The Effectiveness of Neurodynamic Techniques in Patients With Nerve-Related Leg Pain
1 other identifier
interventional
60
1 country
1
Brief Summary
This study aims to verify if patients with nerve-related leg pain benefits from neurodynamic treatment over two weeks.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for not_applicable
Started Mar 2015
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
September 24, 2013
CompletedFirst Posted
Study publicly available on registry
October 1, 2013
CompletedStudy Start
First participant enrolled
March 1, 2015
CompletedPrimary Completion
Last participant's last visit for primary outcome
April 1, 2016
CompletedStudy Completion
Last participant's last visit for all outcomes
April 1, 2016
CompletedJune 2, 2016
June 1, 2016
1.1 years
September 24, 2013
June 1, 2016
Conditions
Keywords
Outcome Measures
Primary Outcomes (2)
Leg Pain Intensity
Leg Pain will be measured by a 0-10 Numeric Rating Scale (Pain NRS)
Two weeks after randomization
Disability
Disability will be measured by the Oswestry Disability Index (ODI)
Two weeks after randomization
Secondary Outcomes (7)
Leg pain Intensity
Four weeks after randomization
Disability
Four weeks after randomization
Back pain intensity
Two weeks after randomization
Back pain intensity
Four weeks after randomization
Distribution of Symptoms
Two weeks, Four weeks after randomization
- +2 more secondary outcomes
Study Arms (2)
Neurodynamic group
EXPERIMENTALPatients 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).
Control Group
NO INTERVENTIONPatients 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.
Interventions
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.
Eligibility Criteria
You may qualify if:
- 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;
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Federal University of Health Sciences of Porto Alegre
Porto Alegre, Rio Grande do Sul, 90050-170, Brazil
Related Publications (1)
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.
PMID: 27634158DERIVED
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- STUDY CHAIR
Marcelo F Silva, PhD
Federal University of Health Sciences of Porto Alegre
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- SINGLE
- Who Masked
- OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Mr
Study Record Dates
First Submitted
September 24, 2013
First Posted
October 1, 2013
Study Start
March 1, 2015
Primary Completion
April 1, 2016
Study Completion
April 1, 2016
Last Updated
June 2, 2016
Record last verified: 2016-06