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

Study Overview
=================
Brief Summary
-----------------
This study aims to verify if patients with nerve-related leg pain benefits from neurodynamic treatment over two weeks.

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.

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

Conditions
-----------------
Nerve Pain, Peripheral Nerve Injuries, Peripheral Nervous System Diseases, Sciatica, Low Back Pain, Low Back Ache, Signs and Symptoms

Intervention / Treatment
-----------------
* Procedure: Neurodynamic Group


Participation Criteria
=================
Eligibility Criteria
-----------------
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

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 80 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Neurodynamic group<br>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<br>* 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.<br>* Other names: Nerve tissue management;|
| No Intervention: Control Group<br>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 | Leg Pain will be measured by a 0-10 Numeric Rating Scale (Pain NRS) | Two weeks after randomization | 
| Disability | 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 | Leg Pain will me measured by a 0-10 Pain NRS | Four weeks after randomization | 
| Disability | Disability will be measured by the Oswestry Disability Index (ODI) | Four weeks after randomization | 
| Back pain intensity | Back Pain will me measured by an 0-10 Pain NRS | Two weeks after randomization | 
| Back pain intensity | Back Pain will me measured by an 0-10 Pain NRS | Four weeks after randomization | 
| Distribution of Symptoms | Distribution of symptoms will me measured by a body diagram | Two weeks, Four weeks after randomization | 
| Function | Function will be measured by the Patient-Specific Functional Scale (PSFS) | Two weeks, Four weeks after randomization | 
| Global Perceived Effect | Global Perceived Effect will be measured by an 11-point (-5 to +5) Global Perceived Effect Scale | Two weeks, Four weeks after randomization | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Sciatica, Nerve pain, Low back pain