- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03620864
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
Completed
Conditions
Intervention / Treatment
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.
Sponsor
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
Additional Relevant MeSH Terms
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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