
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.
  More Information

No publications provided

Responsible Party: Uzi Milman, Uzi Milman MD, Clinical Research Unit, Clalit Health Services, Haifa District, HAIFA, ISRAEL., Clalit Health Services
ClinicalTrials.gov Identifier: NCT01145105     History of Changes
Other Study ID Numbers: K-09-0078-ctil
Study First Received: May 24, 2010
Last Updated: November 9, 2011
Health Authority: Israel: Ministry of Health

Keywords provided by Clalit Health Services:
Low back pain
Sciatica
Pain
Physiotherapy

Additional relevant MeSH terms:
Back Pain
Low Back Pain
Sciatica
Pain
Neurologic Manifestations
Nervous System Diseases
Signs and Symptoms
Neuralgia
Sciatic Neuropathy
Mononeuropathies
Peripheral Nervous System Diseases
Neuromuscular Diseases

ClinicalTrials.gov processed this record on July 31, 2014