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

Study Description

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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Brief Summary:

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

Condition or disease	Intervention/treatment	Phase
Nerve Pain; Peripheral Nerve Injuries; Peripheral Nervous System Diseases; Sciatica; Low Back Pain; Low Back Ache; Signs and Symptoms	Procedure: Neurodynamic Group	Not Applicable

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 Design

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Study Type :	Interventional (Clinical Trial)
Actual Enrollment :	60 participants
Allocation:	Randomized
Intervention Model:	Parallel Assignment
Masking:	Single (Outcomes Assessor)
Primary Purpose:	Treatment
Official Title:	The Effectiveness of Neurodynamic Techniques in Patients With Nerve-Related Leg Pain
Study Start Date :	March 2015
Actual Primary Completion Date :	April 2016
Actual Study Completion Date :	April 2016

Arms and Interventions

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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

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.

Outcome Measures

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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Primary Outcome Measures :

1. Leg Pain Intensity [ Time Frame: Two weeks after randomization ]
   Leg Pain will be measured by a 0-10 Numeric Rating Scale (Pain NRS)
2. Disability [ Time Frame: Two weeks after randomization ]
   Disability will be measured by the Oswestry Disability Index (ODI)

Secondary Outcome Measures :

1. Leg pain Intensity [ Time Frame: Four weeks after randomization ]
   Leg Pain will me measured by a 0-10 Pain NRS
2. Disability [ Time Frame: Four weeks after randomization ]
   Disability will be measured by the Oswestry Disability Index (ODI)
3. Back pain intensity [ Time Frame: Two weeks after randomization ]
   Back Pain will me measured by an 0-10 Pain NRS
4. Back pain intensity [ Time Frame: Four weeks after randomization ]
   Back Pain will me measured by an 0-10 Pain NRS
5. Distribution of Symptoms [ Time Frame: Two weeks, Four weeks after randomization ]
   Distribution of symptoms will me measured by a body diagram
6. Function [ Time Frame: Two weeks, Four weeks after randomization ]
   Function will be measured by the Patient-Specific Functional Scale (PSFS)
7. 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

Eligibility Criteria

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Ages Eligible for Study:	18 Years to 80 Years (Adult, Senior)
Sexes Eligible for Study:	All
Accepts Healthy Volunteers:	No

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

Contacts and Locations

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Locations

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

Sponsors and Collaborators

Federal University of Health Science of Porto Alegre

Investigators

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

More Information

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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

Ferreira G, Stieven F, Araujo F, Wiebusch M, Rosa C, Plentz R, Silva M. Neurodynamic treatment did not improve pain and disability at two weeks in patients with chronic nerve-related leg pain: a randomised trial. J Physiother. 2016 Oct;62(4):197-202. doi: 10.1016/j.jphys.2016.08.007. Epub 2016 Aug 24.

Responsible Party:	Giovanni Esteves Ferreira, Mr, Federal University of Health Science of Porto Alegre
ClinicalTrials.gov Identifier:	NCT01954199 History of Changes
Other Study ID Numbers:	UFCSPA
First Posted:	October 1, 2013
Last Update Posted:	June 2, 2016
Last Verified:	June 2016

Keywords provided by Giovanni Esteves Ferreira, Federal University of Health Science of Porto Alegre:

Sciatica; Nerve pain; Low back pain

Additional relevant MeSH terms:

Back Pain; Low Back Pain; Nervous System Diseases; Signs and Symptoms; Sciatica; Peripheral Nerve Injuries; Peripheral Nervous System Diseases; Neuralgia	Pain; Neurologic Manifestations; Sciatic Neuropathy; Mononeuropathies; Neuromuscular Diseases; Trauma, Nervous System; Wounds and Injuries