Betamethason Versus Ketorolac Injection for the Treatment of DeQuervains Tenosynovitis
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 入组人数
- 64
- 试验地点
- 1
- 主要终点
- Visual analog scale (VAS) of pain with finklestein test
研究概览
简要总结
The purpose of this study is to determine if corticosteroid injection modifies the natural course of de Quervain tendinopathy compared to a toradol injection.
详细描述
If steroids are effective for Dequervain tenosynovitis because of their anti-inflammatory properties, then there is a reasonable and rational argument to be made for the local injection of NSAIDS (non-steroidal anti-inflammatory drugs) into the first dorsal extensor compartment. Ketorolac is an NSAID that has been proven efficacious in the treatment of another musculoskeletal condition. Moreover, compared to betamethasone (or other injectable corticosteroids), injection of ketorolac decreases the patient exposure to the potential side-effects of corticosteroids, especially that of elevation of blood sugar levels in diabetics.
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
- •Diagnosis of DeQuervain tendinopathy
- •Understands the local language and is willing and able to follow the requirements of the protocol
- •Understands the informed consent and signs the institutional review board/independent ethics committee (IRB/IEC) approved informed consent form
排除标准
- •Patients who have an allergy to lidocaine, celestone, or ketorolac, nonsteroidal anti-inflammatory drugs (NSAIDs), or acetylsalicylic acid (ASA)
- •Patients who have an adverse reaction to lidocaine, celestone, or ketorolac (such as severe elevation of blood sugars in diabetics that caused medical complication)
- •Patients who have received a prior steroid injection within the past three months
- •Patients who have had a prior ipsilateral surgery for DeQuervain Tenosynovitis
- •Patients that have a skin lesion at the location of injection (such as trauma, eczema, rash)
- •Patients who have a current infection at the location of injection
- •Patients who have had iontophoresis within three months
- •Patients who are breast feeding, pregnant, or who plan to become pregnant in the next six months
研究组 & 干预措施
Betamethasone
1 cc of 1% lidocaine (without epinephrine) plus 1 cc of 6 mg/ml betamethasone (Celestone)
干预措施: betamethasone (Drug)
Ketorolac
1 cc of 1% lidocaine (without epinephrine) plus 1 cc of 30 mg/ml of ketorolac (Toradol)
干预措施: Ketorolac (Drug)
结局指标
主要结局
Visual analog scale (VAS) of pain with finklestein test
时间窗: 6 weeks post injection
Visual Analog Scale (VAS) of pain measured on 0 (no pain) - 10 (worst possible pain)
次要结局
- Grip Strength(pre injection, 2 weeks post injection, 6 weeks post injection)
- Visual analog scale (VAS) of pain with tenderness over tendon(pre injection, 2 weeks post injection, 6 weeks post injection)
- Visual analog scale (VAS) of pain on radial side of wrist(pre injection, 2 weeks post injection, 6 weeks post injection, 3 months post injection, 6 month post injection)
- The Disabilities of the Arm, Shoulder, and Hand Score (DASH)(pre injection, 2 weeks post injection, 6 weeks post injection, 3 months post injection, 6 months post injection)
- Veterans-Rand 12 (VR-12)(pre injection, 2 weeks post injection, 6 weeks post injection, 3 months post injection, 6 months post injection)
- Pinch Strength(pre-injection, 2 weeks post injection, 6 weeks post injection)