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

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

Status
Active, not recruiting
Phases
Phase 4
Study type
Interventional
Source
TCTR
Registry ID
TCTR20190314001
Enrollment
78
Registered
2019-03-14
Start date
2019-04-01
Completion date
Unknown
Last updated
2026-08-03

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Lumbar spinal stenosis &#45

Interventions

Pregabalin 75 mg po&#44
bid Naproxen 250 mg po&#44
bid Omeprazole 20 mg po&#44
od Paracetamol 500 mg po&#44
tid ,Naproxen 250 mg po&#44
tid
Active Comparator Drug,Placebo Comparator Drug
Pregabalin group,Placebo group

Sponsors

Faculty of Medicine, Khon Kaen university
Lead Sponsor
Faculty of Medicine&#44
Collaborator
Khon Kaen university
Collaborator

Eligibility

Sex/Gender
All
Age
40 Years to 80 Years

Inclusion criteria

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

Exclusion criteria: &#45; Tandem spinal stenosis &#45; Herniated nucleus pulposus &#45; Spinal tumor &#45; Spinal infection &#45; Compression fracture of thoracolumbar or lumbar spine &#45; Previous lumbar spine surgery &#45; Sciatic entrapment neuropathy &#45; Piriformis syndrome &#45; Pre&#45;existing hip or knee joint disorder &#45; Diagnosis of depression &#45; Poor control diabetes &#45; Liver or kidney disease (ALT and AST abnormal 2 fold and Serum Cr > 1.4 or GFR < 30 ml/min. &#45; Allergy of pregabalin &#45; Pregnancy or lactation period &#45; Contraindication to NSAID ; recent UGIB&#44; MI&#44; HF&#44; severe uncontrolled HT and NSAID induced asthma

Design outcomes

Primary

MeasureTime frame
Leg pain intensity score 8 weeks Self&#45;report questionnaire

Secondary

MeasureTime frame
ODI&#44; RM&#44; NRS back pain&#44; painDetect questionnaire 4 and 8 weeks self&#45;report questionnaire

Countries

Thailand

Contacts

Public ContactKriangkrai Wittayapairoj

Khon Kaen university

wkriang@kku.ac.th0894223990

Outcome results

None listed

Source: TCTR (via WHO ICTRP) · Data processed: Aug 9, 2026