Comment Period Extended to 3/23/2015 for Notice of Proposed Rulemaking (NPRM) for FDAAA 801 and NIH Draft Reporting Policy for NIH-Funded Trials
Text Size

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 February 2015 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: February 11, 2015
Last verified: February 2015
History of Changes
  Purpose

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


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:

U.S. FDA Resources

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 a 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 a 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)

  • Back pain intensity [ Time Frame: Two weeks after randomization ] [ Designated as safety issue: No ]
    Back Pain will me measured by an 0-10 Pain NRS

  • Back pain intensity [ Time Frame: Four weeks after randomization ] [ Designated as safety issue: No ]
    Back Pain will me measured by an 0-10 Pain NRS

  • 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
Estimated Enrollment: 60
Study Start Date: April 2015
Estimated Study Completion Date: June 2016
Estimated Primary Completion Date: April 2016 (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.

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.

  Eligibility
Ages Eligible for Study:   18 Years to 80 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  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
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
  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
Study First Received: September 24, 2013
Last Updated: February 11, 2015
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:
Nervous System Diseases
Peripheral Nerve Injuries
Peripheral Nervous System Diseases
 Neuromuscular Diseases
Trauma, Nervous System
Wounds and Injuries

ClinicalTrials.gov processed this record on March 03, 2015