"Efficacy of Botulinum Toxin Injection in Reducing Limb Pain in Patients With Complex Regional Pain Syndrome"

Summary

Objective: The primary aim is to evaluate the efficacy of botulinum toxin A in reducing overall limb pain in patients with complex regional pain syndrome (CRPS). Additionally the investigators would like to see if quality of life is improved and disability scores decreased. Research Design: This is a double blinded, randomized cross-over study that will be conducted over a 7 month period. It is a pilot study that will include twenty subjects recruited from the Neurology CRPS clinic at VA Connecticut and from outside VA hospitals within a 150 mile radius. Subjects will receive an intramuscular injection Treatment A which is only 1% lidocaine or Treatment B which is mixture of botulinum toxin A + 1% lidocaine in the affected limb only. This is a cross over study where patients will receive Treatment A or B initially during the first of four study visits and during the third study visit while receive whichever treatment not given during the first visit. Dr. Sameer Ali, VA neurology fellow, will be blinded when administering the treatments. Dr. Hajime Tokuno, VA neurologist who is the principal investigator of the trial will prepare the treatments. Clinical pharmacy will be randomizing the treatments. Dr. Tokuno will not be blinded as he needs to know which treatment has been given in case of complications. Impact/Significance: The significance of this study is the possible discovery of a new, safer, less invasive, and more efficacious therapeutic option for patients suffering from CRPS. Currently medical management with neuropathic pain meds, interventions such as sympathetic nerve blocks and ketamine infusion has helped some patients and not others. The investigators are trying to see whether either of the two treatments and especially the treatment with botulinum toxin may be a more viable alternative than existing modalities.

Timeline

Start

2016-07

Primary completion

2019-12

Completion

2019-12

Publications

• Background Argoff CE. A focused review on the use of botulinum toxins for neuropathic pain. Clin J Pain. 2002 Nov-Dec;18(6 Suppl):S177-81. doi: 10.1097/00002508-200211001-00010.
• Background Birthi P, Sloan P, Salles S. Subcutaneous botulinum toxin A for the treatment of refractory complex regional pain syndrome. PM R. 2012 Jun;4(6):446-9. doi: 10.1016/j.pmrj.2011.12.010. No abstract available.
• Background Borchers AT, Gershwin ME. Complex regional pain syndrome: a comprehensive and critical review. Autoimmun Rev. 2014 Mar;13(3):242-65. doi: 10.1016/j.autrev.2013.10.006. Epub 2013 Oct 23.
• Background Choi E, Lee PB, Nahm FS. Interexaminer reliability of infrared thermography for the diagnosis of complex regional pain syndrome. Skin Res Technol. 2013 May;19(2):189-93. doi: 10.1111/srt.12032. Epub 2013 Jan 20.
• Background Chen S. Clinical uses of botulinum neurotoxins: current indications, limitations and future developments. Toxins (Basel). 2012 Oct;4(10):913-39. doi: 10.3390/toxins4100913. Epub 2012 Oct 19.
• Background Jeong MY, Yu JS, Chung WB. Usefulness of thermography in diagnosis of complex regional pain syndrome type I after transradial coronary intervention. J Invasive Cardiol. 2013 Sep;25(9):E183-5.
• Background Kalandakanond S, Coffield JA. Cleavage of SNAP-25 by botulinum toxin type A requires receptor-mediated endocytosis, pH-dependent translocation, and zinc. J Pharmacol Exp Ther. 2001 Mar;296(3):980-6.
• Background Niehof SP, Huygen FJ, Stronks DL, Klein J, Zijlstra FJ. Reliability of observer assessment of thermographic images in complex regional pain syndrome type 1. Acta Orthop Belg. 2007 Feb;73(1):31-7.
• Background Niehof SP, Beerthuizen A, Huygen FJ, Zijlstra FJ. Using skin surface temperature to differentiate between complex regional pain syndrome type 1 patients after a fracture and control patients with various complaints after a fracture. Anesth Analg. 2008 Jan;106(1):270-7, table of contents. doi: 10.1213/01.ane.0000289635.95869.70.
• Background Ra JY, An S, Lee GH, Kim TU, Lee SJ, Hyun JK. Skin temperature changes in patients with unilateral lumbosacral radiculopathy. Ann Rehabil Med. 2013 Jun;37(3):355-63. doi: 10.5535/arm.2013.37.3.355. Epub 2013 Jun 30.
• Background Safarpour D, Jabbari B. Botulinum toxin A (Botox) for treatment of proximal myofascial pain in complex regional pain syndrome: two cases. Pain Med. 2010 Sep;11(9):1415-8. doi: 10.1111/j.1526-4637.2010.00929.x. Epub 2010 Aug 23.
• Background Safarpour D, Salardini A, Richardson D, Jabbari B. Botulinum toxin A for treatment of allodynia of complex regional pain syndrome: a pilot study. Pain Med. 2010 Sep;11(9):1411-4. doi: 10.1111/j.1526-4637.2010.00897.x. Epub 2010 Jun 30.
• Background Shahidi B, Johnson CL, Curran-Everett D, Maluf KS. Reliability and group differences in quantitative cervicothoracic measures among individuals with and without chronic neck pain. BMC Musculoskelet Disord. 2012 Oct 31;13:215. doi: 10.1186/1471-2474-13-215.

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Indications