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

Low Back Pain Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01954199
• Other study ID #: UFCSPA
• Status: Completed
• Phase: N/A
• First received: September 24, 2013
• Last updated: June 1, 2016
• Start date: March 2015
• Est. completion date: April 2016

Study information

• Verified date: June 2016
• Source: Federal University of Health Science of Porto Alegre
• Contact: n/a
• Is FDA regulated: No
• Health authority: Brazil: Ethics Committee
• Study type: Interventional

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 60
• Est. completion date: April 2016
• Est. primary completion date: April 2016
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 80 Years

Eligibility

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 Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Low Back Ache
• Low Back Pain
• Nerve Pain
• Nervous System Diseases
• Peripheral Nerve Injuries
• Peripheral Nervous System Diseases
• Sciatica
• Signs and Symptoms

Intervention

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.

Locations

Country	Name	City	State
Brazil	Federal University of Health Sciences of Porto Alegre	Porto Alegre	Rio Grande do sul

Sponsors (1)

Lead Sponsor	Collaborator
Federal University of Health Science of Porto Alegre

Country where clinical trial is conducted

Brazil, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Leg Pain Intensity	Leg Pain will be measured by a 0-10 Numeric Rating Scale (Pain NRS)	Two weeks after randomization	No
Primary	Disability	Disability will be measured by the Oswestry Disability Index (ODI)	Two weeks after randomization	No
Secondary	Leg pain Intensity	Leg Pain will me measured by a 0-10 Pain NRS	Four weeks after randomization	No
Secondary	Disability	Disability will be measured by the Oswestry Disability Index (ODI)	Four weeks after randomization	No
Secondary	Back pain intensity	Back Pain will me measured by an 0-10 Pain NRS	Two weeks after randomization	No
Secondary	Back pain intensity	Back Pain will me measured by an 0-10 Pain NRS	Four weeks after randomization	No
Secondary	Distribution of Symptoms	Distribution of symptoms will me measured by a body diagram	Two weeks, Four weeks after randomization	No
Secondary	Function	Function will be measured by the Patient-Specific Functional Scale (PSFS)	Two weeks, Four weeks after randomization	No
Secondary	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	No