A randomized placebo-controlled pilot study of the efficacy and safety of D-cycloserine in people with chronic back pain

Thomas J Schnitzer, Souraya Torbey, Kristi Herrmann, Gagan Kaushal, Renita Yeasted, A Vania Apkarian, Thomas J Schnitzer, Souraya Torbey, Kristi Herrmann, Gagan Kaushal, Renita Yeasted, A Vania Apkarian

Abstract

Background: Few effective pharmacological treatment options exist for chronic back pain, the leading cause of disability in the US, and all are associated with significant adverse effects.

Objective: To determine the efficacy and safety of D-cycloserine, a partial agonist to the N-methyl-D-aspartate receptor, in the treatment of chronic low back pain.

Methods: A total of 41 participants with chronic back pain who met all inclusion and exclusion criteria were enrolled in a double-blind, placebo-controlled randomized pilot trial of D-cycloserine. Treatment was administered orally for six weeks at escalating daily doses of 100 mg, 200 mg, and 400 mg, each for two weeks. The primary outcome measure was back pain intensity using the Numeric Rating Scale (0-10). Secondary measures were back pain-related questionnaires: McGill Pain Questionnaire short form, painDETECT, PANAS, and BDI. The pre-specified analysis was a two-way repeated measures analysis of variance.

Results: A treatment difference was observed between groups treated with D-cycloserine and placebo at six weeks of 1.05 ± 3.1 units on the Numeric Rating Scale, with an effect size of 0.4 and p = 0.14. This trend of better chronic back pain relief with D-cycloserine was also observed in the secondary measures. No safety issues were seen.

Conclusion: The difference in mean pain between the D-cycloserine and placebo groups did not reach statistical significance. However, a clinically meaningful effect size in the magnitude of pain relief was observed with a consistent pattern across multiple outcome measures with good safety, supporting further research into the effectiveness of D-cycloserine for chronic back pain.

Keywords: D-cycloserine; N-methyl-D-aspartate agonist; chronic back pain; clinical trial; randomized.

© The Author(s) 2016.

Figures

Figure 1.
Figure 1.
Consort diagram.
Figure 2.
Figure 2.
Back pain intensity ratings over a six-week, dose escalating, placebo or DCS treatment in CBP. (a) Across subject average back pain, assessed on the primary outcome measure of 0–10 numeric rating scale. (b) Within subject change in pain, relative to baseline, using the 0–10 numeric rating scale. Error bars are SEMs.
Figure 3.
Figure 3.
Back pain related secondary outcome measures showing improved back pain with six-week DCS treatment. (a) Affective score of McGill Pain Questionnaire short form (sf-MPQ). (b) sf-MPQ sensory score. (c) Pain DETECT. (d) PANAS positive affect score. All measures indicate a trend or significant improvement with DCS in comparison to placebo. Error bars are SEMs.

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Source: PubMed

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