Carpel Tunnel Syndrome and Physical Therapy Modalities

April 20, 2016 updated by: Dr. Dalia Mohamed Kame, Cairo University

Pulsed Magnetic Field Versus Ultrasound in Treatment of Postnatal Carpal Tunnel Syndrome: Randomized Control Trial on Female Egyptian Population

Carpel tunnel syndrome (CTS) is very common complain during pregnancy with high percentage to continue postnatal. Conservative treatment is more recommended in these cases. There are many physical therapy modalities proposed to treat CTS without knowing which modality is better than the other. So the aim of this study to compare the effect of two modalities in treating CTS in postnatal females.

Study Overview

Detailed Description

Carpal tunnel syndrome (CTS) is one of the most common peripheral nerve entrapment disorders in the upper limb. CTS is common during pregnancy especially in the third trimester as well, a significant percentage of females postnatal may still have some complaints up to at least 3 years postnatal.

Purpose: To compare the effect of pulsed magnetic field (PEMF) versus ultrasound (US) in treating patients with CTS. Forty postnatal female patients with idiopathic CTS were assigned randomly into two equal groups. One group received PEMF with nerve and tendon gliding exercises for the wrist 3 times for week for 4 weeks. The other group received US plus the same exercises. Pain level, sensory and motor distal latencies of the median nerve (MSDL and MMDL), sensory and motor conduction velocities of the median nerve (MSCV and MMCV), functional status scale and hand grip strength were assessed pre and post treatment

Study Type

Interventional

Enrollment (Actual)

55

Phase

  • Not Applicable

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

25 years to 35 years (Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

Description

Inclusion Criteria:

  • Mild to moderate CTS
  • Positive electro diagnostic findings: prolonged median motor distal latency (MMDL) above 4 ms, and below 6ms.
  • Prolonged median sensory distal latency above 3.5 ms .
  • Positive Phalen and Tinel test.
  • Subjects scored pain intensity more than 5 in visual analogue scale (VAS).

Exclusion Criteria:

  • severe cases with delayed motor distal latency > 6ms.
  • Orthopedic or neurological disorders of neck or the upper limb as cervical radiculopathy.
  • Pronator teres syndrome or double crush syndrome.
  • Pre- existing CTS before their last pregnancy, current pregnancy.
  • Diabetic neuropathy and Thoracic outlet syndrome.
  • Wasting of thenar muscles, ulnar neuropathy.
  • Rheumatoid arthritis, previous fractured carpal bone and previous surgery in the forearm especially transverse ligament release

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: pulsed electromagnetic field (PEMF)
patients in this group received the pulse electromagnetic field with frequency 50 Hz and intensity 80 gauss for 30 min.The patient was in sitting position, while the forearm was rested on the bed inside the solenoid in supination position
it is a magnetic device for magneto-therapy, it has an appliance, motorized bed, and applicable large solenoids which can be moved in 4 different positions according to the treatment area, and the additional small solenoid for hand treatment with 30 cm diameter
Other Names:
  • (PEMF)
Experimental: Therapeutic ultrasound (US)
Pulsed mode US was applied over the volar surface of the forearm (the carpal tunnel area) 15 min per session with a frequency of 1 MHz and intensity of 1.0 W/cm2
Ultrasound is applied using a transducer or applicator that is in direct contact with the patient's skin. Gel is a medium which is used on all surfaces of the head to reduce friction and assist transmission of the ultrasonic waves
Other Names:
  • US

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Pain intensity
Time Frame: 4 weeks change from the baseline scores
it measured by the Visual Analogue Scale (VAS).It is considered a valid way of assessing pain
4 weeks change from the baseline scores

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Functional status scale
Time Frame: 4 weeks change from the baseline scores
It is a part of the Carpal Tunnel Syndrome Questionnaire (CTSQ). it asks about eight functional activities as writing, buttoning of clothes, gripping of a telephone handle
4 weeks change from the baseline scores

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

May 1, 2014

Primary Completion (Actual)

January 1, 2015

Study Completion (Actual)

March 1, 2015

Study Registration Dates

First Submitted

April 14, 2016

First Submitted That Met QC Criteria

April 19, 2016

First Posted (Estimate)

April 20, 2016

Study Record Updates

Last Update Posted (Estimate)

April 21, 2016

Last Update Submitted That Met QC Criteria

April 20, 2016

Last Verified

April 1, 2016

More Information

Terms related to this study

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

Yes

IPD Plan Description

publication in a refereed journal

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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