- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02745652
Carpel Tunnel Syndrome and Physical Therapy Modalities
Pulsed Magnetic Field Versus Ultrasound in Treatment of Postnatal Carpal Tunnel Syndrome: Randomized Control Trial on Female Egyptian Population
Study Overview
Status
Conditions
Intervention / Treatment
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
Enrollment (Actual)
Phase
- Not Applicable
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
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
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:
|
|
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:
|
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
Sponsor
Study record dates
Study Major Dates
Study Start
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Estimate)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- P.T.REC/012/001211
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
IPD Plan Description
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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