Prevalence of Neuropathic Pain After Non-instrumented Lumbar Spinal Surgery (LomboDN)

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 Overview

• Status: Completed
• Conditions: Lumbar Disc Herniation; Lumbar Spinal Stenosis
• Intervention / Treatment: Other: Questionnaire and Physical Exam

• Study Type: Observational
• Enrollment (Actual): 39

Contacts and Locations

Study Locations

• France
  • Colmar, France, 68024
    • Hôpitaux civils de Colmar

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

• Sampling Method: Non-Probability Sample

Study Population

Primary care clinic

Description

Inclusion criteria:

• 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
• 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.).

Study Plan

How is the study designed?

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	The day before surgery and 12 months after surgery

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	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.	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.	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.	The day before surgery and at 1, 3, 6 and 12 months after surgery

Collaborators and Investigators

• Sponsor: Centre Hospitalier de Colmar
• Investigators: Principal Investigator: Jimmy VOIRIN, Centre Hospitalier de Colmar

Study record dates

Study Major Dates

• Study Start (Actual): July 1, 2024
• Primary Completion (Actual): September 5, 2025
• Study Completion (Actual): September 5, 2025

Study Registration Dates

• First Submitted: January 2, 2025
• First Submitted That Met QC Criteria: January 2, 2025
• First Posted (Actual): January 8, 2025

Study Record Updates

• Last Update Posted (Actual): February 6, 2026
• Last Update Submitted That Met QC Criteria: February 5, 2026
• Last Verified: February 1, 2026

More Information

Terms related to this study

• Keywords: Neuropathic pain; Lumbar spinal surgery
• Additional Relevant MeSH Terms: Pain; Neurologic Manifestations; Bone Diseases; Musculoskeletal Diseases; Nervous System Diseases; Pathological Conditions, Anatomical; Neuromuscular Diseases; Peripheral Nervous System Diseases; Spinal Diseases; Hernia; Pathological Conditions, Signs and Symptoms; Signs and Symptoms; Intervertebral Disc Displacement; Spinal Stenosis; Neuralgia; Health Care Quality, Access, and Evaluation; Investigative Techniques; Epidemiologic Methods; Therapeutics; Data Collection; Health Care Evaluation Mechanisms; Quality of Health Care; Public Health; Environment and Public Health; Behavior Control; Immobilization; Surveys and Questionnaires; Restraint, Physical
• Other Study ID Numbers: HCC-007; 2024-A00923-44 (Other Identifier: ID-RCB ANSM)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No