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Clinical Trials/NCT06763224
NCT06763224
Completed
Not Applicable

Prevalence of Neuropathic Pain After Non-instrumented Lumbar Spinal Surgery

Centre Hospitalier de Colmar1 site in 1 country39 target enrollmentJuly 1, 2024

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Lumbar Disc Herniation
Sponsor
Centre Hospitalier de Colmar
Enrollment
39
Locations
1
Primary Endpoint
Comparison of the proportion of patients with neuropathic pain between the day before surgery and 12 months after surgery.
Status
Completed
Last Updated
2 months ago

Overview

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.

Registry
clinicaltrials.gov
Start Date
July 1, 2024
End Date
September 5, 2025
Last Updated
2 months ago
Study Type
Observational
Sex
All

Investigators

Sponsor
Centre Hospitalier de Colmar
Responsible Party
Sponsor

Eligibility Criteria

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

Exclusion Criteria

  • Not provided

Outcomes

Primary Outcomes

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

  • 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)

Study Sites (1)

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