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

Low Back Pain Clinical Trial

Official title:

Efficacy of Neural Dynamics Technique in the Treatment of Chronic Low Back Pain With Radiation to the Leg

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01145105
• Other study ID #: K-09-0078-ctil
• Status: Completed
• Phase: N/A
• First received: May 24, 2010
• Last updated: November 9, 2011
• Start date: June 2010
• Est. completion date: July 2011

Study information

• Verified date: July 2011
• Source: Clalit Health Services
• Contact: n/a
• Is FDA regulated: No
• Health authority: Israel: Ministry of Health
• Study type: Interventional

Clinical Trial 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.

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;

Recruitment information / eligibility

• Status: Completed
• Enrollment: 34
• Est. completion date: July 2011
• Est. primary completion date: July 2011
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 65 Years

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Back Pain
• Low Back Pain
• Sciatica

Intervention

Procedure:
• neural dynamics techniques treatment
Treatment group- will receive neural mobilizations techniques, to improve movement of the sciatic nerve.
• 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.

Locations

Country	Name	City	State
Israel	Clalit Health Services, Haifa and Western Galilee District	Haifa

Sponsors (1)

Lead Sponsor	Collaborator
Clalit Health Services

Country where clinical trial is conducted

Israel, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	5 weeks	No