Lumbar spinal stenosis patients with intermittent neurogenic claudication Neurogenic Claudication Lumbar Spinal Stenosis Gabapentin Pregabalin Randomized Controlled Trials Pain Management Quality of Life Walking Distance
Conditions
Interventions
All Participants received the same standard conservative management, which included back exercise education (avoiding excessive lumbar flexion and extension, lifting heavy objects, and strengthening a
s standard effective dose titration. The GBP group received oral gabapentin (GBP) three times daily, starting at 300 mg/day for the first week. The dose was titrated on day 7 to 900 mg/day and up to 1
Placebo,Gabapentin,Pregabalin
Sponsors
Faculty of medicinSiriraj hospital, Mahidol university
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Inclusion criteria
Inclusion criteria: Participants were included if they met all four of the following criteria: 1) a clinical history with predominant symptoms of NIC, defined as pain, tiredness, heaviness and/or numbness in the lower extremities associated with prolonged standing or walking relieved by sitting or flexing forward of the spine, with or without low back pain 2) NIC symptoms had to persist for more than 3 months prior to inclusion 3) MRI-confirmed LSS, including central stenosis or lateral recess stenosis, with or without concomitant lumbar spondylosis or low-grade degenerative spondylolisthesis (grade I or II) 4) No prior pharmacologic treatment for LSS symptoms, including nonsteroidal anti-inflammatory drugs, gabapentinoids, or oral prostaglandin E1 analogs within 3 months
Exclusion criteria
Exclusion criteria: 1) Peripheral arterial occlusive diseases (PAOD); defined as an ABI less than 0.9, 2) Pregnancy or breastfeeding, 3) epilepsy, 4) Chronic kidney disease with creatinine clearance less than 60 mL/min, 5) Liver cirrhosis 6) Previous spinal surgery or epidural steroid injection, 7) Cauda equina syndrome or Present of muscle weakness with motor power grade 3 or less by Medical Research Council (MRC) scale, 8) Other spinal pathology, including spondylodiscitis or primary or metastatic spinal tumors, 9) Participants unable to complete questionnaires or follow-ups due to cognitive disorders or lack of cooperation, 10) Allergy to paracetamol, gabapentin, and/or pregabalin.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| visual analog pain scale (VAS) for patient's Nuerogenic intermittent claudication symptom 1, 2, 3, and 4 monts follow-up VAS pain scale | — |
Secondary
| Measure | Time frame |
|---|---|
| Swiss Spinal Stenosis Score (SSS) 1, 2, 3, and 4 monts follow-up SSS score ,self-paced shuttle walk test (SPSWT) 1, 2, 3, and 4 monts follow-up SPWT score,Time to onset of claudication symptoms 1, 2, 3, and 4 monts follow-up minutes,Euro- QoL Group 5-dimension, 5 level (EQ5D5L) 1, 2, 3, and 4 monts follow-up EQ5D5L,side effects and adverse events (AE) of the treatment. 1, 2, 3, and 4 monts follow-up incidence | — |
Countries
Thailand
Contacts
Public Contactkorawish mekariya
Faculty of Medicine Siriraj hospital, Mahidol University.
Outcome results
None listed