Clinical Trial of Pregabalin and COX2 in Spinal Stenosis

Phase 4

• Conditions: Spinal Stenosis Lumbar
• Interventions: Drug: Pregabalin 75mg; Drug: Celebrex 200Mg Capsule

• Registration Number: NCT03584074
• Lead Sponsor: Seoul National University Bundang Hospital

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.

Study Timeline

• Status Verified: 2018-06
• Study First Submitted: 2018-06-29
• Study First Submitted QC: 2018-06-29
• Last Update Submitted: 2018-06-29
• Study Start: 2018-07-01
• Study First Posted: 2018-07-12
• Last Update Posted: 2018-07-12
• Primary Completion: 2019-05-30
• Study Completion: 2019-12-31

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 60

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Pregabalin and COX-2 inhibitor	Celebrex 200Mg Capsule	Pregabalin 75mg BID + Celecoxib 200mg qd
Pregabalin and COX-2 inhibitor	Pregabalin 75mg	Pregabalin 75mg BID + Celecoxib 200mg qd
COX-2 inhibitor	Celebrex 200Mg Capsule	Celecoxib 200mg qd

Primary Outcome Measures

Name	Time	Method
Visual analog scale	At 8 weeks	Pain score for low back and lower leg

Secondary Outcome Measures

Name	Time	Method
Pain sensitivity questionnaire (PSQ)	At 8 weeks	Level of pain sensitivity
Oswestry disability index (ODI)	At 8 weeks	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