Effectiveness of pregabalin for lumbar stenosis: a randomized, controlled trial

Phase 4

• Conditions: umbar spinal stenosis; - Lumbar spinal stenosis; pregabalin; effectiveness; randomized controlled trial

• Registration Number: TCTR20190314001
• Lead Sponsor: Faculty of Medicine, Khon Kaen university

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2019-03-14
• Study Completion: 2019-10-01
• Last Update Posted: 19 August 2024

Recruitment & Eligibility

• Status: Pending (Not yet recruiting)
• Sex: All
• Target Recruitment: 78

Inclusion Criteria

- Diagnosis of lumbar spinal stenosis with symptoms of intermittent neurogenic claudication, VAS for leg pain 4-10, numbness and/or weakness of at least 1 month and confirmation of lumbar spinal stenosis with imaging
- Age 40-80 years

Exclusion Criteria

-Tandem spinal stenosis
-Herniated nucleus pulposus
-Spinal tumor
-Spinal infection
-Compression fracture of thoracolumbar or lumbar spine
-Previous lumbar spine surgery
-Sciatic entrapment neuropathy
-Piriformis syndrome
-Pre-existing hip or knee joint disorder
-Diagnosis of depression
-Poor control diabetes
-Liver or kidney disease (ALT and AST abnormal 2 fold and Serum Cr > 1.4 or GFR < 30 ml/min.
-Allergy of pregabalin
-Pregnancy or lactation period
-Contraindication to NSAID ; recent UGIB, MI, HF, severe uncontrolled HT and NSAID induced asthma

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
eg pain intensity score 8 weeks Self-report questionnaire

Secondary Outcome Measures

Name	Time	Method
ODI, RM, NRS back pain, painDetect questionnaire 4 and 8 weeks self-report questionnaire