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National Technical Information Service; 2020.
Non-conventional in English | National Technical Information Service | ID: grc-753555

ABSTRACT

Chronic low back pain constitutes the major form of chronic pain, with a prevalence as high as 70-85 percent in adults at some time in their lives. This 26-week, double blind, randomized, placebo controlled two-arm parallel-group study will evaluate 244 participants to determine if treatment with d-cycloserine in individuals with chronic, refractory low back pain will demonstrate greater reduction in pain compared to individuals treated with placebo. After a two-week screening period, individuals are randomized to receive either 12 weeks of d-cycloserine or placebo and then followed for an additional 12 weeks to evaluate persistence of benefit at study endpoint, 24 weeks after randomization. Follow-up visits and data collection will occur at baseline and 2, 6, 12, and 24 weeks after randomization to assess general health, pain, proper treatment use, and side effects. Pain and safety will also be assessed at 16 and 20 weeks after randomization by phone calls.

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