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

Primary Purpose

Nerve Pain, Peripheral Nerve Injuries, Peripheral Nervous System Diseases

Status
Completed
Phase
Not Applicable
Locations
Brazil
Study Type
Interventional
Intervention
Neurodynamic Group
Sponsored by
Federal University of Health Science of Porto Alegre
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Nerve Pain focused on measuring Sciatica, Nerve pain, Low back pain

Eligibility Criteria

18 Years - 80 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Federal University of Health Sciences of Porto Alegre

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

No Intervention

Arm Label

Neurodynamic group

Control Group

Arm Description

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).

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.

Outcomes

Primary Outcome Measures

Leg Pain Intensity
Leg Pain will be measured by a 0-10 Numeric Rating Scale (Pain NRS)
Disability
Disability will be measured by the Oswestry Disability Index (ODI)

Secondary Outcome Measures

Leg pain Intensity
Leg Pain will me measured by a 0-10 Pain NRS
Disability
Disability will be measured by the Oswestry Disability Index (ODI)
Back pain intensity
Back Pain will me measured by an 0-10 Pain NRS
Back pain intensity
Back Pain will me measured by an 0-10 Pain NRS
Distribution of Symptoms
Distribution of symptoms will me measured by a body diagram
Function
Function will be measured by the Patient-Specific Functional Scale (PSFS)
Global Perceived Effect
Global Perceived Effect will be measured by an 11-point (-5 to +5) Global Perceived Effect Scale

Full Information

First Posted
September 24, 2013
Last Updated
June 1, 2016
Sponsor
Federal University of Health Science of Porto Alegre
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1. Study Identification

Unique Protocol Identification Number
NCT01954199
Brief Title
The Effectiveness of Neurodynamic Techniques in Patients With Nerve-Related Leg Pain
Official Title
The Effectiveness of Neurodynamic Techniques in Patients With Nerve-Related Leg Pain
Study Type
Interventional

2. Study Status

Record Verification Date
June 2016
Overall Recruitment Status
Completed
Study Start Date
March 2015 (undefined)
Primary Completion Date
April 2016 (Actual)
Study Completion Date
April 2016 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Federal University of Health Science of Porto Alegre

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Nerve Pain, Peripheral Nerve Injuries, Peripheral Nervous System Diseases, Sciatica, Low Back Pain, Low Back Ache, Signs and Symptoms
Keywords
Sciatica, Nerve pain, Low back pain

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
60 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Neurodynamic group
Arm Type
Experimental
Arm Description
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).
Arm Title
Control Group
Arm Type
No Intervention
Arm Description
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.
Intervention Type
Procedure
Intervention Name(s)
Neurodynamic Group
Other Intervention Name(s)
Neural mobilization, Sliders, Tensioners, Nerve tissue management
Intervention Description
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.
Primary Outcome Measure Information:
Title
Leg Pain Intensity
Description
Leg Pain will be measured by a 0-10 Numeric Rating Scale (Pain NRS)
Time Frame
Two weeks after randomization
Title
Disability
Description
Disability will be measured by the Oswestry Disability Index (ODI)
Time Frame
Two weeks after randomization
Secondary Outcome Measure Information:
Title
Leg pain Intensity
Description
Leg Pain will me measured by a 0-10 Pain NRS
Time Frame
Four weeks after randomization
Title
Disability
Description
Disability will be measured by the Oswestry Disability Index (ODI)
Time Frame
Four weeks after randomization
Title
Back pain intensity
Description
Back Pain will me measured by an 0-10 Pain NRS
Time Frame
Two weeks after randomization
Title
Back pain intensity
Description
Back Pain will me measured by an 0-10 Pain NRS
Time Frame
Four weeks after randomization
Title
Distribution of Symptoms
Description
Distribution of symptoms will me measured by a body diagram
Time Frame
Two weeks, Four weeks after randomization
Title
Function
Description
Function will be measured by the Patient-Specific Functional Scale (PSFS)
Time Frame
Two weeks, Four weeks after randomization
Title
Global Perceived Effect
Description
Global Perceived Effect will be measured by an 11-point (-5 to +5) Global Perceived Effect Scale
Time Frame
Two weeks, Four weeks after randomization

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Marcelo F Silva, PhD
Organizational Affiliation
Federal University of Health Sciences of Porto Alegre
Official's Role
Study Chair
Facility Information:
Facility Name
Federal University of Health Sciences of Porto Alegre
City
Porto Alegre
State/Province
Rio Grande do sul
ZIP/Postal Code
90050-170
Country
Brazil

12. IPD Sharing Statement

Citations:
PubMed Identifier
27634158
Citation
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.
Results Reference
derived

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

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