Clinical Trial of Pregabalin and COX2 in Spinal Stenosis

Overview

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.

Full Title of Study: “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”

Study Type

  • Study Type: Interventional
  • Study Design
    • Allocation: Randomized
    • Intervention Model: Parallel Assignment
    • Primary Purpose: Treatment
    • Masking: None (Open Label)
  • Study Primary Completion Date: May 30, 2019

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.

Interventions

  • Drug: Pregabalin 75mg
    • Orally taken twice daily for 8 weeks
  • Drug: Celebrex 200Mg Capsule
    • Orally taken once daily for 8 weeks

Arms, Groups and Cohorts

  • Experimental: Pregabalin and COX-2 inhibitor
    • Pregabalin 75mg BID + Celecoxib 200mg qd
  • Active Comparator: COX-2 inhibitor
    • Celecoxib 200mg qd

Clinical Trial Outcome Measures

Primary Measures

  • Visual analog scale
    • Time Frame: At 8 weeks
    • Pain score for low back and lower leg

Secondary Measures

  • Pain sensitivity questionnaire (PSQ)
    • Time Frame: At 8 weeks
    • Level of pain sensitivity
  • Oswestry disability index (ODI)
    • Time Frame: 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

Participating in This Clinical Trial

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

Gender Eligibility: All

Minimum Age: 40 Years

Maximum Age: N/A

Are Healthy Volunteers Accepted: No

Investigator Details

  • Lead Sponsor
    • Seoul National University Bundang Hospital
  • Provider of Information About this Clinical Study
    • Principal Investigator: Ho-Joong Kim, Associate Professor – Seoul National University Bundang Hospital
  • Overall Contact(s)
    • Ho-Joong Kim, M.D., Ph.D, +82317872300, oshjkim@gmail.com

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