Neurodynamic Intervention for Lumbar Radiculopathy

December 13, 2018 updated by: César Fernández-de-las-Peñas, Universidad Rey Juan Carlos

Motor Control Exercises and Neurodynamic Intervention for Lumbar Radiculopathy: A Randomized Clinical Trial

Low back pain (LBP) is a common condition and has a significant impact on the individual in terms of pain and disability. Lumbar radiculopathy occurs often with LBP and may be the result of a lumbar herniated disc which will irritate a lumbar nerve trunk resulting in intraneural inflammation. There is evidence supporting the use of manual therapies of lumbar radiculopathy. One potential manual therapy is neurodynamic mobilization technique. No scientific evidence, based on a RCT, exists that this particular approach is beneficial for individuals with LBP and lumbar radiculopathy

Study Overview

Study Type

Interventional

Enrollment (Actual)

32

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

    • Madrid
      • Alcorcon, Madrid, Spain, 28922
        • Universidad Rey Juan Carlos

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 65 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Subjects with a confirmed (via MRI) disc herniation at between L4 and S1 level;
  • Subjects exhibiting lumbar radiating pain in the lower extremity for at least 3 months
  • Subjects with a positive straight leg raise with symptoms reproduction

Exclusion Criteria:

  • indication for surgical intervention;
  • had a confirmed disc herniation at other lumbar levels;
  • have had any other spinal conditions such as spinal tumors or spondylolisthesis;
  • had received treatment for this condition by a physical therapist the previous 6 month;
  • pregnancy

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

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

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: Motor control exercise
Patients will receive 8 sessions of motor control exercise program of 30 min duration for 4 weeks, twice per week. Exercises will be demonstrated to the participants by an experienced physical therapist. On each session, the therapist will correct each subject personally. Participants will be asked for practicing the exercises at home once daily for 20 minutes over the 8-week intervention period. The motor control exercise program will consist of a progression from isolated contraction of the transversus abdominis and/or isolated contraction of the multifidi to combined contraction of both transversus abdominis in different positions from supine or prone to bridging or four-point kneeling.
Patients will receive 8 sessions of motor control exercise program of 30 min duration for 4 weeks, twice per week. Exercises will be demonstrated to the participants by an experienced physical therapist. On each session, the therapist will correct each subject personally. Participants will be asked for practicing the exercises at home once daily for 20 minutes over the 8-week intervention period. The motor control exercise program will consist of a progression from isolated contraction of the transversus abdominis and/or isolated contraction of the multifidi to combined contraction of both transversus abdominis in different positions from supine or prone to bridging or four-point kneeling.
Experimental: Motor control exercise plus neurodynamic intervention
Patients will receive 8 sessions of motor control exercise program of 30 min duration for 4 weeks, twice per week. Exercises will be demonstrated to the participants by an experienced physical therapist. On each session, the therapist will correct each subject personally. Participants will be asked for practicing the exercises at home once daily for 20 minutes over the 8-week intervention period. The motor control exercise program will consist of a progression from isolated contraction of the transversus abdominis and/or isolated contraction of the multifidi to combined contraction of both transversus abdominis in different positions from supine or prone to bridging or four-point kneeling. In addition, participants allocated to the neurodynamic group will also receive a nerve neurodynamic slider intervention targeting the main trunk of the sciatic nerve of the affected side during al treatment sessions (n=8).
Patients will receive 8 sessions of motor control exercise program of 30 min duration for 4 weeks, twice per week. Exercises will be demonstrated to the participants by an experienced physical therapist. On each session, the therapist will correct each subject personally. Participants will be asked for practicing the exercises at home once daily for 20 minutes over the 8-week intervention period. The motor control exercise program will consist of a progression from isolated contraction of the transversus abdominis and/or isolated contraction of the multifidi to combined contraction of both transversus abdominis in different positions from supine or prone to bridging or four-point kneeling. In addition, participants allocated to the neurodynamic group will also receive a nerve neurodynamic slider intervention targeting the main trunk of the sciatic nerve of the affected side during al treatment sessions (n=8).

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Changes in Lower Extremity Pain Intensity
Time Frame: Baseline, after 4 treatment sessions, after 8 treatment sessions,and 2 months after last treatment session
A Numerical Pain Rate Scale (NPRS, 0-10) where 0 represents no pain and 10 the maximum pain will be used to record the mean intensity of pain in the lower extremity
Baseline, after 4 treatment sessions, after 8 treatment sessions,and 2 months after last treatment session

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Changes in Neuropathic Mechanism Consideration
Time Frame: Baseline, after 4 treatment sessions, after 8 treatment sessions,and 2 months after last treatment session
The Self-report Leeds Assessment of Neuropathic Symptoms and Signs Scale (S-LANSS) will be used for assessing neuropathic mechanism. The S-LANSS is a 7-item tool for identifying patients whose pain is dominated by neuropathic mechanisms. Each item is a binary response (yes or no) to the presence of symptoms (5 items) or clinical signs (2 items). The total score is 24 points and a value ≥ 12 points is indicative of a neuropathic component of pain.
Baseline, after 4 treatment sessions, after 8 treatment sessions,and 2 months after last treatment session
Changes in Related-Disability
Time Frame: Baseline, after 4 treatment sessions, after 8 treatment sessions,and 2 months after last treatment session
The Roland-Morris Disability Questionnaire will be used for assessing related-disability. The score can range from 0-24 with higher scores indicative of higher related-disability.
Baseline, after 4 treatment sessions, after 8 treatment sessions,and 2 months after last treatment session
Changes in Mechanical Sensitivity of the Sciatic Nerve
Time Frame: Baseline, after 4 treatment sessions, after 8 treatment sessions,and 2 months after last treatment session
The degrees of the straight leg raise test will be used to assess sensitivity of the sciatic nerve
Baseline, after 4 treatment sessions, after 8 treatment sessions,and 2 months after last treatment session
Changes in Pressure Pain Thresholds
Time Frame: Baseline, after 4 treatment sessions, after 8 treatment sessions,and 2 months after last treatment session
Pressure pain thresholds will be assessed with a mechanical algometer over the common peroneal and tibial nerve
Baseline, after 4 treatment sessions, after 8 treatment sessions,and 2 months after last treatment session

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

August 10, 2018

Primary Completion (Actual)

October 3, 2018

Study Completion (Actual)

December 5, 2018

Study Registration Dates

First Submitted

July 24, 2018

First Submitted That Met QC Criteria

August 6, 2018

First Posted (Actual)

August 8, 2018

Study Record Updates

Last Update Posted (Actual)

December 17, 2018

Last Update Submitted That Met QC Criteria

December 13, 2018

Last Verified

December 1, 2018

More Information

Terms related to this study

Other Study ID Numbers

  • HU201531

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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