Prevalence of Neuropathic Pain After Non-instrumented Lumbar Spinal Surgery

Active, not recruiting

• Conditions: Lumbar Disc Herniation; Lumbar Spinal Stenosis

• Registration Number: NCT06763224
• Lead Sponsor: Centre Hospitalier de Colmar

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2024-07-01
• Status Verified: 2025-01
• Study First Submitted: 2025-01-02
• Study First Submitted QC: 2025-01-02
• Study First Posted: 2025-01-08
• Last Update Submitted: 2025-01-09
• Last Update Posted: 2025-01-10
• Primary Completion: 2025-09-30
• Study Completion: 2025-09-30

Recruitment & Eligibility

• Status: ACTIVE_NOT_RECRUITING
• Sex: All
• Target Recruitment: 120

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Comparison of the proportion of patients with neuropathic pain between the day before surgery and 12 months after surgery.	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.

Secondary Outcome Measures

Name	Time	Method
Evolution of post-operative neuropathic pain	At 1, 3 and 6 months after surgery	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.
Evolution of overall pain	The day before surgery and at 1, 3, 6 and 12 months after surgery	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.
Evolution of functionality and disability of patients	The day before surgery and at 1, 3, 6 and 12 months after surgery	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.
Evolution of quality of life measured with EQ-5D-5L	The day before surgery and at 1, 3, 6 and 12 months after surgery	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.

Trial Locations

Locations (1)

Hôpitaux Civils de Colmar; 🇫🇷 Colmar, France