Phase 2 Study - The Use of a Single 5 mg Dose of Zoledronic Acid in Complex Regional Pain Syndrome Patient.
试验速览
- 阶段
- 2 期
- 入组人数
- 40
- 试验地点
- 1
- 主要终点
- Pain measured on Visual Analog Scale
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Double (Participant, Investigator)
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients over 18 years of age of both genders, with continuing pain that is disproportionate to any inciting event, with cardinal features of CRPS.
- •Pain - after initial injury with signs and symptoms present at first visit
- •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.
- •Must report at least one symptom in three of the four following categories:
- •Sensory: Reports of hyperesthesia and/or allodynia
- •Vasomotor: Reports of temperature asymmetry and/or skin color changes and/or skin color asymmetry
- •Sudomotor/Edema: Reports of edema and/or sweating changes and/or sweating asymmetry
- •Motor/Trophic: Reports of decreased range of motion and/or motor dysfunction (weakness, tremor, dystonia) and/or trophic changes (hair, nail, skin).
- •Must display at least one sign* at time of evaluation in two or more of the following categories:
- •Sensory: Evidence of hyperalgesia (to pinprick) and/or allodynia (to light touch and/or deep somatic pressure and/or joint movement)
- •Vasomotor: Evidence of temperature asymmetry and/or skin color changes and/or asymmetry
- •Sudomotor/Edema: Evidence of edema and/or sweating changes and/or sweating asymmetry
- •Motor/Trophic: Evidence of decreased range of motion and/or motor dysfunction (weakness, tremor, dystonia) and/or trophic changes (hair, nail, skin).
- •Skin temperature of the affected side equal or higher than on the non-affected side.
- •No other diagnosis better explains the signs and symptoms.
排除标准
- •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.
- •Creatinine clearance <35mL/min, with serum creatinine measured before the dose of zoledronic acid.
- •Pre-existing hypocalcaemia and disturbance of mineral metabolism (e.g. hyperparathyroidism, thyroid surgery, parathyroid surgery, malabsorption syndromes, and excision of small intestine).
- •Hypersensitivity to zoledronic acid or any component drugs used in the trial.
- •Patients with asthma and aspirin-sensitivity
- •Pregnancy or unwillingness to use contraceptive methods during the trial
- •Patients who have previously used any kind of bisphosphonate, especially zoledronic acid.
- •Osteoporosis
研究组 & 干预措施
Saline
One single intravenous infusion of 100ml of saline (placebo control group).
干预措施: Placebo (Drug)
Zoledronic acid
one single dose of 5mg intravenous infusion of zoledronic acid (interventional group)
干预措施: Zoledronic acid (Drug)
结局指标
主要结局
Pain measured on Visual Analog Scale
时间窗: up to 12 months after treatment
次要结局
- Lower Limbs vertical force on Wii platform(Baseline, 3, 6 and 12 months)
- American Orthopaedic Foot and Ankle Scale (AOFAS)(Baseline, 3, 6 and 12 months after treatment)
- 36-Item Short Form Health Survey (SF-36)(Baseline, 3, 6 and 12 months after treatment)
研究者
Pérola Grinberg Plapler
MD, PhD, Director of Physical Medicine Division Of Institute Orthopedics and Traumatology of University of Sao Paulo General Hospital
University of Sao Paulo General Hospital