The Effectiveness of Neurodynamic Techniques in Patients With Nerve-Related Leg Pain

June 1, 2016 updated by: Giovanni Esteves Ferreira, Federal University of Health Science of Porto Alegre
This study aims to verify if patients with nerve-related leg pain benefits from neurodynamic treatment over two weeks.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

Nerve-related leg pain (NRLP) although less prevalent than low back pain itself, is associated with higher economic and social burden, and has been considered a predictor of chronicity and disability among subjects with low back pain.

Numerous approaches are proposed for its management; however, evidence regarding the best therapeutic approach is lacking. Neurodynamic techniques are proposed to be effective to manage NRLP.

Thus, this study aims to verify, through a randomized controlled trial, the effectiveness of a two-week program of neurodynamic techniques on pain and disability in individuals with NRLP.

Study Type

Interventional

Enrollment (Actual)

60

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Brazil
    • Rio Grande do sul
      • Porto Alegre, Rio Grande do sul, Brazil, 90050-170
        • Federal University of Health Sciences of Porto Alegre

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

14 years to 76 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion criteria:

  • unilateral leg pain (Intensity ≥ 3)
  • Pain distal to the buttocks
  • Reproduction of symptoms and change in symptoms with structural differentiation (cervical return to neutral position or ankle dorsiflexion) with slump test;

Exclusion criteria:

  • cauda equina syndrome;
  • bilateral leg pain;
  • crossed Lasègue sign;
  • previous surgery in the lumbar spine;
  • inflammatory arthropathies;
  • malignancy
  • being in litigation or in work-compensation due to back and/or leg pain
  • being receiving physiotherapy treatment at the time of baseline assessment

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Neurodynamic group
Patients allocated to this group will receive three different neurodynamic techniques: a lumbar foramen dynamic opener; a side-lying slider and a slider in the slump position. Patients will be asked to perform home exercises (a slider and a tensioner technique). Treatment will receive four treatments during two weeks (two sessions/week).
Procedure: Neurodynamic Group

All techniques will be executed in a pain-free way (grade III). Mild discomfort will be accepted, but it must subside as soon as the technique ends.

  • In the dynamic opener technique, patient will be positioned in side-lying, with the affected side upwards. The therapist will then perform grade III oscillations aiming to open the lumbar foramen;
  • In the side-lying slider, the patient will be in side-lying with the affected side upwards. A combination of knee and hip flexion and extension movements will produce sliding in the neural structures;
  • In the slump slider, the patient will be seated in slump position. Combinations between neck and knee movements will produce greater nerve excursion than the side-lying slider. Patients will perform the slump slider in a pain-free manner.
Other Names:
  • Neural mobilization
  • Sliders
  • Tensioners
  • Nerve tissue management
No Intervention: Control Group

Patients allocated to Control Group (CG) will receive no intervention and will be advised according to the best evidence available; i.e, advice to remain active and to resume activities of daily living

Upon trial completion, treatment will be offered.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Leg Pain Intensity
Time Frame: Two weeks after randomization
Leg Pain will be measured by a 0-10 Numeric Rating Scale (Pain NRS)
Two weeks after randomization
Disability
Time Frame: Two weeks after randomization
Disability will be measured by the Oswestry Disability Index (ODI)
Two weeks after randomization

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Leg pain Intensity
Time Frame: Four weeks after randomization
Leg Pain will me measured by a 0-10 Pain NRS
Four weeks after randomization
Disability
Time Frame: Four weeks after randomization
Disability will be measured by the Oswestry Disability Index (ODI)
Four weeks after randomization
Back pain intensity
Time Frame: Two weeks after randomization
Back Pain will me measured by an 0-10 Pain NRS
Two weeks after randomization
Back pain intensity
Time Frame: Four weeks after randomization
Back Pain will me measured by an 0-10 Pain NRS
Four weeks after randomization
Distribution of Symptoms
Time Frame: Two weeks, Four weeks after randomization
Distribution of symptoms will me measured by a body diagram
Two weeks, Four weeks after randomization
Function
Time Frame: Two weeks, Four weeks after randomization
Function will be measured by the Patient-Specific Functional Scale (PSFS)
Two weeks, Four weeks after randomization
Global Perceived Effect
Time Frame: Two weeks, Four weeks after randomization
Global Perceived Effect will be measured by an 11-point (-5 to +5) Global Perceived Effect Scale
Two weeks, Four weeks after randomization

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Federal University of Health Science of Porto Alegre

Investigators

  • Study Chair: Marcelo F Silva, PhD, Federal University of Health Sciences of Porto Alegre

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

March 1, 2015

Primary Completion (Actual)

April 1, 2016

Study Completion (Actual)

April 1, 2016

Study Registration Dates

First Submitted

September 24, 2013

First Submitted That Met QC Criteria

September 26, 2013

First Posted (Estimate)

October 1, 2013

Study Record Updates

Last Update Posted (Estimate)

June 2, 2016

Last Update Submitted That Met QC Criteria

June 1, 2016

Last Verified

June 1, 2016

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • UFCSPA

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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