跳至主要内容
临床试验/NCT00983177
NCT00983177Unknown不适用

Colchicine Treatment for Chronic Shoulder Pain Related to Calcific Tendonitis: Double Blind Placebo-controlled Study

Bnai Zion Medical Center1 个研究点 分布在 1 个国家目标入组 80 人开始时间: 2010年3月最近更新:
适应症
干预措施
相关药物

试验速览

阶段
不适用
入组人数
80
试验地点
1
主要终点
VAS for shoulder pain

研究概览

简要总结

Chronic pain due to calcific tendonitis of shoulder is a prevalent condition usually treated with recurrent courses of NSAIDs, physical therapy or surgical interventions. Colchicine has been reported to be effective in the acute attack of shoulder tendonitis, however, has never been examined in controlled study in patients with chronic shoulder pain secondary to calcific tendonitis. Eighty patients with chronic shoulder pain (at least 3 months duration) due to calcific tendonitis will be randomized to receive colchicine 0.5 mg twice daily or placebo (lactose capsules) for 4 months. At the end of this blinded part of the study, patients who received placebo and did not improve, will be eligible to continue study in the open mode for additional 4 months with study drug. Efficacy (VAS for shoulder pain, shoulder range of motion and shoulder pain and disability index) and safety (blood tests) follow-ups will be scheduled bi-monthly for all 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
Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)

入排标准

年龄范围
18 Years 至 —(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • chronic, more than 3 months duration, shoulder pain
  • tendinous calcifications on shoulder X-rays

排除标准

  • renal insufficiency
  • liver insufficiency
  • lactose intolerance
  • hypersensitivity to colchicine

研究组 & 干预措施

colchicine

Active Comparator

干预措施: Colchicine (Drug)

Lactose capsule

Placebo Comparator

干预措施: lactose (Drug)

结局指标

主要结局

VAS for shoulder pain

时间窗: 4-8 months

shoulder range of motion

时间窗: 4-8 months

shoulder pain and disability index

时间窗: 4-8 months

次要结局

未报告次要终点

研究者

申办方类型
Other Gov

研究点 (1)

Loading locations...

相似试验