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Myofascial Release on Electrophysiological Measures of Pregnant Women With CTS

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ClinicalTrials.gov Identifier: NCT03802448
Recruitment Status : Completed
First Posted : January 14, 2019
Last Update Posted : January 14, 2019
Sponsor:
Information provided by (Responsible Party):
HAhmed, Cairo University

Brief Summary:

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.


Condition or disease Intervention/treatment Phase
Carpal Tunnel Syndrome Combination Product: Study group Device: Control group Phase 4

  Show Detailed Description

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 30 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Participant)
Primary Purpose: Treatment
Official Title: Effect of Myofascial Release on Electrophysiological and Clinical Measures of Pregnant Women With Carpal Tunnel Syndrome
Actual Study Start Date : May 2013
Actual Primary Completion Date : May 2013
Actual Study Completion Date : April 2014


Arm Intervention/treatment
Active Comparator: Control group

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

Device: Control group
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.

Experimental: Study group

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).

Combination Product: Study group

Each pregnant woman in the study group received myofascial release technique, 3 sessions/week for 4 weeks. 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).


Device: Control group
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.




Primary Outcome Measures :
  1. change of Median nerve Distal Motor Latency [ Time Frame: 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


Secondary Outcome Measures :
  1. change of Boston carpal tunnel questionnaire (BCTQ) [ Time Frame: pretreatment, after 4 weeks of the treatment ]
    The questionnaire compromised two scales, a symptoms severity scale (SSS) and a functional status scale (FSS)



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Ages Eligible for Study:   25 Years to 35 Years   (Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • 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.

Exclusion Criteria:

  • 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

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Responsible Party: HAhmed, Deputy Director of Quality Assurance Unit, Cairo University
ClinicalTrials.gov Identifier: NCT03802448     History of Changes
Other Study ID Numbers: P.T.REC/011/001990
First Posted: January 14, 2019    Key Record Dates
Last Update Posted: January 14, 2019
Last Verified: May 2013
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Carpal Tunnel Syndrome
Syndrome
Disease
Pathologic Processes
Median Neuropathy
Mononeuropathies
Peripheral Nervous System Diseases
Neuromuscular Diseases
Nervous System Diseases
Nerve Compression Syndromes
Cumulative Trauma Disorders
Sprains and Strains
Wounds and Injuries