Effect of Vitamin D3 Combined With Extensor Muscle Strengthening Exercise in Lateral Epicondylitis of Elbow: a Randomized Controlled Trial
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 100
- 试验地点
- 1
- 主要终点
- visual analog scale of pain (VAS)
研究概览
简要总结
The goal of this study is to verify the effect of vitamin D3 combined with extensor muscle strengthening exercise in lateral epicondylitis of elbow Are there significant differences in the improvement of functional scores between the study and control groups? Are there significant differences in the improvement of sonographic findings and blood D3 levels between the study and control groups? Participant will underwent D3 injection or saline injection and extensor muscle strengthening exercise with counter force brace. All the participant will undergo functional scoring, sonographic examination and blood D3 level testings until 6 months after initial visit.
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)
盲法说明
An independent nurse uses a random sequence generator and allocates the participants into the two groups. Participant, investigator and outcomes assessor were blinded of participants' information
入排标准
- 年龄范围
- 20 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •lateral epicondylitis(LE) of elbow symptoms that persisted of increased for more than 3 months in which LE was defined as pain on the lateral side of the elbow and pain at the lateral epicondyle upon direct palpation and during resisted dorsiflexion of the wrist
排除标准
- •younger than 20 years
- •history of ipsilateral elbow surgery
- •common extensor tendon tears more than 30% in depth
- •inflammatory diseases (rheumatoid arthritis, psoriatic arthritis, etc)
- •osteoarthritis with a limitation of range of motion (flexion contracture >30 degree and further flexion < 100 degree)
- •neurological deficits in the ipsilateral upper limb,and follow-ups less than 24 weeks
研究组 & 干预措施
Vitamin D3 injection
1.0mL Vitamin D3 injection at ilsilateral deltoid muscle and extensor muscle strengthening exercise with counter force brace in lateral epicondylitis of elbow
干预措施: Vitamin D3 or Saline injection at ipsilateral deltoid muscle (Drug)
Saline injection
1.0mL saline injection at ilsilateral deltoid muscle and extensor muscle strengthening exercise with counter force brace in lateral epicondylitis of elbow
干预措施: Vitamin D3 or Saline injection at ipsilateral deltoid muscle (Drug)
结局指标
主要结局
visual analog scale of pain (VAS)
时间窗: initial, Week 4, 12, 24
0-10, 0: no pain, 10: very severe pain
次要结局
- Patient's satisfaction(initial, Week 4, 12, 24)
- Mayo Elbow Performance Score (MEPS)(initial, Week 4, 12, 24)
- Grip power (attected/nonaffected)(initial, Week 4, 12, 24)
- plasma Vitamin D level(initial, Week 4, 12, 24)
- sonographic evaluation(initial, Week 4, 12, 24)
研究者
Jung-Taek Hwang
Professor
Chuncheon Sacred Heart Hospital