Clinical trial NCT06763224: Prevalence of Neuropathic Pain After Non-instrumented Lumbar Spinal Surgery
Official title: Prevalence of Neuropathic Pain After Non-instrumented Lumbar Spinal Surgery
Study type: OBSERVATIONAL
Overall status: ACTIVE_NOT_RECRUITING
Conditions: Lumbar Disc Herniation
Lumbar Spinal Stenosis
Keywords: Neuropathic pain
Lumbar spinal surgery
Lead sponsor: Centre Hospitalier de Colmar
Sponsor class: OTHER
First posted: 2025-01-08
Enrollment: 120
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Primary care clinic

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.


Eligibility criteria: nclusion 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.).

Primary outcomes:
measure: Comparison of the proportion of patients with neuropathic pain between the day before surgery and 12 months after surgery.
timeFrame: The day before surgery and 12 months after surgery
Secondary outcomes:
measure: Evolution of post-operative neuropathic pain
timeFrame: At 1, 3 and 6 months after surgery
measure: Evolution of overall pain
timeFrame: The day before surgery and at 1, 3, 6 and 12 months after surgery
measure: Evolution of functionality and disability of patients
timeFrame: The day before surgery and at 1, 3, 6 and 12 months after surgery
measure: Evolution of quality of life measured with EQ-5D-5L
timeFrame: The day before surgery and at 1, 3, 6 and 12 months after surgery
Other outcomes:
Locations:
city: Colmar
country: France
facility: Hôpitaux Civils de Colmar
Study officials:
affiliation: Centre Hospitalier de Colmar
name: Jimmy VOIRIN
role: PRINCIPAL_INVESTIGATOR
References: