Clinical Trial of Pregabalin and COX2 in Spinal Stenosis

Spinal Stenosis Lumbar Clinical Trial

Official title:

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT03584074
• Other study ID #: PreCox2
• Status: Not yet recruiting
• Phase: Phase 4
• Start date: July 1, 2018
• Est. completion date: December 31, 2019

Study information

• Verified date: June 2018
• Source: Seoul National University Bundang Hospital
• Contact: Ho-Joong Kim, M.D., Ph.D
• Phone: +82317872300
• Email: oshjkim[@]gmail.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 60
• Est. completion date: December 31, 2019
• Est. primary completion date: May 30, 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 40 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Constriction, Pathologic
• Spinal Stenosis
• Spinal Stenosis Lumbar

Intervention

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

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Seoul National University Bundang Hospital

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Visual analog scale	Pain score for low back and lower leg	At 8 weeks
Secondary	Pain sensitivity questionnaire (PSQ)	Level of pain sensitivity	At 8 weeks
Secondary	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