Myofascial Release on Electrophysiological Measures of Pregnant Women With CTS

NCT03802448 | Completed Phase 4 DMC

• 1 other identifier: P.T.REC/011/001990
• Study Type: interventional
• Target: 30
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Carpal Tunnel Syndrome

Outcome Measures

Primary Outcomes (1)

• change of Median nerve Distal Motor Latency

  , 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

  pretreatment, after 4 weeks of the treatment

Secondary Outcomes (1)

• change of Boston carpal tunnel questionnaire (BCTQ)

  pretreatment, after 4 weeks of the treatment

Study Arms (2)

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

Device: Control group

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).

Combination Product: Study group; Device: Control group

Interventions

Study group COMBINATION_PRODUCT

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).

Study group

Control group DEVICE

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.

Control group; Study group

Eligibility Criteria

• Age: 25 Years - 35 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• Cairo University: lead

MeSH Terms

Conditions

Carpal Tunnel Syndrome

Interventions

Control Groups

Condition Hierarchy (Ancestors)

Median Neuropathy; Mononeuropathies; Peripheral Nervous System Diseases; Neuromuscular Diseases; Nervous System Diseases; Nerve Compression Syndromes; Cumulative Trauma Disorders; Sprains and Strains; Wounds and Injuries

Intervention Hierarchy (Ancestors)

Epidemiologic Research Design; Epidemiologic Methods; Investigative Techniques; Research Design; Methods

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Deputy Director of Quality Assurance Unit

Study Record Dates

• First Submitted: January 10, 2019
• First Posted: January 14, 2019
• Study Start: May 1, 2013
• Primary Completion: May 1, 2013
• Study Completion: April 1, 2014
• Last Updated: January 14, 2019

Record last verified: 2013-05