To study the safety and efficacy of ARTRA (glucosamine chondroitin sulfate) in the treatment of non-specific low-back pain of lumbosacral localization in ambulatory care.
We enrolled patients between 40 and 65 years of age who had low back pain for at least 12 weeks with a pain intensity \>3 on a 0-10 point visual analogue scale (VAS). Major exclusion criteria were presence of fibromyalgia, degenerative spondylolisthesis, and alcohol and/or drug abuse. All patients were treated with ARTRA (combination of glucosamine hydrochloride 500 mg and chondroitin sulfate 500 mg in tab; Unipharm Inc.) at a dose of 1 tab bid for the first month and then 1 tab daily for the next two months. The primary endpoint was pain intensity (at rest and movement) as measured on a 0-10 point VAS. Secondary endpoints included Oswestry Disability Index, patient global assessment of efficacy (0-5 scale) and NSAID consumption.
Study Type
OBSERVATIONAL
Enrollment
10,000
ARTRA (glucosamine and chondroitin sulfate)
FGBU "State NII of Rheumatology" of RAMS
Moscow, Russia
Pain Intensity
Pain intensity on Visual Analogue Scale
Time frame: 3 months
Oswestry Disability Index
Time frame: 3 months
Patient global assessment of efficacy
Time frame: 3 months
NSAID consumption
Number of patients taking NSAIDs
Time frame: 3 months
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