Clinical Trial of Pregabalin and COX2 in Spinal Stenosis

• Register: ClinicalTrials.gov
• Last refreshed on: 12 December 2020
• Main ID: NCT03584074
• Date of registration: 29/06/2018
• Prospective Registration: Yes
• Primary sponsor: Seoul National University Bundang Hospital
• Public title: Clinical Trial of Pregabalin and COX2 in Spinal Stenosis
• Scientific 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
• Date of first enrolment: July 1, 2018
• Target sample size: 60
• Recruitment status: Unknown status
• URL: https://clinicaltrials.gov/show/NCT03584074
• Study type: Interventional
• Study design: Allocation: Randomized. Intervention model: Parallel Assignment. Primary purpose: Treatment. Masking: None (Open Label).
• Phase: Phase 4

Contacts

• Name: Ho-Joong Kim, M.D., Ph.D

Key inclusion & exclusion criteria

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



Age minimum: 40 Years
Age maximum: N/A
Gender: All

Health Condition(s) or Problem(s) studied

Spinal Stenosis Lumbar

Intervention(s)

Drug: Celebrex 200Mg Capsule

Drug: Pregabalin 75mg

Primary Outcome(s)

Visual analog scale [Time Frame: At 8 weeks]

Secondary Outcome(s)

Pain sensitivity questionnaire (PSQ) [Time Frame: At 8 weeks]

Oswestry disability index (ODI) [Time Frame: At 8 weeks]

Secondary ID(s)

PreCox2

Source(s) of Monetary Support

Please refer to primary and secondary sponsors