Hôpitaux Civils de Colmar
Colmar, 68024, France
NCT Number: NCT06763224
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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Notify Me18 year and older
All sexes
Observational
Colmar, 68024, France
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Non-inclusion criteria:
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)
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:
The DN4 is scored out of 10 points. A score of 4 or more suggests the presence of 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:
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.
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.
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.
Centre Hospitalier de Colmar
Other
Acronym: LomboDN
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