Prevalence of Neuropathic Pain After Non-instrumented Lumbar Spinal Surgery

NCT06763224 | Completed

• 2 other identifiers: HCC-0072024-A00923-44
• Study Type: observational
• Target: 39
• Locations: 1 country
• Sites: 1

Brief 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. 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

Keywords

Neuropathic pain; Lumbar spinal surgery

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (4)

• Evolution of post-operative neuropathic pain

  At 1, 3 and 6 months after surgery

• Evolution of overall pain

  The day before surgery and at 1, 3, 6 and 12 months after surgery

• Evolution of functionality and disability of patients

  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 day before surgery and at 1, 3, 6 and 12 months after surgery

Interventions

Questionnaire and Physical Exam OTHER

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)

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Primary care clinic

You may qualify if:

• 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
• 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.).

Sponsors & Collaborators

• Centre Hospitalier de Colmar: lead

Study Sites (1)

Hôpitaux Civils de Colmar

Colmar, 68024, France

Location

MeSH Terms

Conditions

Intervertebral Disc Displacement; Spinal Stenosis; Neuralgia

Interventions

Surveys and Questionnaires; Restraint, Physical

Condition Hierarchy (Ancestors)

Spinal Diseases; Bone Diseases; Musculoskeletal Diseases; Hernia; Pathological Conditions, Anatomical; Pathological Conditions, Signs and Symptoms; Peripheral Nervous System Diseases; Neuromuscular Diseases; Nervous System Diseases; Pain; Neurologic Manifestations; Signs and Symptoms

Intervention Hierarchy (Ancestors)

Data Collection; Epidemiologic Methods; Investigative Techniques; Health Care Evaluation Mechanisms; Quality of Health Care; Health Care Quality, Access, and Evaluation; Public Health; Environment and Public Health; Behavior Control; Therapeutics; Immobilization

Study Officials

• Jimmy VOIRIN

  Centre Hospitalier de Colmar

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 2, 2025
• First Posted: January 8, 2025
• Study Start: July 1, 2024
• Primary Completion: September 5, 2025
• Study Completion: September 5, 2025
• Last Updated: February 6, 2026

Record last verified: 2026-02

Data Sharing

• IPD Sharing: Will not share

Locations

FR (1)