NCT02745652

Brief Summary

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.

Trial Health

100
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
55

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started May 2014

Shorter than P25 for not_applicable

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

May 1, 2014

Completed
8 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2015

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2015

Completed
1.1 years until next milestone

First Submitted

Initial submission to the registry

April 14, 2016

Completed
6 days until next milestone

First Posted

Study publicly available on registry

April 20, 2016

Completed
Last Updated

April 21, 2016

Status Verified

April 1, 2016

Enrollment Period

8 months

First QC Date

April 14, 2016

Last Update Submit

April 20, 2016

Conditions

Keywords

median nervewrist jointcarpal tunnel

Outcome Measures

Primary Outcomes (1)

  • Pain intensity

    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 Outcomes (1)

  • Functional status scale

    4 weeks change from the baseline scores

Study Arms (2)

pulsed electromagnetic field (PEMF)

EXPERIMENTAL

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

Device: pulsed electromagnetic field

Therapeutic ultrasound (US)

EXPERIMENTAL

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

Device: Therapeutic ultrasound

Interventions

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

Also known as: (PEMF)
pulsed electromagnetic field (PEMF)

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

Also known as: US
Therapeutic ultrasound (US)

Eligibility Criteria

Age25 Years - 35 Years
Sexfemale
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • 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).

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

Carpal Tunnel SyndromeMedian Neuropathy

Interventions

Ultrasonic Therapy

Condition Hierarchy (Ancestors)

MononeuropathiesPeripheral Nervous System DiseasesNeuromuscular DiseasesNervous System DiseasesNerve Compression SyndromesCumulative Trauma DisordersSprains and StrainsWounds and Injuries

Intervention Hierarchy (Ancestors)

DiathermyHyperthermia, InducedTherapeutics

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Associate Professor of Physical Therapy

Study Record Dates

First Submitted

April 14, 2016

First Posted

April 20, 2016

Study Start

May 1, 2014

Primary Completion

January 1, 2015

Study Completion

March 1, 2015

Last Updated

April 21, 2016

Record last verified: 2016-04

Data Sharing

IPD Sharing
Will share

publication in a refereed journal