NCT01954199

Brief Summary

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

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
60

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Mar 2015

Geographic Reach
1 country

1 active site

Status
completed

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

Completed
7 days until next milestone

First Posted

Study publicly available on registry

October 1, 2013

Completed
1.4 years until next milestone

Study Start

First participant enrolled

March 1, 2015

Completed
1.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 1, 2016

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

April 1, 2016

Completed
Last Updated

June 2, 2016

Status Verified

June 1, 2016

Enrollment Period

1.1 years

First QC Date

September 24, 2013

Last Update Submit

June 1, 2016

Conditions

Keywords

SciaticaNerve painLow back pain

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

EXPERIMENTAL

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

Control Group

NO INTERVENTION

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.

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.

Also known as: Neural mobilization, Sliders, Tensioners, Nerve tissue management
Neurodynamic group

Eligibility Criteria

Age18 Years - 80 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

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

Location

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.

MeSH Terms

Conditions

NeuralgiaPeripheral Nerve InjuriesPeripheral Nervous System DiseasesSciaticaLow Back PainSigns and Symptoms

Condition Hierarchy (Ancestors)

Neuromuscular DiseasesNervous System DiseasesPainNeurologic ManifestationsPathological Conditions, Signs and SymptomsTrauma, Nervous SystemWounds and InjuriesSciatic NeuropathyMononeuropathiesBack Pain

Study Officials

  • Marcelo F Silva, PhD

    Federal University of Health Sciences of Porto Alegre

    STUDY CHAIR

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

Locations