Comparison of Ultrasound-Guided Betamethasone and Dextrose Injections in the Treatment of Trigger Finger: A Randomized Controlled Trial
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 42
- 试验地点
- 2
- 主要终点
- Change in pain intensity assessed by Numeric Rating Scale (NRS)
研究概览
简要总结
This study aims to compare the effectiveness of ultrasound-guided betamethasone and dextrose injections in patients with trigger finger.
Trigger finger is a common hand condition characterized by pain, clicking, and locking of the finger due to tendon entrapment at the A1 pulley. Corticosteroid injections are widely used as a first-line treatment; however, they may be associated with potential side effects.
Dextrose injection is an alternative treatment that may promote tissue healing through regenerative mechanisms. However, there is limited high-quality evidence regarding its effectiveness in trigger finger.
In this randomized controlled trial, patients will be assigned to receive either betamethasone or dextrose injection under ultrasound guidance. The primary outcome will be pain intensity measured by the Numeric Rating Scale (NRS). Secondary outcomes will include triggering severity, hand function, grip and pinch strength, and fine motor skills evaluated over a 12-week follow-up period.
The results of this study may help determine whether dextrose injection is a safe and effective alternative to corticosteroid treatment in trigger finger.
详细描述
Trigger finger, also known as stenosing tenosynovitis, is a common hand disorder characterized by pain, catching, and locking of the affected digit due to impaired gliding of the flexor tendon at the A1 pulley. It can significantly impair hand function and quality of life.
Corticosteroid injections are widely accepted as an effective first-line treatment for trigger finger. However, potential adverse effects such as skin atrophy, tendon rupture, and systemic effects, particularly in patients with metabolic disorders, have led to increasing interest in alternative treatment options.
Dextrose injection has emerged as a potential alternative treatment modality in musculoskeletal disorders. However, there is limited high-quality evidence evaluating its effectiveness in trigger finger.
The aim of this prospective, randomized controlled trial is to compare the clinical effectiveness of ultrasound-guided betamethasone injection and dextrose injection in patients with trigger finger.
Eligible participants aged 18 to 75 years with clinically diagnosed trigger finger of at least 4 weeks' duration will be enrolled. Patients will be randomly assigned to one of two groups. One group will receive an ultrasound-guided injection of 1 ml lidocaine and 1 ml betamethasone, while the other group will receive an ultrasound-guided injection of 1 ml lidocaine and 1 ml 30% dextrose solution (resulting in a final concentration of 15% dextrose). All injections will be performed under sterile conditions at the A1 pulley level.
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
- Triple (Participant, Investigator, Outcomes Assessor)
盲法说明
Participants, the injector investigator, and the outcome assessor will be blinded to treatment allocation. Injections will be prepared by an independent researcher using opaque-covered syringes so that the injector investigator will not be aware of the injected solution. Randomization will be performed by an independent researcher who will not participate in outcome assessment.
入排标准
- 年龄范围
- 18 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age between 18 and 75 years
- •Clinical diagnosis of trigger finger
- •Presence of symptoms for at least 4 weeks
排除标准
- •Previous surgery on the affected finger
- •Injection treatment to the affected finger within the previous 3 months
- •Active local or systemic infection
- •Active malignancy
- •Active inflammatory rheumatic disease (e.g., rheumatoid arthritis, ankylosing spondylitis, polymyalgia rheumatica, vasculitis)
- •Uncontrolled diabetes mellitus and/or uncontrolled hypertension
- •Autoimmune connective tissue diseases (e.g., systemic lupus erythematosus, antiphospholipid syndrome, systemic sclerosis, Sjögren syndrome, polymyositis, dermatomyositis, adult-onset Still's disease)
- •Coagulopathy that increases the risk of injection procedures
- •Pregnancy
- •Known allergy or hypersensitivity to lidocaine, betamethasone, or dextrose
- •Mental impairment or severe psychiatric disorder that may interfere with study participation or informed consent
研究组 & 干预措施
Betamethasone Injection
Participants in this arm will receive an ultrasound-guided injection of 1 ml lidocaine combined with 1 ml betamethasone at the A1 pulley level for the treatment of trigger finger.
干预措施: Betamethasone (Drug)
Dextrose Injection
Participants in this arm will receive an ultrasound-guided injection of 1 ml lidocaine combined with 1 ml 30% dextrose solution (final concentration 15%) at the A1 pulley level for the treatment of trigger finger.
干预措施: Dextrose Injection (Other)
结局指标
主要结局
Change in pain intensity assessed by Numeric Rating Scale (NRS)
时间窗: Baseline, 1 hour, 2 weeks, 4 weeks, and 12 weeks
Pain intensity will be evaluated using the 11-point Numeric Rating Scale (NRS), where 0 indicates no pain and 10 indicates worst imaginable pain.
次要结局
- Change in triggering severity assessed by Modified Quinnell classification(Baseline, 2 weeks, 4 weeks, and 12 weeks)
- Change in hand function assessed by QuickDASH(Baseline, 2 weeks, 4 weeks, and 12 weeks)
- Change in grip strength(Baseline, 2 weeks, 4 weeks, and 12 weeks)
- Change in pinch strength(Baseline, 2 weeks, 4 weeks, and 12 weeks)
- Change in fine motor skills assessed by Purdue Pegboard test(Baseline, 4 weeks, and 12 weeks)
研究者
Merve Yıldız
Principal Investigator
Istanbul University - Cerrahpasa