Comparison of Neural Mobilization Techniques to Standard Care Treatment in Patients With Lumbar Radiculitis

Effectiveness of Neural Mobilization Techniques Compared to Standard Care Treatment in Patients With Lumbar Radiculitis: A Randomized Clinical Trial

The purpose of this study is to determine the effectiveness of neural mobilization techniques compared to standard care treatment in patients with lumbar radiculitis.

Study Overview

• Status: Unknown
• Conditions: Radiculitis
• Intervention / Treatment: Other: Neural Mobilization; Other: Standard Care

Detailed Description

Background:

Radicular pain has been regarded as a distinct pain entity as its pathophysiology differs from that of somatic referred pain and nociceptive pain. Radicular lumbar pain describes sensitized nerve roots of the lumbar spine or peripheral nerve trunks that are capable of producing pain (usually below the knee) and/or other symptoms in the absence of true nerve tissue damage. This type of pain is evoked by ectopic discharges stemming from lumbar dorsal roots or their ganglions. The most common causes for this type of pain is the inflammatory environment that is produced by substances contained in the herniated material of injured lumbar intervertebral discs.

It has been suggested that patients presenting with functional (e.g. mechanosensitivity) but not structural nerve root problems, can be identified through screening and further classified as a discrete group of patients that benefit from specific neural mobilization techniques.

Neural mobilization techniques have gained considerable amount of attention amongst therapists and researchers for the assessment and treatment of painful conditions that occasionally involve a neural element in their pathophysiology such as lumbar radicular pain. Studies exploring the effect of neural mobilization techniques on patients with lumbar radicular pain have generally shown good results but they are lacking in adequate sample size and methodological quality.

The aim of this study is to compare the effectiveness of neural mobilization techniques to standard care physiotherapy treatment (ultrasound, general exercises, massage therapy, transcutaneous electrical nerve stimulation) in patients with lumbar radiculitis.

Participants:

Patients with low back pain that radiates to the lower limb.

Patients that satisfy the inclusion criteria will be screened and classified by another researcher into the distinct group of lumbar radiculitis. Another researcher will take baseline measurements and all patients of this sub-group will be randomly assigned to receive either neural mobilization or standard care physiotherapy treatment. Both groups will receive a total of 10 treatments twice per week for 5 weeks. Patients will be assessed using specific outcome measures prior to treatment (baseline), at 5 weeks (post treatment) and 6 months after treatment.

Statistical analysis:

Data will be analysed with the Statistical Package for the Social Sciences (SPSS), version 22. Intension to treat analysis will be applied. A two-way mixed-model analysis of variance will be used for outcome measures, with treatment groups (neural mobilization or standard care treatment) as the between-subject variable and time (baseline, 1 month follow up, six months follow up) as the within-subject variable. Comparison of baseline demographic characteristics will be analysed using the t-tests for continuous variables and the chi square tests for categorical variables.

• Study Type: Interventional
• Enrollment (Anticipated): 130
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Michalis Efstathiou, MSc; Phone Number: +35799931840; Email: efstathiou.m@unic.ac.cy
• Study Contact Backup: Name: Manos Stefanakis, PhD; Phone Number: +35796418779; Email: stefanakis.m@unic.ac.cy

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 75 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• Patients with low back pain and pain that radiates in the lower limb
• Duration of symptoms > 6 weeks
• Patients willing to be reassessed after 6 months
• Patients willing to give written informed consent

Exclusion Criteria:

• History of spinal surgery
• History of surgery or injury in the lower limbs in the past 6 months
• Signs and symptoms of central nervous system involvement
• Nerve root blocks for the past 6 weeks
• History of diabetes
• History of polyneuropathies
• History of vascular pathologies in the lower limbs
• History of systemic pathologies
• History of inflammatory arthropathies

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Neural Mobilization Group; Patients in this group will be treated with neural mobilization techniques.	Other: Neural Mobilization; Neural mobilization techniques aimed at the lumbar root that is affected
Experimental: Standard Care Group; Patients in this group will be treated with standard care (ultrasound, exercise, TENS, massage)	Other: Standard Care; Ultrasound - Transcutaneous electrical nerve stimulation (TENS) - Massage therapy - Strengthening exercises

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Visual Analogue Scale (VAS) - Measure assessing change	The VAS is a 100-point pain assessment scale ranging from 0 (no pain) to 100 (worst pain possible).	Change from baseline after 5 weeks and at 6 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Roland Morris Disability Questionnaire (RMDQ) - Measure assessing change	The questioner measures the level of patients' disability.	Change from baseline after 5 weeks and at 6 months
Fear Avoidance and Beliefs Questionnaire (FABQ) - Measure assessing change	The questioner evaluates fear-avoidance beliefs of patients with low back pain in the clinical setting.	Change from baseline after 5 weeks and at 6 months
Handheld dynamometer - Measure assessing change	Changes in Muscle Strength assessed with the handheld dynamometer	Change from baseline after 5 weeks and at 6 months

Collaborators and Investigators

• Sponsor: Michalis Efstathiou
• Investigators: Principal Investigator: Michalis Efstathiou, MSc, University of Nicosia

Publications and helpful links

General Publications

• Schafer A, Hall T, Muller G, Briffa K. Outcomes differ between subgroups of patients with low back and leg pain following neural manual therapy: a prospective cohort study. Eur Spine J. 2011 Mar;20(3):482-90. doi: 10.1007/s00586-010-1632-2. Epub 2010 Dec 1.

Study record dates

Study Major Dates

• Study Start (Anticipated): September 1, 2017
• Primary Completion (Anticipated): March 1, 2020
• Study Completion (Anticipated): March 1, 2020

Study Registration Dates

• First Submitted: October 19, 2016
• First Submitted That Met QC Criteria: October 20, 2016
• First Posted (Estimate): October 21, 2016

Study Record Updates

• Last Update Posted (Actual): May 5, 2017
• Last Update Submitted That Met QC Criteria: May 2, 2017
• Last Verified: May 1, 2017

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Nervous System Diseases; Neuromuscular Diseases; Peripheral Nervous System Diseases; Radiculopathy
• Other Study ID Numbers: MISS13

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: Undecided

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No