Pan African Clinical Trials Registry
South African Medical Research Council, South African Cochrane Centre
PO Box 19070, Tygerberg, 7505, South Africa
Telephone: +27 21 938 0506 / +27 21 938 0834 Fax: +27 21 938 0836
Email: pactradmin@mrc.ac.za Website: pactr.samrc.ac.za
Trial no.: PACTR201703001820218 Date of Approval: 13/10/2016
Trial Status: Retrospective registration - This trial was registered after enrolment of the first participant
TRIAL DESCRIPTION
Public title Contralateral vs Ipsilateral Neural Mobilization of Median Nerve in P atients with Unilateral Carpal Tunnel Syndrome
Official scientific title Contralateral vs Ipsilateral Neural Mobilization of Median Nerve in P atients with Unilateral Carpal Tunnel Syndrome
Brief summary describing the background and objectives of the trial 1-objectively measure the effect of contralaterl neural mobilization on the ipsilateral hand with CTS 2-objectively measure the effect of neural mobilization on the ipsilateral hand with CTS Specific 3- Compare the effects of the two sides together .
Type of trial RCT
Acronym (If the trial has an acronym then please provide)
Disease(s) or condition(s) being studied carpal tunel syndrome
Sub-Disease(s) or condition(s) being studied
Purpose of the trial Treatment: Other
Anticipated trial start date 01/06/2015
Actual trial start date 01/06/2015
Anticipated date of last follow up 30/10/2016
Actual Last follow-up date 31/01/2017
Anticipated target sample size (number of participants) 45
Actual target sample size (number of participants)
Recruitment status Recruiting
Publication URL
Secondary Ids Issuing authority/Trial register
STUDY DESIGN
Intervention assignment Allocation to intervention If randomised, describe how the allocation sequence was generated Describe how the allocation sequence/code was concealed from the person allocating the participants to the intervention arms Masking If masking / blinding was used
Parallel: different groups receive different interventions at same time during study Randomised male and female are choosen blindly with just suuffering from CTS Numbered containers Open-label(Masking Not Used)
INTERVENTIONS
Intervention type Intervention name Dose Duration Intervention description Group size Nature of control
Experimental Group Therapeutic exercise (ipsilateral neural mobilization) + ¿ 10 minutes exercise in each session + 30 minutes electrotherapy 2 weeks Therapeutic exercise in the form of ipsilateral neural mobilization to the median nerve + 15
Experimental Group Therapeutic exercise (contralateral neural mobilization) + electrotherapy ¿ 10 minutes exercise in each session + 30 minutes electrotherapy 2 weeks Therapeutic exercise in the form of contralateral neural mobilization to the median nerve + 15
Control Group electrotherapy ¿ 30 minutes electrotherapy in each session 2 weeks Electrotherapy In the form of therapeutic ultrasonic pulses, transcutaneous electric nerve stimulation (TENS) and infrared waves at the wrist region. 15 Active-Treatment of Control Group
ELIGIBILITY CRITERIA
List inclusion criteria List exclusion criteria Age Category Minimum age Maximum age Gender
¿ Age from 30-45. ¿ Unilateral CTS. ¿ All patients should have positive electro diagnosis findings. ¿ Mild and moderate cases only Patients suffering from any orthopedic or neurogenic disorder of the neck or the upper limb as cervical radiculopathy , pronator teres syndrome and double crush syndrome ¿ Pregnant women. ¿ Any patient that has function impairment will be excluded. 30 Year(s) 50 Year(s) Both
ETHICS APPROVAL
Has the study received appropriate ethics committee approval Date the study will be submitted for approval Date of approval Name of the ethics committee
Yes 28/05/2015 physical therapy faculty committe
Ethics Committee Address
Street address City Postal code Country
faculty of physical therapy cairo university cairo 12624 Egypt
OUTCOMES
Type of outcome Outcome Timepoint(s) at which outcome measured
Primary Outcome comparing the effect of contralateral neural moblization on ipsilateral carpal tunnel syndrome with ipsilateral neuralmbblization on ipsilateral carpal tunnel syndrome comparing the effect of contralateral neural moblization on ipsilateral carpal tunnel syndrome with ipsilateral neuralmbblization on ipsilateral carpal tunnel syndrome after 2 weeks
Primary Outcome objectively evaluating the effect of both contralateral neural moblization and ipsilateral neuralmbblization on ipsilateral on ipsilateral carpal tunnel syndrome 2 weeks of applying the ipsilateral neural mobilization and 2 weeks applying the contralateral neural mobilization
RECRUITMENT CENTRES
Name of recruitment centre Street address City Postal code Country
elhadral universal hospital suez canal street alexandria 21516 Egypt
FUNDING SOURCES
Name of source Street address City Postal code Country
cairo university cairo unveersity G iza cairo 12624 Egypt
cairo university cairo unveersity G iza cairo 12624 Egypt
SPONSORS
Sponsor level Name Street address City Postal code Country Nature of sponsor
Primary Sponsor cairo university cairo unveersity G iza cairo 12624 Egypt University
COLLABORATORS
Name Street address City Postal code Country
mohamed elgendy ,olfet cairo unveersity G iza cairo 12624 Egypt
CONTACT PEOPLE
Role Name Email Phone Street address
Principal Investigator mahmoud sabry asal mahmoudassal@gmail.com 00201065738393 60 Rostm basha street ,Vectoria
City Postal code Country Position/Affiliation
Alexandria 33624 Egypt Assistant lecturer, faculty of physiotherapy, South Valley university.
Role Name Email Phone Street address
Public Enquiries Amir Mohamed Saleh amirsalehed@hotmail.com 00201006158873 South Valley University street
City Postal code Country Position/Affiliation
Qena 83523 Egypt Dean of faculty of physiotherapy, South Valley university
Role Name Email Phone Street address
Scientific Enquiries Olfat Ibrahim Ali Olfat_ib@yahoo.com 00201001248426 7 Ahmed Elzayat street, Dokki
City Postal code Country Position/Affiliation
Giza 12613 Egypt Lecturer of physical therapy ,faculty of physiotherapy, Cairo university
REPORTING
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