Lumbar RadiculopathyNCT03620864
Neurodynamic Intervention for Lumbar Radiculopathy
A study of Lumbar Radiculopathy, run by Universidad Rey Juan Carlos at 1 site in Spain.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Lumbar Radiculopathy
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 32 participants
- Where
- 1 siteSpain
- Study dates
- 10 Aug 2018to 5 Dec 2018
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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
- Conditions
- Lumbar Radiculopathy
- Being tested
- Motor Control Exercises, Motor Control Exercise Plus Neurodynamic Intervention
- Medical subject headings
- Radiculopathy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Motor Control ExercisesOther
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.
Motor Control Exercise Plus Neurodynamic InterventionOther
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).
| Study group | Role | What they receive |
|---|---|---|
| Motor control exercise | Active comparator | 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. Receives: Other: Motor Control Exercises |
| Motor control exercise plus neurodynamic intervention | Experimental | 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). Receives: Other: Motor Control Exercise Plus Neurodynamic Intervention |
What is being measured
The primary outcome is the main question the study is designed to answer.
Changes in Lower Extremity Pain Intensity
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
Measured: Baseline, after 4 treatment sessions, after 8 treatment sessions,and 2 months after last treatment session
Secondary outcomes (4)
Changes in Neuropathic Mechanism Consideration
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.
Measured: Baseline, after 4 treatment sessions, after 8 treatment sessions,and 2 months after last treatment session
Changes in Related-Disability
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.
Measured: Baseline, after 4 treatment sessions, after 8 treatment sessions,and 2 months after last treatment session
Changes in Mechanical Sensitivity of the Sciatic Nerve
The degrees of the straight leg raise test will be used to assess sensitivity of the sciatic nerve
Measured: Baseline, after 4 treatment sessions, after 8 treatment sessions,and 2 months after last treatment session
Changes in Pressure Pain Thresholds
Pressure pain thresholds will be assessed with a mechanical algometer over the common peroneal and tibial nerve
Measured: Baseline, after 4 treatment sessions, after 8 treatment sessions,and 2 months after last treatment session
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Aug 2018
- Study start10 Aug 2018
- Primary completion3 Oct 2018
- Study completion5 Dec 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Lumbar RadiculopathyStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 32 participants (actual)
Sponsor and investigators
- Lead sponsor
- Universidad Rey Juan Carlos
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, César Fernández-de-las-Peñas, Universidad Rey Juan Carlos
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03620864
- Sponsor's protocol ID
- HU201531
- Status last verified
- Dec 2018
- First submitted
- 24 Jul 2018
- Last updated
- 17 Dec 2018
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Plaza-Manzano G, Cancela-Cilleruelo I, Fernandez-de-Las-Penas C, Cleland JA, Arias-Buria JL, Thoomes-de-Graaf M, Ortega-Santiago R. Effects of Adding a Neurodynamic Mobilization to Motor Control Training in Patients With Lumbar Radiculopathy Due to Disc Herniation: A Randomized Clinical Trial. Am J Phys Med Rehabil. 2020 Feb;99(2):124-132. doi: 10.1097/PHM.0000000000001295.
PubMed 31464753
Study at a glance
From the registry record, last updated by the sponsor on 17 Dec 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Motor Control Exercises and Neurodynamic Intervention for Lumbar Radiculopathy: A Randomized Clinical Trial
- ClinicalTrials.gov ID
- NCT03620864
- Acronym / sponsor ID
- HU201531
- Conditions
- Lumbar Radiculopathy
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 32 participants (actual)
- Lead sponsor
- Universidad Rey Juan CarlosUniversity, hospital or other
- Study start
- 10 Aug 2018 (actual)
- Primary completion
- 3 Oct 2018 (actual)
- Study completion
- 5 Dec 2018 (actual)
- First posted
- 8 Aug 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Motor control exercise | Active comparator | Other: Motor Control ExercisesPatients 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. |
| Motor control exercise plus neurodynamic intervention | Experimental | Other: Motor Control Exercise Plus Neurodynamic InterventionPatients 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). |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- 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
Key exclusion criteria (5 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Motor Control ExercisesPatients 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 exercise |
| Motor Control Exercise Plus Neurodynamic InterventionPatients 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 |
Primary outcome
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
4 secondary outcomes
Changes in Neuropathic Mechanism Consideration
Time frame: 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
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
Changes in Pressure Pain Thresholds
Time frame: Baseline, after 4 treatment sessions, after 8 treatment sessions,and 2 months after last treatment session
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Dec 2018.
- Derived from this study: PubMed 31464753Plaza-Manzano G, Cancela-Cilleruelo I, Fernandez-de-Las-Penas C, Cleland JA, Arias-Buria JL, Thoomes-de-Graaf M, Ortega-Santiago R. Effects of Adding a Neurodynamic Mobilization to Motor Control Training in Patients With Lumbar Radiculopathy Due to Disc Herniation: A Randomized Clinical Trial. Am J Phys Med Rehabil. 2020 Feb;99(2):124-132. doi: 10.1097/PHM.0000000000001295.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study of Lumbar Radiculopathy, run by Universidad Rey Juan Carlos at 1 site in Spain.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 17 Dec 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Spain. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Changes in Lower Extremity Pain Intensity (time frame: Baseline, after 4 treatment sessions, after 8 treatment sessions,and 2 months after last treatment session). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03620864, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 17 Dec 2018; AzTrials last refreshed its copy on 5 Nov 2026.