Low Back Pain Clinical Trial
Official title:
Efficacy and Safety of ARTRA (Glucosamine Plus Chondroitin Sulfate Combination) in Treatment of Non-specific Chronic Low Back Pain of Lumbosacral Localization in Ambulatory Care
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. ;
Observational Model: Cohort, Time Perspective: Prospective
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