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

Sponsor
Federal University of Health Science of Porto Alegre (Other)
Overall Status
Completed
CT.gov ID
NCT01954199
Collaborator
(none)
60
1
2
13
4.6

Study Details

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
  • Procedure: Neurodynamic Group
N/A

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
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 :
Mar 1, 2015
Actual Primary Completion Date :
Apr 1, 2016
Actual Study Completion Date :
Apr 1, 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.

    Outcome Measures

    Primary Outcome Measures

    1. Leg Pain Intensity [Two weeks after randomization]

      Leg Pain will be measured by a 0-10 Numeric Rating Scale (Pain NRS)

    2. Disability [Two weeks after randomization]

      Disability will be measured by the Oswestry Disability Index (ODI)

    Secondary Outcome Measures

    1. Leg pain Intensity [Four weeks after randomization]

      Leg Pain will me measured by a 0-10 Pain NRS

    2. Disability [Four weeks after randomization]

      Disability will be measured by the Oswestry Disability Index (ODI)

    3. Back pain intensity [Two weeks after randomization]

      Back Pain will me measured by an 0-10 Pain NRS

    4. Back pain intensity [Four weeks after randomization]

      Back Pain will me measured by an 0-10 Pain NRS

    5. Distribution of Symptoms [Two weeks, Four weeks after randomization]

      Distribution of symptoms will me measured by a body diagram

    6. Function [Two weeks, Four weeks after randomization]

      Function will be measured by the Patient-Specific Functional Scale (PSFS)

    7. Global Perceived Effect [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

    Criteria

    Ages Eligible for Study:
    18 Years to 80 Years
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    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

    Locations

    Site City State Country Postal Code
    1 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

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Giovanni Esteves Ferreira, Mr, Federal University of Health Science of Porto Alegre
    ClinicalTrials.gov Identifier:
    NCT01954199
    Other Study ID Numbers:
    • UFCSPA
    First Posted:
    Oct 1, 2013
    Last Update Posted:
    Jun 2, 2016
    Last Verified:
    Jun 1, 2016
    Keywords provided by Giovanni Esteves Ferreira, Mr, Federal University of Health Science of Porto Alegre
    Additional relevant MeSH terms:

    Study Results

    No Results Posted as of Jun 2, 2016