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Completed

NCT Number: NCT06763224

Prevalence of Neuropathic Pain After Non-instrumented Lumbar Spinal Surgery

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.

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Key information

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.).

Treatment and study plan

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)

Primary outcomes

  1. 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.

Secondary outcomes

  1. Evolution of post-operative neuropathic pain

    Time frame: 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.
  2. Evolution of overall pain

    Time frame: 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.

  3. Evolution of functionality and disability of patients

    Time frame: 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.

  4. 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

    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.

Sponsors and collaborators

Lead sponsor

Centre Hospitalier de Colmar

Other

Registry information

Acronym: LomboDN

Important dates

Study start
2024
Primary completion
2025
Study completion
2025
First posted
Jan 8, 2025
Registry last updated
Feb 6, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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