Comparison of efficacy and safety of Prednisolone 20 mg vs Placebo in Diabetic patients with Complex Regional Pain Syndrome of upper extremity
试验速览
- 阶段
- 3 期
- 状态
- 招募中
- 发起方
- 入组人数
- 40
- 试验地点
- 1
- 主要终点
- Reduction in VAS score ≥ 50%
研究概览
简要总结
The Diabetes mellitus (DM) has 5 time more incidence of CRPS/Frozen shoulder leading to pain, restricted shoulder movement and hampering self-care. There are limited studies on the role of corticosteroids in frozen shoulder associated with DM patients. In our earlier studies post stroke CRPS oral prednisolone reduces pain and improved range of movements substantially compared to Piroxicam . We have also found prednisolone 40 mg and 20 mg equally effective in CRPS-I. In that study prednisolone 20 mg resulted in increased blood glucose in 24% which could be easily controlled with augmentation of drug, without withdrawal from the study. In this study we will include well controlled DM with HbA1C<8 %, without any ocular, cardiac and renal complication. The result of the proposed study likely to give an evidence whether prednisolone 20 mg is safe and effective in DM associated CRPS I.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 盲法
- None
入排标准
- 年龄范围
- 18.00 Year(s) 至 70.00 Year(s)（—）
- 性别
- All
入选标准
- •A) Continuous pain which is disproportionate to any inciting factor.
- •B) At least one symptom in three of the four following domains.
- •Sensory: hyperesthesia with or without allodynia.
- •Vasomotor: Asymmetry in temperature or skin color, skin color changes of the affected limb.
- •Sudomotor/edema: Presence of edema, sweating changes or sweating asymmetry.
- •Motor/ trophic: Reduced range of motion or motor dysfunction with or without trophic changes of the limb.
- •Sensory: Hyperalgesia (to pin prick) with or without allodynia (light touch, deep somatic presence or joint movements).
- •Vasomotor: Evidence of temperature or skin color asymmetry, or skin color changes.
- •Motor or trophic: Evidence of deduced range of movement, motor dysfunction (weakness, dystonia or tremor) and or trophic changes in nail, skin or hair.
- •No other diagnosis could explain the symptoms or signs.
排除标准
- •Patients with uncontrolled hypertension, diabetes, infection, organ failure, malignancy, shoulder joint dislocation or infection, pregnancy and unwilling for consent will be excluded.
结局指标
主要结局
Reduction in VAS score ≥ 50%
时间窗: One Month
次要结局
- CRPS total score, and its different domains, HADS score, DISS score and side effects.(One month)
研究者
Dr Jayantee Kalita
Sanjay Gandhi Post Graduate Institute of Medical Sciences