To evaluate the efficacy and the safety of using a single, intravenous 5mg dose of zoledronic acid in managing pain in Complex Regional Pain Syndrome patients.
Complex regional pain syndrome (CRPS) is a disorder of the extremities that is characterized by spontaneous unexplained disproportionate pain, hyperalgesia, swelling, limited range of motion, vasomotor instability, skin changes, and patchy bone demineralization.The incidence of CRPS was estimated to be 5.46 per 100,000 person years at risk in Olmsted County, Minnesota (US), with a prevalence of 20.57 per 100,000, while its incidence in the general population of the Netherlands was estimated to be much higher, at 26.2 per 100,000 person-years. The adverse effects were not serious and lasted just a few days. The beneficial effects of other bisphosphonates have been already documented in several placebo-controlled trials; however, there are no reports on the use of zoledronic acid to reduce pain in CRPS patients.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Enrollment
40
One single dose of 5mg intravenous infusion of zoledronic acid (interventional group)
one single intravenous infusion of 100ml of saline.
Centro de Pesquisa Clínica do Instituto de Medicina e Reabilitação do HCFMUSP
São Paulo, São Paulo, Brazil
Pain measured on Visual Analog Scale
Time frame: up to 12 months after treatment
Lower Limbs vertical force on Wii platform
Time frame: Baseline, 3, 6 and 12 months
American Orthopaedic Foot and Ankle Scale (AOFAS)
Time frame: Baseline, 3, 6 and 12 months after treatment
36-Item Short Form Health Survey (SF-36)
Time frame: Baseline, 3, 6 and 12 months after treatment
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