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Carpel Tunnel Syndrome and Physical Therapy Modalities

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ClinicalTrials.gov Identifier: NCT02745652
Recruitment Status : Completed
First Posted : April 20, 2016
Last Update Posted : April 21, 2016
Sponsor:
Information provided by (Responsible Party):
Dr. Dalia Mohamed Kame, Cairo University

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.

Condition or disease Intervention/treatment Phase
Carpal Tunnel Syndrome Device: pulsed electromagnetic field Device: Therapeutic ultrasound Not Applicable

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  (Clinical Trial)
Actual Enrollment : 55 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Pulsed Magnetic Field Versus Ultrasound in Treatment of Postnatal Carpal Tunnel Syndrome: Randomized Control Trial on Female Egyptian Population
Study Start Date : May 2014
Actual Primary Completion Date : January 2015
Actual Study Completion Date : March 2015


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
Device: pulsed electromagnetic field
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 Name: (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
Device: Therapeutic ultrasound
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 Name: US




Primary Outcome Measures :
  1. 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


Secondary Outcome Measures :
  1. 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



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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:

  • 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

Responsible Party: Dr. Dalia Mohamed Kame, Associate Professor of Physical Therapy, Cairo University
ClinicalTrials.gov Identifier: NCT02745652     History of Changes
Other Study ID Numbers: P.T.REC/012/001211
First Posted: April 20, 2016    Key Record Dates
Last Update Posted: April 21, 2016
Last Verified: April 2016
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
Plan Description: publication in a refereed journal

Keywords provided by Dr. Dalia Mohamed Kame, Cairo University:
median nerve
wrist joint
carpal tunnel

Additional relevant MeSH terms:
Nerve Compression Syndromes
Syndrome
Carpal Tunnel Syndrome
Disease
Pathologic Processes
Median Neuropathy
Mononeuropathies
Peripheral Nervous System Diseases
Neuromuscular Diseases
Nervous System Diseases
Cumulative Trauma Disorders
Sprains and Strains
Wounds and Injuries