Clinical Trial: The Use of Zoledronic Acid to Complex Regional Pain Syndrome

Study Status: Recruiting
Recruit Status: Unknown status
Study Type: Interventional

Official Title: Phase 2 Study - The Use of a Single 5 mg Dose of Zoledronic Acid in Complex Regional Pain Syndrome Patient.

Brief Summary: 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.

Detailed Summary: 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.
Sponsor: University of Sao Paulo General Hospital

Current Primary Outcome: Pain measured on Visual Analog Scale [ Time Frame: up to 12 months after treatment ]

Original Primary Outcome: Same as current

Current Secondary Outcome:

  • 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 ]


Original Secondary Outcome: Same as current

Information By: University of Sao Paulo General Hospital

Dates:
Date Received: October 9, 2012
Date Started: December 2013
Date Completion: December 2016
Last Updated: February 8, 2013
Last Verified: February 2013