Pain With Trigger Finger Injection: A Comparison of Steroid Alone Versus Steroid/Lidocaine Mixture
试验速览
- 阶段
- 4 期
- 状态
- 终止
- 发起方
- 入组人数
- 26
- 试验地点
- 1
- 主要终点
- VAS
研究概览
简要总结
This research is being done to compare pain relief and efficacy of trigger finger injection using a combination of lidocaine/corticosteroid versus corticosteroid injection alone versus corticosteroid/saline combination.
详细描述
This is a prospective, randomized study comparing pain relief and efficacy of trigger finger injection using a combination of lidocaine/corticosteroid versus corticosteroid injection alone versus corticosteroid/saline combination.
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
- Single (Participant)
入排标准
- 年龄范围
- 18 Years 至 90 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age 18-90
- •Male or female (non-pregnant)
- •Clinically diagnosed trigger digit
- •Subject is able to provide voluntary, written informed consent
- •Subject, in the opinion of the clinical investigator, is able to understand the clinical investigation and is willing to perform all study procedures and follow-up visits.
排除标准
- •Age <18 or >90
- •Pregnant or lactating women
- •Non-English speaking individuals
- •Medication contradictions to lidocaine, corticosteroids and/or saline
- •Prior injection or surgery on the affected finger
- •Diagnosis of reflex symptomatic dystrophy (RSD) or complex regional pain syndrome (CRPS)
- •Open wound
研究组 & 干预措施
Corticosteroid/Saline (CSS) Group
1 cc dexamethasone sodium phosphate (4mg/ml) injectable and 1 cc 0.9% injectable Sodium Chloride (saline)
干预措施: Dexamethasone Sodium Phosphate (Drug)
Corticosteroid alone (CS) Group
1 cc dexamethasone sodium phosphate (4mg/ml) injectable
干预措施: Dexamethasone Sodium Phosphate (Drug)
Corticosteroid/Lidocaine (CSL) Group
1 cc dexamethasone sodium phosphate (4 mg/ml) injectable and 1 cc 1% Xylocaine (lidocaine) injectable
干预措施: Dexamethasone Sodium Phosphate (Drug)
Corticosteroid/Lidocaine (CSL) Group
1 cc dexamethasone sodium phosphate (4 mg/ml) injectable and 1 cc 1% Xylocaine (lidocaine) injectable
干预措施: Xylocaine (Drug)
Corticosteroid/Saline (CSS) Group
1 cc dexamethasone sodium phosphate (4mg/ml) injectable and 1 cc 0.9% injectable Sodium Chloride (saline)
干预措施: Sodium Chloride (Drug)
结局指标
主要结局
VAS
时间窗: Patients are assessed pre-injection (baseline), 1 minute post-injection, 10 minutes post-injection, at 6 weeks post-injection and also asked to recollect their pain at time of injection when seen at 6 weeks post-injection
Visual Analogue Pain Scale (VAS) - measurement of pain on scale of 0 (least) to 10 (worst).
次要结局
- Number of Participants With Adverse Effects(Patients are assessed 1 minute post-injection, 10 minutes post-injection, and at 6 week post-injection.)
- Presence of Triggering(Patients are assessed pre-injection (baseline), 1 minute post-injection, 10 minutes post-injection, and 6 weeks post-injection)
- Degree of Triggering(Patients are assessed pre-injection objectively by investigator and at 6 weeks post-injection subjectively via Patient Survey)
研究者
Kenneth Taylor, M.D.
Associate Professor, Orthopaedics
Milton S. Hershey Medical Center