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

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
32

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • 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

  • Spain
    • 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

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

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

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
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.
Other: Motor Control Exercises
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).
Other: 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).

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
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

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
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.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Universidad Rey Juan Carlos

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.

General Publications

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)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
August 10, 2018

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
October 3, 2018

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
December 5, 2018

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
July 24, 2018

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
August 6, 2018

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
August 8, 2018

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
December 17, 2018

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
December 13, 2018

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
December 1, 2018

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant 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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