Comparative Efficacy of Triamcinolone Acetonide 40mg and Triamcinolone Hexacetonide 20mg for Symptom-free Interval in Lateral Epicondylitis: A Double blind, Randomized controlled trial.
试验速览
- 阶段
- 4 期
- 状态
- 尚未招募
- 发起方
- 入组人数
- 84
- 试验地点
- 1
- 主要终点
- PRIMARY OUTCOME
研究概览
简要总结
Lateral epicondylitis, one of the most common clinically diagnoses elbow disorders is a self limiting condition with a long disease duration. Which is why intervention is commonly given which includes both pharmacological and non pharmacological methods one of which is a steroid injection. Most commonly used steroid is Triamcinolone acetonide which is being compared to Triamcinolone Hexacetonide in this study. Reasen for the use of Triamcinolone Hexacetonide is thta is it more lipophilic and has a lower aqueous solubility so leads to slower absorption from the injection site.
The primay objective of this study is to confirm the duration of symptom free period after initial pain relief. The secondary objective is to assess the hand strength and adverse effects between the two treatment groups.
Study will be conducted by the department of phamacology in collaboration with the department of Physical medicine and rehabilitation. It is a prospective, randomized, Double blind, Parallel, Two-armed controlled study.
Sample size used is 84 patients with lateral epicondylitis for a study duration of 6 months each.
Inclusion Criteria:
1. Patients of either gender aged between 18 to 60 years.
2. Tenderness on palpation of Lateral epicondyle and the extensor unit.
3. Pain at the effected site on gripping hand dynamometer at any pressure.
4. Pain on contraction of wrist extensors using Cozen test.
5. Symptoms of >= 6 weeks duration.
Exclusion Criteria:
1. History of surgery or trauma to the effected elbow.
2. History of corticosteroid injection in past 6 months.
3. Co-existing systemic conditions like rheumatoid arthritis and other Auto-immune diseases, Uncontrolled diabetes mellitus.
4. Ongoing local or systemic infection.
5. Pregnant or lactating women.
6. History of psychiatric diseases.
7. Any previous drug reaction to corticosteroids.
There will be 4 visits where screeign and informed consent will be taken on Visit 1, intervantion will be given on visit 2 and the VAS, PRTEE and dynamometre reading will be taken on Visit 2,3 and 4.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 盲法
- Participant and Investigator Blinded
入排标准
- 年龄范围
- 18.00 Year(s) 至 60.00 Year(s)（—）
- 性别
- All
入选标准
- •1.Tenderness on palpation of lateal epicondyle and extensor unit
- •Pain at the effected site on gripping hand dynamometer at any pressure 3.Pain on contraction of wrist extensors using cozens test.
- •Symptoms of greater then 6 weeks duration.
排除标准
- •History of surgery or trauma to the effected elbow.
- •History of corticosteroid injection in past 6 months.
- •Co-existing systemic conditions like rheumatoid arthritis and other Auto-immune diseases, Uncontrolled diabetes mellitus.
- •Ongoing local or systemic infection.
- •Pregnant or lactating women.
- •History of psychiatric diseases.
- •Any previous drug reaction to corticosteroids.
结局指标
主要结局
PRIMARY OUTCOME
时间窗: VISIT 1( WEEK -1) | VISIT 2( WEEK 1) | VISIT 3(WEEK 12) | VISIT 4(WEEK 24)
1. To assess the return or increase in pain on follow up
时间窗: VISIT 1( WEEK -1) | VISIT 2( WEEK 1) | VISIT 3(WEEK 12) | VISIT 4(WEEK 24)
2. To asses level of pain using VAS
时间窗: VISIT 1( WEEK -1) | VISIT 2( WEEK 1) | VISIT 3(WEEK 12) | VISIT 4(WEEK 24)
3. To assess level of pain using PRTEE Questionnaire
时间窗: VISIT 1( WEEK -1) | VISIT 2( WEEK 1) | VISIT 3(WEEK 12) | VISIT 4(WEEK 24)
次要结局
- 1. Grip strength using hand dynamometer measured at visit 2,3 and 4(2. Compare the incidence of adverse effects at visit 3 and 4)
研究者
aeliya fatima
ESIC Medical College and Hospital