Differential Efficacy of Corticosteroid Solutions for Non-Operative Treatment of Digit Flexor Tenosynovitis: A Double-Blind Prospective Randomized Clinical Trial
试验速览
- 阶段
- 4 期
- 状态
- 终止
- 入组人数
- 95
- 试验地点
- 1
- 主要终点
- Disabilities of the Arm, Shoulder and Hand (DASH)
研究概览
简要总结
Trigger finger is a common cause of hand pain and dysfunction. Its due to chronic inflammation of the flexor tendon that leads to a pulley system mismatch. Historically it has been managed either conservatively with corticosteroid injections or through a surgical release of the A1 pulley. Several corticosteroids have been used for injection- dexamethasone, methylprednisolone, triamcinolone, betamethasone, paramethasone, etc. The purpose of out study is to determine if a 0.5 cc injection of Triamcinolone 40 mg/mL will be the most effective steroid injection for the non-surgical treatment. Approximately 200 subjects will be enrolled and randomized to one of three treatment arms: Triamcinolone 40mg/mL, Triamcinolone 10mg/mL and Soluble dexamethasone 4mg/mL. Treatment success will be defined as lack of conversion to surgical treatment, or no desire to proceed with surgery during study period (3 months).
详细描述
Idiopathic stenosing tenosynovitis of the digits, more commonly known as "trigger finger", is a common cause of hand pain and dysfunction. Many previous studies have described the pathophysiology of this condition and it can be summarized as inflammation of the flexor tendons leading to a size mismatch between the tendon and the flexor pulley system. By far the most common location of this mismatch is at the A1 pulley.
The current mainstay of treatment has been:
- Injection of corticosteroid into the area immediately surrounding the A1 pulley and flexor tendon
- Surgical release of the A1 pulley
Several corticosteroids have been used for injection- dexamethasone, methylprednisolone, triamcinolone, betamethasone, paramethasone, etc. Less commonly used treatment strategies have included: topical NSAIDs and extracorporeal shock therapy. The typical progression of treatment is one or two steroid injections and then surgical release if injections have failed.
To our knowledge, there have been no head to head comparison studies of the efficacy of different corticosteroid formulations in preventing conversion to surgical treatment. In our study, the investigators will look at the efficacy of two of the most commonly used steroids: triamcinolone and dexamethasone.
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
- •Adults aged 18 years and older
- •At least one symptomatic trigger finger
- •Patients recommended to receive corticosteroid injections
排除标准
- •Previous surgeries/injections for trigger fingers in digit being treated for study
- •Participating in another clinical trial
- •Inability to receive corticosteroid injections (i.e. allergies, adverse reactions, etc.)
- •Unable to sign informed consent
- •Pregnant or plan to become pregnant
研究组 & 干预措施
Triamcinolone 40mg/mL
A corticosteroid injection of Triamcinolone 40mg/mL will be given to subjects to treat their symptoms of trigger finger.
干预措施: Triamcinolone Acetonide 40mg/mL (Drug)
Triamcinolone 10mg/mL
A corticosteroid injection of Triamcinolone 10mg/mL will be given to subjects to treat their symptoms of trigger finger.
干预措施: Triamcinolone Acetonide 10mg/mL (Drug)
Soluble dexamethasone 4mg/mL
A corticosteroid injection of Soluble Dexamethasone 4mg/mL will be given to subjects to treat their symptoms of trigger finger.
干预措施: Dexamethasone 4 mg/ml (Drug)
结局指标
主要结局
Disabilities of the Arm, Shoulder and Hand (DASH)
时间窗: 6 Month
The patient will be asked to complete a questionnaire with questions related to their hand. Their answers will be scored on a scale of 0-100 with 0 being no disability and 100 being the highest level of disability.
Pain Visual Analog Score (VAS)
时间窗: 6 Month
The patient will be asked to report their pain on a scale of 0 - 10 using the Visual Analog Scale with 0 being no pain and 10 being the worst pain the patient can imagine.
Patient Reported Outcomes Measurement Information System (PROMIS) Upper Extremity Scores
时间窗: 6 Month
PROMIS Physical Function - Upper Extremity is a self-reported performance measure assessing physical function of the upper extremity focusing on nine activities that require use of the upper extremity including shoulder, arm, and hand activities. Responses are as follows: 5 = Without any difficulty; 4 = With a little difficulty; 3=With some difficulty; 2=With much difficulty; and 1=Unable to do. The PROMIS Upper Extremity assessment evaluates upper extremity function, with raw scores typically ranging from 8 to 40, depending on the specific form used. These raw scores are converted to T-scores using a standardized table, with a mean of 50 and a standard deviation of 10. These T-scores range from 15 to 61. A higher T-score indicates better upper extremity function, while a lower T-score signifies greater impairment.
次要结局
未报告次要终点
研究者
Daniel London
Assistant Professor, Orthopaedic Surgery
University of Missouri-Columbia