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临床试验/NCT03802448
NCT03802448已完成4 期

Effect of Myofascial Release on Electrophysiological and Clinical Measures of Pregnant Women With Carpal Tunnel Syndrome

Cairo University0 个研究点目标入组 30 人开始时间: 2013年5月最近更新:
适应症
干预措施

试验速览

阶段
4 期
状态
已完成
入组人数
30
主要终点
change of Median nerve Distal Motor Latency

研究概览

简要总结

Objective: To explore the effect of myofascial release on electrophysiological and clinical measures of pregnant women with carpal tunnel syndrome (CTS).

Design: Randomized controlled trial. Methods: Thirty pregnant women had CTS, their age ranged from 25-35 years, were randomized into two equal groups. The control group only wore a natural wrist splint during sleeping for 4 weeks, while the study group received a myofascial release in addition to wearing a natural wrist splint during sleeping for 4 weeks. All pregnant women in both groups were evaluated pre and post-treatment through median nerve distal motor latency (DML) and Boston carpal tunnel questionnaire (BCTQ) to assess pain, numbness & tingling sensation severity and hand function.

详细描述

Design This study was designed as a prospective, randomized, controlled trial. The Research Ethical Committee of the Faculty of Physical Therapy, Cairo University approved this study. The study was conducted between May 2013 and April 2014.

Participants A sample of thirty pregnant women were recruited from the Obstetric Out-patient Clinic, El-Sahel Teaching Hospital, Cairo, Egypt. To be included in the study, the participants were chosen pregnant women at early of the third trimester complaining from idiopathic CTS (pain, numbness and tingling of the hand), which was confirmed by electrophysiological examination (i.e. delayed median DML < 3.9 msec) as well as positive Phalen's test. Pregnant women having bilateral and unilateral CTS affection participated but the dominant hand data only were enrolled in this study. Their ages ranged from 25 to 35 years old, their body mass index (BMI) did not exceed 34 Kg/m2 and their gravidity number ranged from 1 to 3 times. The participants were excluded if they had other predisposing causes for CTS and/or neuromuscular diseases that might affect median nerve transmission such as diabetes mellitus, pre-eclampsia, rheumatoid arthritis, previous CTS symptoms, acute hand trauma, cervical spondylosis, previous surgeries in the forearm involving the median nerve, peripheral neuropathy and pronator teres syndrome. All pregnant women did not receive any physical or medical therapy for treating CTS complains and had no serious medical problems as pacemaker and heart diseases that might interfere with electrophysiological testing.

Randomization Informed consent was signed by each participant after explaining the nature, purpose, and benefits of the study, informing them of their right to refuse or withdraw at any time, and about the confidentiality of any obtained data. The pregnant women were randomly assigned into two equal groups (control group and study group), a computer-based randomization program. No dropping out of subjects from the study after randomization.

Interventions Participants were randomly assigned into; Control group composed of fifteen pregnant women who only wore a natural wrist splint during sleeping for 4 weeks. Study group composed of fifteen pregnant women who received a myofascial release in addition to wearing a natural wrist splint during sleeping for 4 weeks.

Neutral wrist splint A neutral wrist splint was worn by all pregnant women in both groups daily at night, only all through the study time (4 weeks). This neutral wrist splint was used to keep the wrist in a straight position (neutral position) and to prevent the extreme wrist motion (flexion and extension) while sleeping.

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
Single (Participant)

入排标准

年龄范围
25 Years 至 35 Years(Adult)
性别
Female
接受健康志愿者

入选标准

  • To be included in the study, the participants were chosen pregnant women at early of the third trimester complaining from idiopathic CTS (pain, numbness and tingling of the hand), which was confirmed by electrophysiological examination (i.e. delayed median DML < 3.9 msec) as well as positive Phalen's test. Pregnant women having bilateral and unilateral CTS affection participated but the dominant hand data only were enrolled in this study. Their ages ranged from 25 to 35 years old, their body mass index (BMI) did not exceed 34 Kg/m2 and their gravidity number ranged from 1 to 3 times.

排除标准

  • The participants were excluded if they had other predisposing causes for CTS and/or neuromuscular diseases that might affect median nerve transmission such as diabetes mellitus, pre-eclampsia, rheumatoid arthritis, previous CTS symptoms, acute hand trauma, cervical spondylosis, previous surgeries in the forearm involving the median nerve, peripheral neuropathy and pronator teres syndrome. All pregnant women did not receive any physical or medical therapy for treating CTS complains and had no serious medical problems as pacemaker and heart diseases that might interfere with electrophysiological testing

研究组 & 干预措施

Control group

Active Comparator

composed of fifteen pregnant women who only wore a natural wrist splint during sleeping for 4 weeks.

A neutral wrist splint was worn by all pregnant women in both groups daily at night, only all through the study time (4 weeks). This neutral wrist splint was used to keep the wrist in a straight position (neutral position) and to prevent the extreme wrist motion (flexion and extension) while sleeping

干预措施: Control group (Device)

Study group

Experimental

a myofascial release in addition to wearing a natural wrist splint during sleeping for 4 weeks.

Myofascial wrist retinaculum (Transverse carpal ligament) release.

• Second part; Interosseous membrane and forearm muscles myofascial release (Bilateral thumb pressure technique).

干预措施: Study group (Combination Product)

Study group

Experimental

a myofascial release in addition to wearing a natural wrist splint during sleeping for 4 weeks.

Myofascial wrist retinaculum (Transverse carpal ligament) release.

• Second part; Interosseous membrane and forearm muscles myofascial release (Bilateral thumb pressure technique).

干预措施: Control group (Device)

结局指标

主要结局

change of Median nerve Distal Motor Latency

时间窗: pretreatment, after 4 weeks of the treatment

, the active recording electrode was placed on the motor point of the abductor pollicis brevis muscle and the reference recording electrode on the tip of the thumb. They were fixed to the hand by adhesive plaster straps. The bipolar stimulating electrode was placed above the wrist joint between the tendons of palmaris longus and the flexor carpi radialis muscles on the course of the median nerve, with the negative pole distal toward the active recording electrode, and the positive pole proximal to stimulate the median nerve. The ground electrode was placed on the distal wrist crease midway between the stimulating and recording electrodes, 7 mA was used at wrist stimulation

次要结局

  • change of Boston carpal tunnel questionnaire (BCTQ)(pretreatment, after 4 weeks of the treatment)

研究者

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

HAhmed

Deputy Director of Quality Assurance Unit

Cairo University

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