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

This study is not yet open for participant recruitment. (see Contacts and Locations)
Verified August 2014 by Federal University of Health Science of Porto Alegre
Sponsor:
Information provided by (Responsible Party):
Giovanni Esteves Ferreira, Federal University of Health Science of Porto Alegre
ClinicalTrials.gov Identifier:
NCT01954199
First received: September 24, 2013
Last updated: September 2, 2014
Last verified: August 2014
  Purpose

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.


Condition Intervention
Nerve Pain
Peripheral Nerve Injuries
Peripheral Nervous System Diseases
Sciatica
Low Back Pain
Low Back Ache
Signs and Symptoms
Procedure: Neurodynamic Group

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single Blind (Outcomes Assessor)
Primary Purpose: Treatment
Official Title: The Effectiveness of Neurodynamic Techniques in Patients With Nerve-Related Leg Pain

Resource links provided by NLM:


Further study details as provided by Federal University of Health Science of Porto Alegre:

Primary Outcome Measures:
  • Leg Pain Intensity [ Time Frame: Two weeks after randomization ] [ Designated as safety issue: No ]
    Leg Pain will be measured by an 0-10 Numeric Rating Scale (Pain NRS)

  • Disability [ Time Frame: Two weeks after randomization ] [ Designated as safety issue: No ]
    Disability will be measured by the Oswestry Disability Index (ODI)


Secondary Outcome Measures:
  • Leg Pain Intensity [ Time Frame: Four weeks after randomization ] [ Designated as safety issue: No ]
    Leg Pain will me measured by an 0-10 Pain NRS

  • Disability [ Time Frame: Four Weeks after randomization ] [ Designated as safety issue: No ]
    Disability will be measured by the Oswestry Disability Index (ODI)

  • Distribution of Symptoms [ Time Frame: Two weeks, Four weeks after randomization ] [ Designated as safety issue: No ]
    Distribution of symptoms will me measured by a body diagram

  • Function [ Time Frame: Two weeks, Four weeks after randomization ] [ Designated as safety issue: No ]
    Function will be measured by the Patient-Specific Functional Scale (PSFS)

  • Global Perceived Effect [ Time Frame: Two weeks, Four weeks after randomization ] [ Designated as safety issue: No ]
    Global Perceived Effect will be measured by an 11-point (-5 to +5) Global Perceived Effect Scale

  • Pressure Pain Threshold of the sciatic, femoral and common peroneal nerve trunks [ Time Frame: Two weeks, Four weeks after randomization ] [ Designated as safety issue: No ]
    Pressure Pain Threshold (PPT) will be measured by an digital algometer

  • Passive Straight Leg Raise range of motion [ Time Frame: Two weeks, Four weeks after randomization ] [ Designated as safety issue: No ]
    Passive Straight Leg Raise (pSLR) range of motion will be measured by a analogic inclinometer.


Estimated Enrollment: 60
Study Start Date: November 2014
Estimated Study Completion Date: April 2016
Estimated Primary Completion Date: December 2015 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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.


  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion criteria:

  • age greater than 18 years;
  • unilateral leg pain (Intensity ≥ 3)
  • 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;
  • systemic diseases;
  • malignancy
  • being in litigation or in work-compensation due to back and/or leg pain
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01954199

Contacts
Contact: Giovanni E. Ferreira, PT, Master's candidate +555193073774 giovannieferreira@Hotmail.com

Locations
Brazil
Federal University of Health Sciences of Porto Alegre Not yet recruiting
Porto Alegre, Rio Grande do sul, Brazil, 90050-170
Contact: Marcelo F Silva, PT, PhD       marcelofs@ufcspa.edu.br   
Contact: Silva         
Sponsors and Collaborators
Federal University of Health Science of Porto Alegre
  More Information

No publications provided

Responsible Party: Giovanni Esteves Ferreira, Mr, Federal University of Health Science of Porto Alegre
ClinicalTrials.gov Identifier: NCT01954199     History of Changes
Other Study ID Numbers: UFCSPA, mscgiovannisecondaryid
Study First Received: September 24, 2013
Last Updated: September 2, 2014
Health Authority: Brazil: Ethics Committee

Keywords provided by Federal University of Health Science of Porto Alegre:
Sciatica
Nerve pain
Low back pain

Additional relevant MeSH terms:
Low Back Pain
Back Pain
Signs and Symptoms
Nervous System Diseases
Sciatica
Peripheral Nervous System Diseases
Peripheral Nerve Injuries
Pain
Neurologic Manifestations
Neuralgia
Sciatic Neuropathy
Mononeuropathies
Neuromuscular Diseases
Trauma, Nervous System
Wounds and Injuries

ClinicalTrials.gov processed this record on September 16, 2014