Lumbar Disc HerniationLomboDNNCT06763224
Prevalence of Neuropathic Pain After Non-instrumented Lumbar Spinal Surgery
An observational study of Lumbar Disc Herniation and Lumbar Spinal Stenosis, run by Centre Hospitalier de Colmar at 1 site in France.
Trial summary
Chronic neuropathic pain following lumbar spine surgery is often under-diagnosed and difficult to relieve. It can persist long after the operation, sometimes for months or even years, and has a major impact on the quality of life of patients who suffer from it. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Lumbar Disc Herniation, Lumbar Spinal Stenosis
- What is being tested?
- Questionnaire and Physical Exam
- How many people
- 39 participants
- Where
- 1 siteFrance
- Study dates
- 1 Jul 2024to 5 Sep 2025
- 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: Primary care clinic
Who may be able to join
- Patients admitted for scheduled primary lumbar spine surgery without pedicle osteosynthesis or interbody cage.
- Pathology concerned by programmed surgery: herniated disc or lumbar spinal stenosis, uncomplicated by motor or sphincter deficits.
- Delay between 1st painful symptoms and surgery > 48h.
- Non-inclusion criteria:
- Surgery scheduled within 48 hours of onset of symptoms.
- Presence of cauda equina syndrome
Show all 12Show fewer
- Presence of motor-radicular deficit
- Patients with neurological pathology prior to surgery
- Major cognitive or sensory disorders preventing completion of the self-questionnaire
- Patients under guardianship
- Patients not covered by French social security.
- Patients who develop an identified neurological pathology after surgery, regardless of the initial surgery (e.g. multiple sclerosis, spinal cord injury, etc.).
Who cannot join
None listed.
Trial locations and contacts
1 site in 1 country.
About this study
Chronic neuropathic pain following lumbar spine surgery is often under-diagnosed and difficult to relieve. It can persist long after the operation, sometimes for months or even years, and has a major impact on the quality of life of patients who suffer from it. However, the scientific literature on the subject remains relatively poor, as evidenced by the absence of scientific studies on the prevalence of neuropathic pain after lumbar spinal surgery, whether instrumented or not.
The main aim of this study is to determine whether lumbar spine surgery has an impact on the prevalence of neuropathic pain. Participants will be followed up and complete a quality-of-life questionnaire for one year after surgery.
- Conditions
- Lumbar Disc Herniation, Lumbar Spinal Stenosis
- Being tested
- Questionnaire and Physical Exam
- Keywords
- Neuropathic pain, Lumbar spinal surgery
- Medical subject headings
- Intervertebral Disc Displacement, Spinal Stenosis, Neuralgia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Questionnaire and Physical ExamOther
The neuropathic pain measured with the Neuropathic pain DN4 Questionnaire (Echelle de la Douleur Neuropathique en 4 questions - Neuropathic Pain Scale in 4 questions) The global pain measured with Visual Analogue Scale (VAS) The patient's permanent functional disability measured with the Oswestry disability index (ODI) The quality of life measured with the questionnaire EuroQol-5 Dimension (EQ-5D-5L)
What is being measured
The primary outcome is the main question the study is designed to answer.
Comparison of the proportion of patients with neuropathic pain between the day before surgery and 12 months after surgery.
Comparison of the proportion of patients with a score ≥ 4 measured with the DN4 questionnaire one day before surgery and 12 months after surgery. The DN4 questionnaire (4-question neuropathic pain scale) is a diagnostic tool used to identify and assess neuropathic pain. The questionnaire aims to measure the presence of symptoms and signs commonly associated with neuropathic pain.
The questionnaire comprises 10 items:
- 7 items relate to the patient's description of his or her pain (burning, painful cold, electric shocks, tingling, numbness, itching).
- 3 items are based on the clinician's sensory examination, focusing on touch and pinprick hypoesthesia, as well as brush-induced allodynia.
The DN4 is scored out of 10 points. A score of 4 or more suggests the presence of neuropathic pain.
Measured: The day before surgery and 12 months after surgery
Secondary outcomes (4)
Evolution of post-operative neuropathic pain
Proportion of patients with a DN4 score ≥ 4 at 1, 3 and 6 months post-operatively.
The DN4 questionnaire (4-question neuropathic pain scale) is a diagnostic tool used to identify and assess neuropathic pain. The questionnaire aims to measure the presence of symptoms and signs commonly associated with neuropathic pain.
The questionnaire comprises 10 items:
- 7 items relate to the patient's description of his or her pain (burning, painful cold, electric shocks, tingling, numbness, itching).
- 3 items are based on the clinician's sensory examination, focusing on touch and pinprick hypoesthesia, as well as brush-induced allodynia.
Measured: At 1, 3 and 6 months after surgery
Evolution of overall pain
Global pain is measured using the Visual Analog Scale (VAS). The VAS is one of a number of pain assessment scales. Using a ruler, the score is determined by measuring the distance in mm on a 10 cm line between the "no pain" reference point and the patient's mark, giving a range of scores from 0 to 100. A higher score indicates greater pain intensity.
Measured: The day before surgery and at 1, 3, 6 and 12 months after surgery
Evolution of functionality and disability of patients
The Oswestry Disability Index (ODI) is used to measure a patient's permanent functional disability. The ODI consists of 10 questions, scored from 0 to 5 (minimum to maximum). The total points for each section are added together, divided by the total possible points for all completed sections, and multiplied by 100 to create a disability percentage from 0 to 100%. A high percentage indicates significant disability.
Measured: The day before surgery and at 1, 3, 6 and 12 months after surgery
Evolution of quality of life measured with EQ-5D-5L
The EuroQoL-5D-5L (EQ-5D-5L) self-administered questionnaire comprises 2 pages: one page with the 5-dimensional questionnaire EQ-5D and the visual analog quality-of-life scale EQ VAS. The EQ-5D explores the following 5 dimensions: mobility, personal care, usual activities, pain/discomfort and anxiety/depression. Each dimension has five levels: no problems, mild problems, moderate problems, severe problems and extreme problems. Patients are asked to indicate their state of health by ticking the box corresponding to the most appropriate statement in each of the five dimensions. The level chosen for each dimension corresponds to 1 number from 1 to 5 (1 = no problems, 5 = extreme problems).
The VAS EQ records the patient's self-assessment of health status on a vertical visual analogue scale, the ends of which are entitled "The best health you can imagine" and "The worst health you can imagine". The VAS can be used as a quantitative measure of health status.
Measured: The day before surgery and at 1, 3, 6 and 12 months after surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Jan 2025
- Study start1 Jul 2024
- Primary completion5 Sep 2025
- Study completion5 Sep 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Lumbar Disc HerniationStudies 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
- 39 participants (actual)
Sponsor and investigators
- Lead sponsor
- Centre Hospitalier de Colmar
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Jimmy VOIRIN, Principal investigator, Centre Hospitalier de Colmar
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06763224
- Sponsor's protocol ID
- HCC-007
- Other IDs
- 2024-A00923-44
- Acronym
- LomboDN
- Status last verified
- Feb 2026
- First submitted
- 2 Jan 2025
- Last updated
- 6 Feb 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 6 Feb 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prevalence of Neuropathic Pain After Non-instrumented Lumbar Spinal Surgery
- ClinicalTrials.gov ID
- NCT06763224
- Acronym / sponsor ID
- LomboDN / HCC-007
- Conditions
- Lumbar Disc Herniation, Lumbar Spinal Stenosis
- Keywords
- Neuropathic pain, Lumbar spinal surgery
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 39 participants (actual)
- Lead sponsor
- Centre Hospitalier de ColmarUniversity, hospital or other
- Study start
- 1 Jul 2024 (actual)
- Primary completion
- 5 Sep 2025 (actual)
- Study completion
- 5 Sep 2025 (actual)
- First posted
- 8 Jan 2025 (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.
Chronic neuropathic pain following lumbar spine surgery is often under-diagnosed and difficult to relieve. It can persist long after the operation, sometimes for months or even years, and has a major impact on the quality of life of patients who suffer from it. However, the scientific literature on the subject remains relatively poor, as evidenced by the absence of scientific studies on the prevalence of neuropathic pain after lumbar spinal surgery, whether instrumented or not.
The main aim of this study is to determine whether lumbar spine surgery has an impact on the prevalence of neuropathic pain. Participants will be followed up and complete a quality-of-life questionnaire for one year after surgery.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Primary care clinic
Key inclusion criteria (12 listed)
- Patients admitted for scheduled primary lumbar spine surgery without pedicle osteosynthesis or interbody cage.
- Pathology concerned by programmed surgery: herniated disc or lumbar spinal stenosis, uncomplicated by motor or sphincter deficits.
- Delay between 1st painful symptoms and surgery > 48h.
- Surgery scheduled within 48 hours of onset of symptoms.
- Presence of cauda equina syndrome
Key exclusion criteria (0 listed)
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 |
|---|---|---|
| Questionnaire and Physical ExamThe neuropathic pain measured with the Neuropathic pain DN4 Questionnaire (Echelle de la Douleur Neuropathique en 4 questions - Neuropathic Pain Scale in 4 questions) The global pain measured with Visual Analogue Scale (VAS) The patient's permanent functional disability measured with the Oswestry disability index (ODI) The quality of life measured with the questionnaire EuroQol-5 Dimension (EQ-5D-5L) | Other | – |
Primary outcome
Comparison of the proportion of patients with neuropathic pain between the day before surgery and 12 months after surgery.
Time frame: The day before surgery and 12 months after surgery
Comparison of the proportion of patients with a score ≥ 4 measured with the DN4 questionnaire one day before surgery and 12 months after surgery. The DN4 questionnaire (4-question neuropathic pain scale) is a diagnostic tool used to identify and assess neuropathic pain. The questionnaire aims to measure the presence of symptoms and signs commonly associated with neuropathic pain. The questionnaire comprises 10 items: * 7 items relate to the patient's description of his or her pain (burning, painful cold, electric shocks, tingling, numbness, itching). * 3 items are based on the clinician's sensory examination, focusing on touch and pinprick hypoesthesia, as well as brush-induced allodynia. The DN4 is scored out of 10 points. A score of 4 or more suggests the presence of neuropathic pain.
4 secondary outcomes
Evolution of post-operative neuropathic pain
Time frame: At 1, 3 and 6 months after surgery
Evolution of overall pain
Time frame: The day before surgery and at 1, 3, 6 and 12 months after surgery
Evolution of functionality and disability of patients
Time frame: The day before surgery and at 1, 3, 6 and 12 months after surgery
Evolution of quality of life measured with EQ-5D-5L
Time frame: The day before surgery and at 1, 3, 6 and 12 months after surgery
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 6 Feb 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.
Jimmy VOIRIN principal investigator
Centre Hospitalier de Colmar
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 Disc Herniation and Lumbar Spinal Stenosis, run by Centre Hospitalier de Colmar at 1 site in France.
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 12 inclusion and 0 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 6 Feb 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 France. 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?
Comparison of the proportion of patients with neuropathic pain between the day before surgery and 12 months after surgery. (time frame: The day before surgery and 12 months after surgery). 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 6 Feb 2026.