The Effectiveness of Lower Limb Neurodynamic Techniques on Pain and Disability in Subjects With Lower Limb Radicular Pain

This study is not yet open for participant recruitment. (see Contacts and Locations)
Verified September 2013 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 26, 2013
Last verified: September 2013
  Purpose

Low back-related leg pain (LBRLP), although less prevalent than low back pain itself, is associated with higher economic and social burden, and consists in 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 nerve trunk pain. In light of this, many techniques are described for the management of the dysfunctions of the sciatic nerve.

Thus, this study aims to verify, through a randomized sham-controlled trial, the effectiveness of a single application of neurodynamic techniques on pain and disability in individuals with LBRLP.


Condition Intervention
Radicular Pain
Sciatica
Entrapment Neuropathies
Procedure: neurodynamic
Procedure: Sham-neurodynamics

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Immediate Effects of Neurodynamic Techniques on Pain and Pressure Pain Thresholds in Subjects With Back-related Leg Pain: a Randomized Sham-controlled Trial

Resource links provided by NLM:


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

Primary Outcome Measures:
  • Pain (numeric pain rating scale) [ Time Frame: Immediate ] [ Designated as safety issue: No ]
    Immediately after the intervention, the subjects will be asked about their post-treatment pain scores in the symptomatic leg and in the back, which will be measured with the numeric pain rating scale (NPRS). Pain will be assessed with individuals at rest

  • Pain (Numeric Pain Rating Scale) [ Time Frame: 1 week ] [ Designated as safety issue: No ]
    1 week after the intervention, the subjects will be asked about their current pain scores in the symptomatic leg and in the back, which will be measured with the numeric pain rating scale (NPRS). Pain will be assessed with individuals at rest.


Secondary Outcome Measures:
  • Straight leg raise range of motion [ Time Frame: Immediate ] [ Designated as safety issue: No ]
    With subjects lying in prone, an inclinometer will be positioned in the symptomatic (and therefore the treated) leg immediately after the intervention. Then, they will be instructed to raise their leg straightly. The mean range of motion (ROM) of 3 measures will be recorded.

  • Oswestry Disability Index [ Time Frame: 1 week ] [ Designated as safety issue: No ]
    One week after the intervention, individuals will be asked to complete the Oswestry Disability Index (ODI), which is a self-reported questionnaire that addresses functional restrictions in subjects with low back pain. This questionnaire is widely used, with good psychometric properties and excellent responsiveness and is also used in individuals with back-related leg pain.


Estimated Enrollment: 40
Study Start Date: August 2014
Estimated Study Completion Date: March 2016
Estimated Primary Completion Date: January 2016 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Neurodynamic group
In this arm, the individuals allocated will receive neurodynamic techniques, applied according to the results of the physical examination
Procedure: neurodynamic
The joints are positioned in such a way that allows the therapist to promote stress on nerve tissue. The mechanical stress imposed to this tissue is capable of elicit physiological responses that generate hypoalgesic effects.
Other Names:
  • neural mobilization
  • sliders
  • tensioners
Sham Comparator: sham-neurodynamic Procedure: Sham-neurodynamics
The individuals allocated to this intervention will receive sham-neurodynamic techniques; i.e, techniques that only simulate a neurodynamic approach without necessarily generating treatment effects
Other Names:
  • sham-neural mobilization
  • sham-neural sliders

  Eligibility

Ages Eligible for Study:   40 Years to 80 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • have a neural response with abnormal findings; be able to understand and write in portuguese; both genders; age between 40-80 years

Exclusion Criteria:

  • systemic illness; diabetes; malignancy; cognitive impairment;
  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 +5193073774 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: Giovanni E. Ferreira, PT    +5193073774    giovannieferreira@Hotmail.com   
Contact: Marcelo F. Silva, PhD         
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 26, 2013
Health Authority: Brazil: The Federal University of Health Sciences of Porto Alegre

Keywords provided by Federal University of Health Science of Porto Alegre:
Radicular pain
Sciatica
Entrapment neuropathies

Additional relevant MeSH terms:
Charcot-Marie-Tooth Disease
Nerve Compression Syndromes
Nervous System Diseases
Heredodegenerative Disorders, Nervous System
Neurodegenerative Diseases
Peripheral Nervous System Diseases
Neuromuscular Diseases
Genetic Diseases, Inborn
Hereditary Sensory and Motor Neuropathy
Sciatica
Nervous System Malformations
Polyneuropathies
Congenital Abnormalities
Neuralgia
Pain
Neurologic Manifestations
Sciatic Neuropathy
Mononeuropathies
Signs and Symptoms

ClinicalTrials.gov processed this record on August 28, 2014