富血小板血浆与皮质类固醇注射治疗扳机指：前瞻性随机三盲安慰剂对照试验研究方案。
Platelet-rich plasma versus corticosteroid injection for treatment of trigger finger: study protocol for a prospective randomized triple-blind placebo-controlled trial.
机构信息
Department of Hand Surgery, Helsinki University Hospital, Topeliuksenkatu 5, 00260, Helsinki, Finland.
Department of Orthopaedics and Traumatology, Kanta-Häme Central Hospital, Ahvenistontie 20, 13530, Hämeenlinna, Finland.
出版信息
Trials. 2020 Nov 27;21(1):984. doi: 10.1186/s13063-020-04907-w.
BACKGROUND
Trigger finger is a common hand disorder that limits finger range of motion and causes pain and snapping of the affected finger. Trigger finger is caused by an imbalance of the tendon sheath and the flexor tendon. The initial treatment is generally a local corticosteroid injection around the first annular (A1) pulley. However, it is not unusual that surgical release of the A1 pulley is required. Moreover, adverse events after local corticosteroid injection or operative treatment may occur. Platelet-rich plasma (PRP) has been shown to be safe and to reduce symptoms in different tendon pathologies, such as DeQuervain's disease. However, the effects of PRP on trigger finger have not been studied. The aim of this single-center triple-blind randomized controlled trial is to study whether PRP is non-inferior to corticosteroid injection in treating trigger finger. The secondary outcome is to assess the safety and efficacy of PRP in comparison to placebo.
METHODS
The trial is designed as a randomized, controlled, patient-, investigator-, and outcome assessor-blinded, single-center, three-armed 1:1:1 non-inferiority trial. The patients with clinical symptoms of trigger finger will be randomly assigned to treatment with PRP, corticosteroid, or normal saline injection. The primary outcome is Patient-Rated Wrist Evaluation and symptom resolution. Secondary outcomes include Quick-Disabilities of the Arm, Shoulder and Hand; pain; grip strength; finger active range of motion; and complications. Appropriate statistical methods will be applied.
DISCUSSION
We present a novel RCT study design on the use of PRP for the treatment of trigger finger compared to corticosteroid and normal saline injection. The results of the trial will indicate if PRP is appropriate for the treatment of trigger finger.
TRIAL REGISTRATION
ClinicalTrials.gov NCT04167098 . Registered on November 18, 2019.
背景
扳机指是一种常见的手部疾病，会限制手指的活动范围，并导致受影响的手指疼痛和弹响。扳机指是由屈肌腱鞘和屈肌腱之间的不平衡引起的。最初的治疗方法通常是在第一环状（A1）滑车周围进行局部皮质类固醇注射。然而，通常需要手术松解 A1 滑车。此外，局部皮质类固醇注射或手术治疗后可能会出现不良反应事件。富血小板血浆（PRP）已被证明在不同的肌腱病变中是安全的，可以减轻症状，例如德奎文氏病。然而，PRP 对扳机指的影响尚未得到研究。本单中心、三盲、随机对照临床试验旨在研究 PRP 在治疗扳机指方面是否不劣于皮质类固醇注射。次要结局是评估 PRP 与安慰剂相比的安全性和疗效。
方法
该试验设计为随机、对照、患者、研究者和结果评估者双盲、单中心、三臂 1:1:1 非劣效性试验。具有扳机指临床症状的患者将被随机分配接受 PRP、皮质类固醇或生理盐水注射治疗。主要结局是患者手腕评估和症状缓解。次要结局包括快速上肢、肩部和手功能障碍问卷、疼痛、握力、手指主动活动范围和并发症。将应用适当的统计方法。
讨论
我们提出了一种新的 RCT 研究设计，比较了 PRP 治疗扳机指与皮质类固醇和生理盐水注射的效果。该试验的结果将表明 PRP 是否适合治疗扳机指。
试验注册
ClinicalTrials.gov NCT04167098。于 2019 年 11 月 18 日注册。
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