Neural Dynamics Technique for the Treatment of Chronic Radicular Low Back Pain
Primary Purpose
Low Back Pain, Sciatica
Status
Completed
Phase
Not Applicable
Locations
Israel
Study Type
Interventional
Intervention
neural dynamics techniques treatment
placebo treatment
Sponsored by
About this trial
This is an interventional treatment trial for Low Back Pain focused on measuring Low back pain, Sciatica, Pain, Physiotherapy
Eligibility 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
Sites / Locations
- Clalit Health Services, Haifa and Western Galilee District
Outcomes
Primary Outcome Measures
Efficacy of neural dynamics technique
Efficacy will be measured by combining 5 tools
Oswestry disability index.
McGill Pain Questionnaire
Visual analog scale for pain assessment.
Lumbar flexion measurement (the distance of the tip of the index finger to the inferior angle of the Patella, measured by a measurement tape.
Passive SLR range of motion- measured with inclinometer
Secondary Outcome Measures
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT01145105
Brief Title
Neural Dynamics Technique for the Treatment of Chronic Radicular Low Back Pain
Official Title
Efficacy of Neural Dynamics Technique in the Treatment of Chronic Low Back Pain With Radiation to the Leg
Study Type
Interventional
2. Study Status
Record Verification Date
July 2011
Overall Recruitment Status
Completed
Study Start Date
June 2010 (undefined)
Primary Completion Date
July 2011 (Actual)
Study Completion Date
July 2011 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Clalit Health Services
4. Oversight
Data Monitoring Committee
No
5. Study Description
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.
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;
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Low Back Pain, Sciatica
Keywords
Low back pain, Sciatica, Pain, Physiotherapy
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
34 (Actual)
8. Arms, Groups, and Interventions
Intervention Type
Procedure
Intervention Name(s)
neural dynamics techniques treatment
Other Intervention Name(s)
Physiotherapy
Intervention Description
Treatment group- will receive neural mobilizations techniques, to improve movement of the sciatic nerve.
Intervention Type
Procedure
Intervention Name(s)
placebo treatment
Other Intervention Name(s)
physiotherapy
Intervention Description
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.
Primary Outcome Measure Information:
Title
Efficacy of neural dynamics technique
Description
Efficacy will be measured by combining 5 tools
Oswestry disability index.
McGill Pain Questionnaire
Visual analog scale for pain assessment.
Lumbar flexion measurement (the distance of the tip of the index finger to the inferior angle of the Patella, measured by a measurement tape.
Passive SLR range of motion- measured with inclinometer
Time Frame
5 weeks
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Noga Roguin Maor, MD
Organizational Affiliation
clinical research unit, Clalit health services, Haifa and western Galilee district.
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Uzi Milman, MD
Organizational Affiliation
clinical research unit, Clalit health services, Haifa and western Galilee district.
Official's Role
Study Director
Facility Information:
Facility Name
Clalit Health Services, Haifa and Western Galilee District
City
Haifa
Country
Israel
12. IPD Sharing Statement
Learn more about this trial
Neural Dynamics Technique for the Treatment of Chronic Radicular Low Back Pain
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