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

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ClinicalTrials.gov Identifier: NCT01954199

Recruitment Status : Completed

First Posted : October 1, 2013

Last Update Posted : June 2, 2016

Sponsor:

Information provided by (Responsible Party):

Giovanni Esteves Ferreira, Federal University of Health Science of Porto Alegre

Study Description

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


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

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.

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

Primary Outcome Measures :

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

Secondary Outcome Measures :

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

Information from the National Library of Medicine

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Ages Eligible for Study:	18 Years to 80 Years (Adult, Older Adult)
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01954199

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

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 Key Record Dates
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

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