The Use of Zoledronic Acid to Complex Regional Pain Syndrome
Information source: University of Sao Paulo General Hospital
ClinicalTrials.gov processed this data on August 23, 2015 Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Complex Regional Pain Syndromes
Intervention: Zoledronic acid (Drug); Placebo (Drug)
Phase: Phase 2
Status: Not yet recruiting
Sponsored by: University of Sao Paulo General Hospital Official(s) and/or principal investigator(s): Linamara R. Battistella, PHD, Study Director, Affiliation: Centro de Pesquisa Clínica do Instituto de Medicina Física e de Reabilitação do Hospital das Clínicas da FMUSP
Overall contact: Perola Grinberg Plapler, MD, Phone: 55 11 39058512, Email: perolagp@yahoo.com
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.
Clinical Details
Official title: Phase 2 Study - The Use of a Single 5 mg Dose of Zoledronic Acid in Complex Regional Pain Syndrome Patient.
Study design: Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment
Primary outcome: Pain measured on Visual Analog Scale
Secondary outcome: Lower Limbs vertical force on Wii platformAmerican Orthopaedic Foot and Ankle Scale (AOFAS) 36-Item Short Form Health Survey (SF-36)
Detailed description:
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.
Eligibility
Minimum age: 18 Years.
Maximum age: N/A.
Gender(s): Both.
Criteria:
Inclusion Criteria:
1. Patients over 18 years of age of both genders, with continuing pain that is
disproportionate to any inciting event, with cardinal features of CRPS.
2. Pain - after initial injury with signs and symptoms present at first visit
3. History of previous unsuccessful treatment for pain, with a minimum of two drug
therapies, such as non steroidal anti-inflammatory drugs, steroids, antidepressants,
central acting analgesics, calcitonin or sympathetic blocks, (not bisphosphonates)
for at least six months.
4. Must report at least one symptom in three of the four following categories:
1. Sensory: Reports of hyperesthesia and/or allodynia
2. Vasomotor: Reports of temperature asymmetry and/or skin color changes and/or
skin color asymmetry
3. Sudomotor/Edema: Reports of edema and/or sweating changes and/or sweating
asymmetry
4. Motor/Trophic: Reports of decreased range of motion and/or motor dysfunction
(weakness, tremor, dystonia) and/or trophic changes (hair, nail, skin).
5. Must display at least one sign* at time of evaluation in two or more of the following
categories:
1. Sensory: Evidence of hyperalgesia (to pinprick) and/or allodynia (to light touch
and/or deep somatic pressure and/or joint movement)
2. Vasomotor: Evidence of temperature asymmetry and/or skin color changes and/or
asymmetry
3. Sudomotor/Edema: Evidence of edema and/or sweating changes and/or sweating
asymmetry
4. Motor/Trophic: Evidence of decreased range of motion and/or motor dysfunction
(weakness, tremor, dystonia) and/or trophic changes (hair, nail, skin).
6. Skin temperature of the affected side equal or higher than on the non-affected side.
7. No other diagnosis better explains the signs and symptoms.
Exclusion Criteria:
1. Presence of systemic diseases including diabetes mellitus, hyperthyroidism, renal and
liver dysfunction, peripheral vascular or cardiovascular diseases, uncontrolled
hypertension, rheumatoid and hematopoietic diseases, neurological diseases not
related to CRPS, overt alcohol addiction, positive pregnancy test and/or lactating
women, hyperparathyroidism, and hypocalcaemia.
2. Creatinine clearance <35mL/min, with serum creatinine measured before the dose of
zoledronic acid.
3. Pre-existing hypocalcaemia and disturbance of mineral metabolism (e. g.
hyperparathyroidism, thyroid surgery, parathyroid surgery, malabsorption syndromes,
and excision of small intestine).
4. Hypersensitivity to zoledronic acid or any component drugs used in the trial.
5. Patients with asthma and aspirin-sensitivity
6. Pregnancy or unwillingness to use contraceptive methods during the trial
7. Patients who have previously used any kind of bisphosphonate, especially zoledronic
acid.
8. Osteoporosis
Locations and Contacts
Perola Grinberg Plapler, MD, Phone: 55 11 39058512, Email: perolagp@yahoo.com
Centro de Pesquisa Clínica do Instituto de Medicina e Reabilitação do HCFMUSP, São Paulo 05716-150, Brazil; Not yet recruiting Pérola G Plapler, MDPhD, Phone: 55 11 39058512, Email: perolagp@yahoo.com Marta Imamura, MDPhD, Phone: 55 11 39058512, Email: martaimf3@gmail.com Pérola G. Plapler, MDPhD, Principal Investigator
Additional Information
Starting date: December 2013
Last updated: February 8, 2013
|