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

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01954199
First Posted: October 1, 2013
Last Update Posted: June 2, 2016
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
Giovanni Esteves Ferreira, Federal University of Health Science of Porto Alegre
September 24, 2013
October 1, 2013
June 2, 2016
March 2015
April 2016   (Final data collection date for primary outcome measure)
  • 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)
  • Pain (numeric pain rating scale) [ Time Frame: Immediate ]
    Immediately after the intervention, the subjects will be asked about their post-treatment pain scores in the symptomatic leg and in the back, which will be measured with the numeric pain rating scale (NPRS). Pain will be assessed with individuals at rest
  • Pain (Numeric Pain Rating Scale) [ Time Frame: 1 week ]
    1 week after the intervention, the subjects will be asked about their current pain scores in the symptomatic leg and in the back, which will be measured with the numeric pain rating scale (NPRS). Pain will be assessed with individuals at rest.
Complete list of historical versions of study NCT01954199 on ClinicalTrials.gov Archive Site
  • 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
  • Straight leg raise range of motion [ Time Frame: Immediate ]
    With subjects lying in prone, an inclinometer will be positioned in the symptomatic (and therefore the treated) leg immediately after the intervention. Then, they will be instructed to raise their leg straightly. The mean range of motion (ROM) of 3 measures will be recorded.
  • Oswestry Disability Index [ Time Frame: 1 week ]
    One week after the intervention, individuals will be asked to complete the Oswestry Disability Index (ODI), which is a self-reported questionnaire that addresses functional restrictions in subjects with low back pain. This questionnaire is widely used, with good psychometric properties and excellent responsiveness and is also used in individuals with back-related leg pain.
Not Provided
Not Provided
 
The Effectiveness of Neurodynamic Techniques in Patients With Nerve-Related Leg Pain
The Effectiveness of Neurodynamic Techniques in Patients With Nerve-Related Leg Pain
This study aims to verify if patients with nerve-related leg pain benefits from neurodynamic treatment over two weeks.

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.

Interventional
Not Provided
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Treatment
  • Nerve Pain
  • Peripheral Nerve Injuries
  • Peripheral Nervous System Diseases
  • Sciatica
  • Low Back Pain
  • Low Back Ache
  • Signs and Symptoms
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
  • 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).
    Intervention: Procedure: Neurodynamic Group
  • 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.

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.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
60
April 2016
April 2016   (Final data collection date for primary outcome measure)

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
Sexes Eligible for Study: All
18 Years to 80 Years   (Adult, Senior)
No
Contact information is only displayed when the study is recruiting subjects
Brazil
 
 
NCT01954199
UFCSPA
Yes
Not Provided
Not Provided
Giovanni Esteves Ferreira, Federal University of Health Science of Porto Alegre
Federal University of Health Science of Porto Alegre
Not Provided
Study Chair: Marcelo F Silva, PhD Federal University of Health Sciences of Porto Alegre
Federal University of Health Science of Porto Alegre
June 2016

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP