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Randomized Controlled Trial Clinical Trial
A randomized, double-blind, placebo controlled triphosphate in study of oral adenosine subacute low back pain.
- Bernard Bannwarth, François-Andre Allaert, Bernard Avouac, Michel Rossignol, Sylvie Rozenberg, and Jean-Pierre Valat.
- Department of Rheumatology, Groupe Hospitalier Pellegrin and Division of Therapeutics, EA 525, Victor Segalen University, Bordeaux, France. bernard.bannwarth@u-bordeaux2.fr
- J Rheumatol. 2005 Jun 1;32(6):1114-7.
ObjectiveTo assess the efficacy and safety of oral adenosine triphosphate (ATP) in subacute low back pain.MethodsThis was a randomized, double-blind, parallel group, placebo controlled clinical trial. The patients were given either ATP 90 mg once daily (n=81) or placebo (n=80) for one month. The patients were assessed 3 times during the study period, at days 0, 7, and 30. The primary outcome measure was the Roland-Morris Disability Questionnaire (RDQ) at day 30. Secondary measures of efficacy included visual analog scale (VAS) pain, overall assessments of efficacy by both patient and investigator, and number of dextropropoxyphene and acetaminophen combination tablets used as rescue analgesic.ResultsRegarding the RDQ, the mean values dropped from 10.3 +/-2.8 at baseline to 7.5 +/-3.8 (day 7) and 5.2 +/-5.2 (day 30) in the ATP group, and from 11.0 +/- 3.5 to 9.1 +/- 4.2 (day 7) and 6.1 +/- 4.3 (day 30) in the placebo group. The difference between the 2 groups was statistically significant at day 7 (p= 0.02) but not at day 30 (p=0.2). In other words, the mean changes from baseline were 2.8 +/- 3.1 and 2.0 +/- 2.6 at day 7 (p=0.06), and 5.1 +/- 3.9 and 5.0 +/- 4.2 at day 30 (p=0.78) in the ATP group and the placebo group, respectively. There were no statistically significant differences in the VAS pain and overall assessments of efficacy between groups at any time point during the study. Conversely, there was a significant difference in the use of the rescue analgesic between groups, in favor of ATP (p=0.04). Oral ATP was well tolerated.ConclusionOral ATP might have an early acting effect in subacute low back pain.
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