Clinical Trial of Pregabalin and COX2 in Spinal Stenosis

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

Status

UNKNOWN

Phases

Phase 4

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT03584074

Enrollment

Registered

2018-07-12

Start date

2018-07-01

Completion date

2019-12-31

Last updated

2018-07-12

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

Conditions

Spinal Stenosis Lumbar

Keywords

Pregabalin, Selective COX-2 inhibitor

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.

Interventions

DRUGPregabalin 75mg

Orally taken twice daily for 8 weeks

DRUGCelebrex 200Mg Capsule

Orally taken once daily for 8 weeks

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

40 Years to No maximum

Healthy volunteers

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

Design outcomes

Primary

Measure	Time frame	Description
Visual analog scale	At 8 weeks	Pain score for low back and lower leg

Secondary

Measure	Time frame	Description
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

Contacts

Primary ContactHo-Joong Kim, M.D., Ph.D

oshjkim@gmail.com+82317872300

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026