Carpel Tunnel Syndrome and Physical Therapy Modalities

Carpal Tunnel Syndrome Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02745652
• Other study ID #: P.T.REC/012/001211
• Status: Completed
• Phase: N/A
• First received: April 14, 2016
• Last updated: April 20, 2016
• Start date: May 2014
• Est. completion date: March 2015

Study information

• Verified date: April 2016
• Source: Cairo University
• Contact: n/a
• Is FDA regulated: No
• Health authority: Egypt: Ministry of Higher Education
• Study type: Interventional

Clinical Trial 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.

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 55
• Est. completion date: March 2015
• Est. primary completion date: January 2015
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 25 Years to 35 Years

Eligibility

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 Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Carpal Tunnel Syndrome
• Syndrome

Intervention

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
• 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

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Cairo University

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Yes
Secondary	Functional status scale	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	Yes