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临床试验/NCT02038634
NCT02038634终止4 期

Ultrasound-guided Injection for DeQuervain's

Medical College of Wisconsin1 个研究点 分布在 1 个国家目标入组 16 人开始时间: 2014年8月5日最近更新:
适应症
干预措施
相关药物

试验速览

阶段
4 期
状态
终止
入组人数
16
试验地点
1
主要终点
DASH - "Disabilities of the Arm, Shoulder, and Hand" Score At Baseline, and Change From Baseline at 6-8 Weeks, 12-16 Weeks, and at 1 Year

研究概览

简要总结

The investigators aim to perform a prospective study to evaluate the effectiveness of blind corticosteroid injections to US-guided injections for the treatment of de Quervain's disease. The results of the study will be used to validate current injection protocols or support the incorporation of ultrasonography to treat the disease.

详细描述

De Quervain's disease is the stenosing tenosynovitis and tendinitis of the abductor pollicis longus (APL) and extensor pollicis brevis (EPB) tendons in the first dorsal compartment of the wrist. While the prevalence of de Quervain's is not yet well-established, previous studies have shown that women can be affected by the disease up to six times more frequently than men. Conservative treatments include splinting and corticosteroid injections, but surgery is an option when such therapy fails. There has been a previous study that compared the improvement rates of patients treated with splinting alone, injection and splinting, and injection alone, and found the rate of improvement to be 19%, 57%, 67%, respectively. This confirmed the good results reported in previous studies and recommends corticosteroid injection to clinicians as a reliable treatment for de Quervain's disease.

A seminal study performed correlated the accuracy of corticosteroid injection with pain relief by including X-ray dye in the injection. The results of the study suggested a strong correlation between accurate injection of the first dorsal compartment and pain relief. Since then, the use of ultrasonography (US) to guide steroid injection has been suggested as a possible clinical practice, but little research has been done on the technique. A 2009 study reported a 93.75% rate of significant pain relief after the use of US-guided injections, but there was no control group with which to compare results. The current standard practice for steroid injection in de Quervain's patients is a blind injection without imaging guidance. To the investigators knowledge, no study has compared the accuracy and clinical outcomes of blind injections to US-guided injections. The investigators hypothesize that the US-guided injections will be and will result in greater pain relief for patients than blind injections.

This is intended to be a prospective study. Patients will contact Dr.'s Grindel and Daley for a standard clinical evaluation, which includes palpation of the first extensor compartment and application of the Finkelstein test. Those diagnosed with de Quervain's disease and who fit all inclusion criteria will receive a detailed verbal description of the study from one of the doctors, who will then attain written, informed consent from willing participants. Dr.'s Grindel or Daley will then administer either a blind or US-guided injection. The patient will return for follow-up appointments at 6-8 weeks and 12-16 weeks and will undergo another physical exam to determine pain relief. A phone call follow-up will also be placed one year after the injection in order to determine long-term effectiveness. Once 20 study subjects in each group (40 total) have been enrolled and completed treatment, the data will undergo statistical analysis.

This study poses minimal or no physical risk to study subjects, as the US-guided injection should show better pain relief for patients than the current standard treatment (blind injection).

In summary, the investigators aim to perform a prospective study to evaluate the effectiveness of blind corticosteroid injections to US-guided injections for the treatment of de Quervain's disease. The results of the study will be used to validate current injection protocols or support the incorporation of ultrasonography to treat the disease.

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
None

入排标准

年龄范围
18 Years 至 —(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Pain with palpation at 1st dorsal compartment at wrist and positive Finkelstein's Test

排除标准

  • Patients with evidence of osteoarthritis or degeneration of the wrist.

研究组 & 干预措施

Unguided injections

Active Comparator

Corticosteroid injection (betamethasone) without ultrasound guidance.

干预措施: Betamethasone (Drug)

Ultrasound-guided injections

Active Comparator

Corticosteroid injections (betamethasone) under ultrasound guidance.

干预措施: Betamethasone (Drug)

Ultrasound-guided injections

Active Comparator

Corticosteroid injections (betamethasone) under ultrasound guidance.

干预措施: Ultrasound (Device)

结局指标

主要结局

DASH - "Disabilities of the Arm, Shoulder, and Hand" Score At Baseline, and Change From Baseline at 6-8 Weeks, 12-16 Weeks, and at 1 Year

时间窗: Prior to injection (Dash #1), 6-8 weeks (Dash #2), 12-16 weeks (Dash #3), and 1 year (Dash #4) post-injection

Disabilities of the Arm, Shoulder, and Hand (DASH) Questionnaire. Questions 1-30, the scale is a 1-5 scale (1=no difficulty; 2=mild difficulty; 3=moderate difficulty; 4=severe difficulty; 5=unable) DASH Disability/Symptom Score = \[(sum of n responses)/n) -1\] x 25. A lower score is a better outcome. The Dash is based on a scale of 0-100. Our scores were averaged and the Mean scores are what we reported. Total scores are listed below. US Guided Group - Dash #1 (Min=25, Mean=58, Max=90) n=12; Dash #2 (Min=3, Mean=38, Max=91) n=12; Dash #3 (Min=6, Mean=42, Max=71) n=10; 1 Year Dash (Min=0, Mean =29, Max=91) n=12. Non-US Guided Group - Dash #1 (Min=23, Mean=39, Max=61) n=3; Dash #2 (Min=0, Mean=11, Max=22) n=3; Dash #3 (Min=7, Mean=30, Max=49) n=3; 1 Year Dash (Min=0, Mean=9, Max=25) n=3.

次要结局

未报告次要终点

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Steven Grindel

Professor

Medical College of Wisconsin

研究点 (1)

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