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

Study Status: Completed
Recruit Status: Completed
Study Type: Interventional

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

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

Detailed Summary:

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.

Sponsor: Federal University of Health Science of Porto Alegre

Current Primary Outcome:

• Leg Pain Intensity [ Time Frame: Two weeks after randomization ]
  Leg Pain will be measured by a 0-10 Numeric Rating Scale (Pain NRS)
• Disability [ Time Frame: Two weeks after randomization ]
  Disability will be measured by the Oswestry Disability Index (ODI)

Original Primary Outcome:

• Pain (numeric pain rating scale) [ Time Frame: Immediate ]
  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 ]
  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.

Current Secondary Outcome:

• Leg pain Intensity [ Time Frame: Four weeks after randomization ]
  Leg Pain will me measured by a 0-10 Pain NRS
• Disability [ Time Frame: Four weeks after randomization ]
  Disability will be measured by the Oswestry Disability Index (ODI)
• Back pain intensity [ Time Frame: Two weeks after randomization ]
  Back Pain will me measured by an 0-10 Pain NRS
• Back pain intensity [ Time Frame: Four weeks after randomization ]
  Back Pain will me measured by an 0-10 Pain NRS
• Distribution of Symptoms [ Time Frame: Two weeks, Four weeks after randomization ]
  Distribution of symptoms will me measured by a body diagram
• Function [ Time Frame: Two weeks, Four weeks after randomization ]
  Function will be measured by the Patient-Specific Functional Scale (PSFS)
• Global Perceived Effect [ Time Frame: Two weeks, Four weeks after randomization ]
  Global Perceived Effect will be measured by an 11-point (-5 to +5) Global Perceived Effect Scale

Original Secondary Outcome:

• Straight leg raise range of motion [ Time Frame: Immediate ]
  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 ]
  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.

Information By: Federal University of Health Science of Porto Alegre

Dates:
Date Received: September 24, 2013
Date Started: March 2015
Date Completion:
Last Updated: June 1, 2016
Last Verified: June 2016