Clinical Trial of Pregabalin and COX2 in Spinal Stenosis

Study Overview
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Brief Summary
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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
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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.

Official Title
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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

Conditions
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Spinal Stenosis Lumbar

Intervention / Treatment
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* Drug: Pregabalin 75mg
* Drug: Celebrex 200Mg Capsule


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 40 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Pregabalin and COX-2 inhibitor<br>Pregabalin 75mg BID + Celecoxib 200mg qd | Drug: Pregabalin 75mg<br>* Orally taken twice daily for 8 weeks<br>Drug: Celebrex 200Mg Capsule<br>* Orally taken once daily for 8 weeks<br>|
| Active Comparator: COX-2 inhibitor<br>Celecoxib 200mg qd | Drug: Celebrex 200Mg Capsule<br>* Orally taken once daily for 8 weeks<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Visual analog scale | Pain score for low back and lower leg | At 8 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Pain sensitivity questionnaire (PSQ) | Level of pain sensitivity | At 8 weeks | 
| Oswestry disability index (ODI) | The self-completed questionnaire contains ten topics concerning intensity of pain, lifting, ability to care for oneself, ability to walk, ability to sit, sexual function, ability to stand, social life, sleep quality, and ability to travel | At 8 weeks | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Pregabalin, Selective COX-2 inhibitor