Clinical Trial of Pregabalin and COX2 in Spinal Stenosis

Seoul National University

Status and phase: Unknown; Phase 4

Conditions: Spinal Stenosis Lumbar

Treatments: Drug: Pregabalin 75mg; Drug: Celebrex 200Mg Capsule

Study type: Interventional

Funder types: Other

Identifiers

NCT03584074

PreCox2

Details and patient eligibility

About

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 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.

Enrollment: 60 estimated patients

Sex: All

Ages: 40+ years old

Volunteers: No 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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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60 participants in 2 patient groups

Pregabalin and COX-2 inhibitor

Experimental group

Description:

Pregabalin 75mg BID + Celecoxib 200mg qd

Treatment:

Drug: Pregabalin 75mg

Drug: Celebrex 200Mg Capsule

COX-2 inhibitor

Active Comparator group

Description:

Celecoxib 200mg qd

Treatment:

Drug: Celebrex 200Mg Capsule