Radicular pain
Conditions
Interventions
Sponsors
Eligibility
Inclusion criteria
Inclusion criteria: 1. Participants with unilateral sciatica persisting for >1 month, accompanied by pain-induced activity impairment (e.g., slow walking, limping, or maximum walking distance <=500 meters) or daily life-limiting symptoms (e.g., inability to maintain supine position, sleep disturbance, or inability to maintain sitting position); 2. Lumbar MRI shows suspected L5 or S1 nerve root compression on the symptomatic side at the L4-5 or L5-S1 segment, with unconfirmed correlation to clinical pain. This includes:(1) One or more of the following: lumbar disc herniation (MSU classification: 1-B, 1-A, or 2-A), lateral recess stenosis (grade 2 or 3), or foraminal stenosis (Lee grade 2 or 3), with or without concurrent nerve root compression at other segments;(2) Atypical sciatica, or inconsistencies between pain location, imaging findings and physical examination results;(3) Uncertainty in distinguishing suspected compressive lesions from normal neural structures on imaging; 3. Participants who elected surgical treatment after full informed consent regarding the risks and benefits of all available treatment modalities, and are candidates for lumbar single-segment, single-nerve-root decompression.
Exclusion criteria
Exclusion criteria: 1.Absence of significant pain prior to SINRB or surgery, or lower limb weakness/numbness as the primary symptom; 2.The surgical outcome can't confirm the responsible nerve root: for example, the intended decompression or fusion scope involves more than one spinal segment, or non-single nerve root decompression is planned; 3.Suspected compression of nerve fibers originating from the same nerve root exists at two or more segments. Examples include lateral recess stenosis at one level combined with moderate-to-severe central canal stenosis (Lee grade 2 or 3) at the cephalad adjacent level, or lateral spinal stenosis at L4-5 combined with extreme lateral disc herniation or severe foraminal stenosis (Lee grade 3) at the same side of L5-S1; 4.Pregnancy, active malignant tumor, or other surgical contraindications precluding elective surgery; 5.Inability to cooperate with activity impairment assessment, including but not limited to: concurrent severe hearing impairment, mental illness, language communication barriers, hip/lower limb organic lesions, cerebral infarction sequelae, Parkinson’s syndrome, poliomyelitis, or other diseases causing walking dysfunction.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The change from baseline in standing impairment;Change from baseline in walking impairment;Change from baseline in straight leg raising impairment;Subjective pain relief; | — |
Secondary
| Measure | Time frame |
|---|---|
| Result of SINRB;Overall clinical assessment after lumbar spine surgery;The occurrence of complications;Changes in neurological function before and after SINRB;Success rate of SINRB procedure; | — |
Countries
China
Contacts
Xi'an Honghui Hospital