Intra-sheath vs Extra-sheath Injection for De Quervain's Tenosynovitis
试验速览
- 阶段
- 4 期
- 状态
- 招募中
- 入组人数
- 80
- 试验地点
- 1
- 主要终点
- Visual analog scale (VAS) at 6 weeks post injection
研究概览
简要总结
The aim of the study is to determine whether or not extra-sheath steroid injections are inferior to intra-sheath steroid injections in the treatment of DeQuervain's Tenosynovitis.
Patients will be randomized to either the intra-sheath group or the extra-sheath group and their pre-injection level of pain will be assessed using the visual analog scale. Appropriate injections will then be administered by 1 of 3 UC Davis hand surgeons. Six weeks post injection the patients will be reassessed using the visual analog scale and their score at 6 weeks will be compared to their pre-injection score.
详细描述
Null Hypothesis: Extra-sheath steroid injections are inferior to intra-sheath steroid injections in the treatment of DeQuervain's tenosynovitis.
Alternative Hypothesis:Extra-sheath steroid injections are not inferior to intra-sheath steroid injections in the treatment of De Quervain's tenosynovitis.
Background:
DeQuervain's Tenosynovitis is a common condition with an estimated incidence of 0.5% in men and 1.3% in women, usually occurring in the third or fourth decade of life. The condition involves accumulation of mucopolysaccharide in the first dorsal compartment of the wrist, narrowing the passageway through which the abductor pollicis longus (APL) and extensor pollicis brevis (EPB) tendons pass(1). Patients typically present with pain over the radial styloid that is often exacerbated by grasping, thumb abduction and ulnar deviation of the wrist. The degree of pain can be measured using the visual analog scale (VAS).
The VAS pain scale is a widely used test to effectively measure pain(9). The visual analog scale we will be using is a 100mm horizontal line with no numbers and only written descriptors on either end of the line. The written descriptor on the left side of the line will be "no pain" and the descriptor on the right will be "pain as bad as it could possibly be". Patients will be instructed to make a mark on the line where they believe their current pain fits. The patient's response will be measured and recorded.
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, Care Provider)
盲法说明
Participants will not be informed which arm of the trial they have been placed in until after the conclusion of their involvement with the study. To ensure blinding of the physicians, follow up assessments will not be performed by the doctors who administered the injection and will instead be performed by residents who will not be informed which group the patient has been placed in.
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
- •Signed informed consent from the patient exclusively and not a legal representative
- •Clinically diagnosed with De Quervain's
- •VAS score of at least 40mm pre-injection
- •Life expectancy greater than 1 year
排除标准
- •Having previously undergone steroid injection in the treatment of De Quervain's
- •Having previously undergone surgery for De Quervain's in the affected wrist
- •Having previously undergone steroid injection and failed in the treatment of trigger finger
- •Allergies to lidocaine or dexamethasone
- •Underlying serious medical conditions that would place the patient at risk
- •Past history of hypothyroidism or rheumatoid arthritis
- •Pregnant women
- •Prisoners
研究组 & 干预措施
Intra-sheath injection
In patients randomized to the intra-sheath, corticosteroids will be injected directly into the abductor pollicis longus/ extensor pollicis brevis sheath.
干预措施: Intra-sheath injection (Procedure)
Intra-sheath injection
In patients randomized to the intra-sheath, corticosteroids will be injected directly into the abductor pollicis longus/ extensor pollicis brevis sheath.
干预措施: Ultrasound (Device)
Extra-sheath injection
In patients randomized to the extra-sheath arm, corticosteroids will be injected surrounding the abductor pollicis longus/ extensor pollicis brevis sheath.
干预措施: Extra-sheath injection (Procedure)
Extra-sheath injection
In patients randomized to the extra-sheath arm, corticosteroids will be injected surrounding the abductor pollicis longus/ extensor pollicis brevis sheath.
干预措施: Ultrasound (Device)
结局指标
主要结局
Visual analog scale (VAS) at 6 weeks post injection
时间窗: 6 weeks
The difference between pre-injection and 6 weeks post-injection visual analog scale scores in both the experimental extra-sheath injection and control intra-sheath injection. The visual analog pain scale is a widely used test to effectively measure pain(9). The visual analog scale we will be using is a 100mm horizontal line with no numbers and only written descriptors on either end of the line. The written descriptor on the left side of the line will be "no pain" and the descriptor on the right will be "pain as bad as it could possibly be". Patients will be instructed to make a mark on the line where they believe their current pain fits. The patient's response will be measured and recorded.
次要结局
- Visual analog scale (VAS) at 6 months post injection(6 months)
- Visual analog scale (VAS) at 1 year post injection(1 year)
- Shortened disabilities of the hand arm and shoulder (quickDASH) scores at 1 year post injection(1 year)
- Shortened disabilities of the hand arm and shoulder (quickDASH) scores at 6 week post injection(6 weeks)
- Shortened disabilities of the hand arm and shoulder (quickDASH) scores at 6 months post injection(6 months)
- Presence or absence of separate abductor pollicis longus and extensor pollicis brevis subsheaths(1 year)