Lumbar Spinal StenosisNCT06407167
Neuropathic Pain in Patients With Degenerative Lumbar Stenosis
An observational study of Lumbar Spinal Stenosis and Neuropathic Pain, run by N.N. Priorov National Medical Research Center of Traumatology and Orthopedics at 1 site in Russia.
Trial summary
Pre- and postoperative pain in patients with degenerative stenosis requires great attention, as it can mislead the doctor about treatment tactics. Neuropathic pain in the legs before and after the surgical procedure, as well as the residual or recurrent pain syndrome existing against this background, overshadow the… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Lumbar Spinal Stenosis, Neuropathic Pain, Spinal Disease
- What is being tested?
- DN4 (Douleur Neuropathique 4 Questions) questionnaire
- How many people
- 147 participants
- Where
- 1 siteRussia
- Study dates
- 13 May 2024to 1 Jul 2026
- Phase
- Observational
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: One study center in Russia will include adult patients with radicular leg pain with/without neurogenic claudication with/without back pain caused by degenerative spinal stenosis with MRI-confirmed nerve compression; with symptoms persisting for more than 3 months before surgery.
Who may be able to join
- Age 18-85 years;
- Radicular leg pain with or without neurogenic claudication with or without back pain;
- Planned decompressive surgery for degenerative lumbar stenosis with or without degenerative spondylolisthesis;
- Symptoms persisting for at least 3 months prior to surgery;
- Given written Informed Consent;
- Able and agree to fully comply with the clinical protocol and willing to adhere to follow-up schedule and requirements
Who cannot join
- Prior lumbar fusion at any level;
- Any contraindication or inability to undergo baseline and/or follow up MRI or X-ray as required per protocol;
- Back or non-radicular pain of unknown etiology;
- History or presence of any other major neurological disease or condition that may interfere with the study assessments (e.g. significant peripheral neuropathy, multiply sclerosis);
- Any other condition or situation that the investigator believes may interfere with the safety of the subject or the intent and conduct of the study;
- Previous enrollment in this study, current enrollment or plans to be enrolled in another study (in parallel to this study).
Trial locations and contacts
1 site in 1 country.
Russia1 site
Priorov National Medical Research Center of Traumatology and Orthopedics
Moscow, 127299
About this study
Official title: Observational Cohort Study of the Neuropathic Pain in Surgical Treatment of Patients With Degenerative Lumbar Stenosis
Pre- and postoperative pain in patients with degenerative stenosis requires great attention, as it can mislead the doctor about treatment tactics. Neuropathic pain in the legs before and after the surgical procedure, as well as the residual or recurrent pain syndrome existing against this background, overshadow the patient's recovery and cast doubt on the fullness of the performed decompression. Neural compression in the spinal canal and back pain may be the cause of the patient's antalgic posture and sagittal imbalance as seen on X-Ray, to need for corrective interventions surgical procedure.
Thus, it is necessary to clarify the role and the influence of the pain and its type on the perioperative period in patients with degenerative lumbar spinal stenosis.
Read the detailed description
The current study is prospective observational study to evaluate the role of pain syndrome including neuropathic pain in surgical outcomes in patients with degenerative lumbar spinal stenosis.
This study will be conducted at Priorov Central Institute for Trauma and Orthopedics, Moscow, Russia.
The study is expected to enroll at least 120 adult patients with degenerative lumbar stenosis. The neuropathy will be assessed preoperatively, and then the patient will undergo decompressive lumbar surgery without fusion.
The neuropathic pain will be evaluated according to DN4 preoperatively, each patient will be assigned to one of two groups depending on the total value of DN4 - with the presence of neuropathy (DN4>= 4) and without neuropathy (DN4 <4).
Postoperative evaluation will include 2 visits during one year to evaluate clinical and radiological outcomes.
- Conditions
- Lumbar Spinal Stenosis, Neuropathic Pain, Spinal Disease
- Being tested
- DN4 (Douleur Neuropathique 4 Questions) questionnaire
- Medical subject headings
- Spinal Stenosis, Neuralgia, Spinal Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
DN4 (Douleur Neuropathique 4 Questions) questionnaireDiagnostic test
Also called neuropathic pain diagnostic questionnaire
DN4 includes a series of ten questions consisting of both sensory descriptors and signs related to bedside sensory examination
| Study group | Role | What they receive |
|---|---|---|
| Neuropathic Pain | All patients will undergo lumbar decompression at stenosis levels (clinically and MRI confirmed) regardless of study group Receives: Diagnostic Test: DN4 (Douleur Neuropathique 4 Questions) questionnaire | |
| No Neuropathic Pain | All patients will undergo lumbar decompression at stenosis levels (clinically and MRI confirmed) regardless of study group Receives: Diagnostic Test: DN4 (Douleur Neuropathique 4 Questions) questionnaire |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change from baseline in Oswestry Disability Index (ODI)
To observe the change of Oswestry Disability Index as compared to baseline through follow-up terms
Measured: 3 months postoperatively
Secondary outcomes (8)
Change from baseline in Neuropathic Pain 4 Questions (DN4)
To observe the change of Neuropathic Pain 4 Questions as compared to baseline through follow-up terms
Measured: 2 weeks (or at day of hospital discharge), 3 months, 12 months postoperatively
Change from baseline in Numeric Pain Rating Scale (NPRS)
To observe the change of Numeric Pain Rating Scale as compared to baseline through follow-up terms
Measured: 2 weeks (or at day of hospital discharge), 3 months, 12 months postoperatively
Change from baseline in Oswestry Disability Index (ODI)
To observe the change of Oswestry Disability Index as compared to baseline through follow-up terms
Measured: 12 months postoperatively
Change from baseline in The Health Transition Item from SF-36 (HTI Item)
To observe the change of The Health Transition Item as compared to baseline through follow-up terms
Measured: 2 weeks (or at day of hospital discharge), 3 months, 12 months postoperatively
Change from baseline in sagittal balance parameters
To observe the change of sagittal balance parameters (index Barrey) as compared to baseline through follow-up terms
Measured: 3 months, 12 months postoperatively
Change from baseline in regional balance parameters
To observe the change of regional balance parameters (Segmental Lordosis) as compared to baseline through follow-up terms
Measured: 3 months, 12 months postoperatively
Change from baseline in frontal balance parameters
To observe the change of frontal balance parameters (Cobb's angle) as compared to baseline through follow-up terms
Measured: 3 months, 12 months postoperatively
the safety parameters
To observe and document the safety parameters (Adverse events)
Measured: during study, an average of 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 May 2024
- Study start13 May 2024
- Primary completion16 May 2025
- Study completion1 Jul 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Lumbar Spinal StenosisStudies 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 147 participants (actual)
Sponsor and investigators
- Lead sponsor
- N.N. Priorov National Medical Research Center of Traumatology and Orthopedics
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Aleksandr Krutko, N.N. Priorov National Medical Research Center of Traumatology and Orthopedics
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06407167
- Sponsor's protocol ID
- NS12-02
- Status last verified
- Jul 2026
- First submitted
- 24 Apr 2024
- Last updated
- 27 Oct 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 27 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Observational Cohort Study of the Neuropathic Pain in Surgical Treatment of Patients With Degenerative Lumbar Stenosis
- ClinicalTrials.gov ID
- NCT06407167
- Acronym / sponsor ID
- NS12-02
- Conditions
- Lumbar Spinal Stenosis, Neuropathic Pain, Spinal Disease
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 147 participants (actual)
- Lead sponsor
- N.N. Priorov National Medical Research Center of Traumatology and OrthopedicsUniversity, hospital or other
- Study start
- 13 May 2024 (actual)
- Primary completion
- 16 May 2025 (actual)
- Study completion
- 1 Jul 2026 (actual)
- First posted
- 9 May 2024 (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.
Pre- and postoperative pain in patients with degenerative stenosis requires great attention, as it can mislead the doctor about treatment tactics. Neuropathic pain in the legs before and after the surgical procedure, as well as the residual or recurrent pain syndrome existing against this background, overshadow the patient's recovery and cast doubt on the fullness of the performed decompression. Neural compression in the spinal canal and back pain may be the cause of the patient's antalgic posture and sagittal imbalance as seen on X-Ray, to need for corrective interventions surgical procedure.
Thus, it is necessary to clarify the role and the influence of the pain and its type on the perioperative period in patients with degenerative lumbar spinal stenosis.
Detailed description
The current study is prospective observational study to evaluate the role of pain syndrome including neuropathic pain in surgical outcomes in patients with degenerative lumbar spinal stenosis.
This study will be conducted at Priorov Central Institute for Trauma and Orthopedics, Moscow, Russia.
The study is expected to enroll at least 120 adult patients with degenerative lumbar stenosis. The neuropathy will be assessed preoperatively, and then the patient will undergo decompressive lumbar surgery without fusion.
The neuropathic pain will be evaluated according to DN4 preoperatively, each patient will be assigned to one of two groups depending on the total value of DN4 - with the presence of neuropathy (DN4>= 4) and without neuropathy (DN4 <4).
Postoperative evaluation will include 2 visits during one year to evaluate clinical and radiological outcomes.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Neuropathic Pain | – | Diagnostic Test: DN4 (Douleur Neuropathique 4 Questions) questionnaireAll patients will undergo lumbar decompression at stenosis levels (clinically and MRI confirmed) regardless of study group |
| No Neuropathic Pain | – | Diagnostic Test: DN4 (Douleur Neuropathique 4 Questions) questionnaireAll patients will undergo lumbar decompression at stenosis levels (clinically and MRI confirmed) regardless of study group |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- One study center in Russia will include adult patients with radicular leg pain with/without neurogenic claudication with/without back pain caused by degenerative spinal stenosis with MRI-confirmed nerve compression; with symptoms persisting for more than 3 months before surgery.
Key inclusion criteria (6 listed)
- Age 18-85 years;
- Radicular leg pain with or without neurogenic claudication with or without back pain;
- Planned decompressive surgery for degenerative lumbar stenosis with or without degenerative spondylolisthesis;
- Symptoms persisting for at least 3 months prior to surgery;
- Given written Informed Consent;
Key exclusion criteria (6 listed)
- Prior lumbar fusion at any level;
- Any contraindication or inability to undergo baseline and/or follow up MRI or X-ray as required per protocol;
- Back or non-radicular pain of unknown etiology;
- History or presence of any other major neurological disease or condition that may interfere with the study assessments (e.g. significant peripheral neuropathy, multiply sclerosis);
- Any other condition or situation that the investigator believes may interfere with the safety of the subject or the intent and conduct of the study;
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 |
|---|---|---|
| DN4 (Douleur Neuropathique 4 Questions) questionnaireAlso: neuropathic pain diagnostic questionnaireDN4 includes a series of ten questions consisting of both sensory descriptors and signs related to bedside sensory examination | Diagnostic test | Neuropathic Pain, No Neuropathic Pain |
Primary outcome
Change from baseline in Oswestry Disability Index (ODI)
Time frame: 3 months postoperatively
To observe the change of Oswestry Disability Index as compared to baseline through follow-up terms
8 secondary outcomes
Change from baseline in Neuropathic Pain 4 Questions (DN4)
Time frame: 2 weeks (or at day of hospital discharge), 3 months, 12 months postoperatively
Change from baseline in Numeric Pain Rating Scale (NPRS)
Time frame: 2 weeks (or at day of hospital discharge), 3 months, 12 months postoperatively
Change from baseline in Oswestry Disability Index (ODI)
Time frame: 12 months postoperatively
Change from baseline in The Health Transition Item from SF-36 (HTI Item)
Time frame: 2 weeks (or at day of hospital discharge), 3 months, 12 months postoperatively
Change from baseline in sagittal balance parameters
Time frame: 3 months, 12 months postoperatively
Change from baseline in regional balance parameters
Time frame: 3 months, 12 months postoperatively
Change from baseline in frontal balance parameters
Time frame: 3 months, 12 months postoperatively
the safety parameters
Time frame: during study, an average of 1 year
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 27 Oct 2026.
- Individual participant dataSharing planned: No
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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?
An observational study of Lumbar Spinal Stenosis and Neuropathic Pain, run by N.N. Priorov National Medical Research Center of Traumatology and Orthopedics at 1 site in Russia.
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 6 inclusion and 6 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 27 Oct 2026. 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 Russia. 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?
Change from baseline in Oswestry Disability Index (ODI) (time frame: 3 months postoperatively). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 27 Oct 2026.