Comparative Study for Decrease of Pain Intensity and Pain Sensitivity Between Pregabalin + COX-2 Inhibitor and COX-2 Inhibitor in Patients With Lumbar Spinal Stenosis: Randomized Controlled Trial
Overview
- Phase
- Phase 4
- Intervention
- Pregabalin 75mg
- Conditions
- Spinal Stenosis Lumbar
- Sponsor
- Seoul National University Bundang Hospital
- Enrollment
- 60
- Primary Endpoint
- Visual analog scale
- Last Updated
- 7 years ago
Overview
Brief Summary
Aim of this prospective, single-blind, randomized study was to compare the efficacy of the combination of celecoxib and pregabalin and celecoxib only monotherapy for treatment of chronic low-back pain.
Detailed Description
The efficacy and safety of the association of celecoxib \[a selective cyclooxygenase-2 (COX-2) inhibitor\] and pregabalin (commonly used to control neuropathic pain), compared with monotherapy of each, were evaluated for the treatment of chronic low-back pain, a condition known to be due to neuropathic as well as nociceptive pain mechanisms. We will compare the efficacy of the combination of a selective COX-2 inhibitor (celecoxib) and an antineuropathic drug, pregabalin, versus celecoxib only monotherapy, in the treatment of spinal stenosis. Each treatment lasted 8 weeks Primary outcome is mean pain reduction following different treatments regimes. Secondary outcomes are the changes of pain sensitivity, Oswestry disability index, adverse effects due to the treatments under study.
Investigators
Ho-Joong Kim
Associate Professor
Seoul National University Bundang Hospital
Eligibility Criteria
Inclusion Criteria
- •Spinal stenosis
Exclusion Criteria
- •Koval grade \>=3
- •Other musculoskeletal disorders which cause pain on other joint
- •Bleeding risk or ulcer history
- •Severe cardiovascular, pulmonary, renal, brain, liver dysfunction
Arms & Interventions
Pregabalin and COX-2 inhibitor
Pregabalin 75mg BID + Celecoxib 200mg qd
Intervention: Pregabalin 75mg
Pregabalin and COX-2 inhibitor
Pregabalin 75mg BID + Celecoxib 200mg qd
Intervention: Celebrex 200Mg Capsule
COX-2 inhibitor
Celecoxib 200mg qd
Intervention: Celebrex 200Mg Capsule
Outcomes
Primary Outcomes
Visual analog scale
Time Frame: At 8 weeks
Pain score for low back and lower leg
Secondary Outcomes
- Pain sensitivity questionnaire (PSQ)(At 8 weeks)
- Oswestry disability index (ODI)(At 8 weeks)