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经皮电神经刺激治疗腕管综合征的疗效:一项随机双盲对照试验。

Effectiveness of Phonophoresis Treatment in Carpal Tunnel Syndrome: A Randomized Double-blind, Controlled Trial.

机构信息

Department of Rehabilitation Medicine, Faculty of Medicine, Chulalongkorn University, Bangkok, Thailand.

出版信息

PM R. 2020 Jan;12(1):8-15. doi: 10.1002/pmrj.12171. Epub 2019 Jun 6.

DOI:10.1002/pmrj.12171
PMID:31006972
Abstract

OBJECTIVE

To determine the effects of phonophoresis of piroxicam (PH-P) and phonophoresis of dexamethasone sodium phosphate (PH-Dex) on mild to moderate carpal tunnel syndrome (CTS), and to compare each of them with the control group of nondrug ultrasound (US) therapy.

DESIGN

A randomized, double-blind controlled trial.

SETTING

Department of rehabilitation medicine, university hospital.

PARTICIPANTS

Patients with clinical signs and symptoms of CTS underwent an electrophysiological study to confirm the diagnosis of CTS and severity grading. Thirty-three patients, 50 hands (52% of the patients had bilateral CTS, n = 17) with mild to moderate CTS were randomly allocated into three study groups: PH-P, PH-Dex, or US.

INTERVENTION

All three groups received 10 sessions of 1-MHz frequency, 1.0 w/cm intensity ultrasound wave with stroking technique, continuous mode, at the palm side of the hand over the carpal tunnel area-10 minutes per session, two to three times per week for 4 weeks, for a total of 10 sessions. During each session, the patients received 15 cm of study gel according to the study groups. The PH-P group received 0.5% piroxicam gel mixture (equivalence of 20 mg of piroxicam). The PH-Dex group received 0.4% dexamethasone sodium phosphate gel mixture (equivalence 60 mg of dexamethasone). The US group received nondrug gel.

MAIN OUTCOME MEASUREMENTS

Boston Carpal Tunnel Questionnaire for symptom severity (BCTQ SYMPT), Boston Carpal Tunnel Questionnaire for functional status (BCTQ FUNCT) and electrophysiological parameters of the median nerve including distal sensory latency (DSL) and distal motor latency (DML) were evaluated before the first treatment and after the last treatment.

RESULTS

After treatment, all treatment groups (PH-P, PH-Dex, and US) showed significant improvements of the BCTQ SYMPT (P < .001, -0.74 ± 0.73 [-1.12, -0.37], -0.91 ± 0.96 [-1.41, -0.42], and - 0.68 ± 0.71 [-1.05, -0.30], respectively) and the BCTQ FUNCT (P < .001, -0.68 ± 0.89 [-1.14, -0.22], -0.74 ± 0.84 [-1.17, -0.30], and - 0.80 ± 0.80 [-1.22, -0.37], respectively). For the BCTQ SYMPT, only the PH-Dex showed an improvement score above MCID at 0.8 level [-0.91 ± 0.96]. The improvement of BCTQ FUNCT score of all groups was above Minimal Clincally Important Difference (MCID) at 0.5 level (-0.68 ± 0.89, -0.74 ± 0.84 and - 0.80 ± 0.80, respectively).The DSL was decreased in all groups but the changes were not statistically significant (P = .70, -0.11 ± 0.34 [-0.28, 0.06], -0.09 ± 0.32 [-0.26, 0.07], and - 0.14 ± 0.29 [-0.29, 0.02], respectively). The DML showed decrease only in PH-DEX and the US group but it was not statistically significant (P = .68, 0.05 ± 0.44 [-0.17, 0.27], -0.09 ± 0.51[-0.34, 0.17], and - 0.27 ± 0.49 [-0.53, 0.01], respectively). All measured outcomes were not statistically different in between-group-comparison of BCTQ SYMPT, BCTQ FUNCT, DSL, and DML (P = .58, P = .79, P = .20 and P = .39, respectively). However, there was a clinically significant difference of the improvement of BCTQ SYMPT in between-group comparison; only the PH-DEX was above the MCID level, while the PH-P and US were not.

CONCLUSIONS

Neither nondrug US nor phonophoresis treatments (PH-P and PH-Dex) were effective to improve the DSL and DML in mild to moderate CTS. All three groups showed significant improvements in clinical symptoms (BCTQ SYMPT) and functional status (BCTQ FUNCT). At 1 MHz frequency and 1.0 w/cm intensity of ultrasound wave, there is no statistically significant difference between phonophoresis and the nondrug US.

LEVEL OF EVIDENCE

I.

摘要

目的

确定吡罗昔康声透(PH-P)和磷酸地塞米松声透(PH-Dex)对轻中度腕管综合征(CTS)的疗效,并将每种治疗方法与非药物超声(US)治疗的对照组进行比较。

设计

随机、双盲对照试验。

地点

大学医院康复医学科。

参与者

具有 CTS 临床症状和体征的患者接受电生理研究以确认 CTS 的诊断和严重程度分级。33 名患者,50 只手(52%的患者有双侧 CTS,n=17),轻度至中度 CTS 患者被随机分配到三个研究组:PH-P、PH-Dex 或 US。

干预措施

三组均接受 1MHz 频率、1.0w/cm 强度超声,采用滑指法,连续模式,在手部腕管区域的手掌侧进行治疗,每次 10 分钟,每周 2-3 次,共 10 次。每次治疗时,患者根据研究组接受 15cm 的研究凝胶。PH-P 组接受 0.5%吡罗昔康凝胶混合物(相当于 20mg 吡罗昔康)。PH-Dex 组接受 0.4%磷酸地塞米松钠凝胶混合物(相当于 60mg 地塞米松)。US 组接受非药物凝胶。

主要观察指标

Boston 腕管综合征问卷症状严重程度(BCTQ SYMPT)、Boston 腕管综合征问卷功能状态(BCTQ FUNCT)以及正中神经的电生理参数,包括远端感觉潜伏期(DSL)和远端运动潜伏期(DML),在首次治疗前和最后一次治疗后进行评估。

结果

治疗后,所有治疗组(PH-P、PH-Dex 和 US)的 BCTQ SYMPT(P<.001,-0.74±0.73[-1.12,-0.37],-0.91±0.96[-1.41,-0.42]和-0.68±0.71[-1.05,-0.30])和 BCTQ FUNCT(P<.001,-0.68±0.89[-1.14,-0.22],-0.74±0.84[-1.17,-0.30]和-0.80±0.80[-1.22,-0.37])均有显著改善。对于 BCTQ SYMPT,只有 PH-Dex 在 0.8 水平上的改善评分达到 MCID(-0.91±0.96)。所有组的 BCTQ FUNCT 评分改善均达到 MCID(-0.68±0.89,-0.74±0.84 和-0.80±0.80)。各组的 DSL 均有所下降,但无统计学意义(P=0.70,-0.11±0.34[-0.28,0.06],-0.09±0.32[-0.26,0.07]和-0.14±0.29[-0.29,0.02])。DML 仅在 PH-DEX 和 US 组中下降,但无统计学意义(P=0.68,0.05±0.44[-0.17,0.27],-0.09±0.51[-0.34,0.17]和-0.27±0.49[-0.53,0.01])。组间比较 BCTQ SYMPT、BCTQ FUNCT、DSL 和 DML 差异均无统计学意义(P=0.58、P=0.79、P=0.20 和 P=0.39)。然而,在 BCTQ SYMPT 的组间比较中,改善程度存在临床显著差异;只有 PH-Dex 达到了 MCID 水平,而 PH-P 和 US 则没有。

结论

非药物 US 治疗或声透治疗(PH-P 和 PH-Dex)均不能改善轻度至中度 CTS 的 DSL 和 DML。三组患者的临床症状(BCTQ SYMPT)和功能状态(BCTQ FUNCT)均有显著改善。在 1MHz 频率和 1.0w/cm 强度的超声下,声透与非药物 US 之间无统计学显著差异。

证据水平

I。

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