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Randomized Controlled Trial
. 2008 Oct 20:9:143.
doi: 10.1186/1471-2474-9-143.

Effect of tadalafil on blood flow, pain, and function in chronic cold complex regional pain syndrome: a randomized controlled trial

George Groeneweg  1 , Frank J P M Huygen, Sjoerd P Niehof, Feikje Wesseldijk, Johannes B J Bussmann, Fabienne C Schasfoort, Dirk L Stronks, Freek J Zijlstra
Affiliations
Randomized Controlled Trial

Effect of tadalafil on blood flow, pain, and function in chronic cold complex regional pain syndrome: a randomized controlled trial

George Groeneweg et al. BMC Musculoskelet Disord. .

Abstract

Background: This double-blind, randomized, controlled trial investigated the effect of the phosphodiesterase-5 inhibitor tadalafil on the microcirculation in patients with cold Complex Regional Pain Syndrome (CRPS) in one lower extremity.

Methods: Twenty-four patients received 20 mg tadalafil or placebo daily for 12 weeks. The patients also participated in a physical therapy program. The primary outcome measure was temperature difference between the CRPS side and the contralateral side, determined by measuring the skin temperature with videothermography. Secondary outcomes were: pain measured on a Visual Analogue Scale, muscle force measured with a MicroFet 2 dynamometer, and level of activity measured with an Activity Monitor (AM) and walking tests.

Results: At the end of the study period, the temperature asymmetry was not significantly reduced in the tadalafil group compared with the placebo group, but there was a significant and clinically relevant reduction of pain in the tadalafil group. Muscle force improved in both treatment groups and the AM revealed small, non-significant improvements in time spent standing, walking, and the number of short walking periods.

Conclusion: Tadalafil may be a promising new treatment for patients that have chronic cold CRPS due to endothelial dysfunction, and deserves further investigation.

Trial registration: The registration number in the Dutch Trial Register is ISRCTN60226869.

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Figures

Figure 1
Figure 1
Flowchart Talafil study.
See this image and copyright information in PMC

References

    1. Stanton-Hicks M, Janig W, Hassenbusch S, Haddox JD, Boas R, Wilson P. Reflex sympathetic dystrophy: changing concepts and taxonomy. Pain. 1995;63:127–133. doi: 10.1016/0304-3959(95)00110-E. - DOI - PubMed
    1. Baron R, Schattschneider J, Binder A, Siebrecht D, Wasner G. Relation between sympathetic vasoconstrictor activity and pain and hyperalgesia in complex regional pain syndromes: a case-control study. Lancet. 2002;359:1655–1660. doi: 10.1016/S0140-6736(02)08589-6. - DOI - PubMed
    1. Bruehl S, Harden RN, Galer BS, Saltz S, Bertram M, Backonja M, Gayles R, Rudin N, Bhugra MK, Stanton-Hicks M. External validation of IASP diagnostic criteria for Complex Regional Pain Syndrome and proposed research diagnostic criteria. International Association for the Study of Pain. Pain. 1999;81:147–154. doi: 10.1016/S0304-3959(99)00011-1. - DOI - PubMed
    1. Harden RN, Bruehl SP. Diagnosis of complex regional pain syndrome: signs, symptoms, and new empirically derived diagnostic criteria. Clin J Pain. 2006;22:415–419. doi: 10.1097/01.ajp.0000194279.36261.3e. - DOI - PubMed
    1. Janig W, Baron R. Complex regional pain syndrome: mystery explained? Lancet Neurol. 2003;2:687–697. doi: 10.1016/S1474-4422(03)00557-X. - DOI - PubMed

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