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.
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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
60
Orally taken twice daily for 8 weeks
Orally taken once daily for 8 weeks
Visual analog scale
Pain score for low back and lower leg
Time frame: At 8 weeks
Pain sensitivity questionnaire (PSQ)
Level of pain sensitivity
Time frame: At 8 weeks
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
Time frame: At 8 weeks
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