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.: PACTR201907468058636 Date of Approval: 24/07/2019
Trial Status: Retrospective registration - This trial was registered after enrolment of the first participant
TRIAL DESCRIPTION
Public title Influence of Microcurrent Electrical Stimulation on Median Nerve Conduction Velocity and Mechanical Pain Threshold: A Randomized Single Blind Controlled Trial
Official scientific title Influence of Microcurrent Electrical Stimulation on Median Nerve Conduction Velocity and Mechanical Pain Threshold: A Randomized Single Blind Controlled Trial
Brief summary describing the background and objectives of the trial Microcurrent electrical stimulation (MES) is a promising modality for a variety of conditions. It is a low level of electrical stimulation that resembles the body’s own natural current. It involves the application of electric currents of the order of millionths of an amp. there was evidence that MES can promote healing in a variety of soft tissues injuries. One of the suggested mechanisms for its therapeutic effects is increased ATP production by the mitochondria at the cellular level. However, the effects of MES on the peripheral nerves remain unclear. Thus, the aim of the present study was to investigate the neurophysiologic effects of MES. Therefore this study may serve as a guide for future studies on the clinical treatment approach concerning peripheral nerve injuries.
Type of trial RCT
Acronym (If the trial has an acronym then please provide)
Disease(s) or condition(s) being studied nerve conduction velocity
Sub-Disease(s) or condition(s) being studied
Purpose of the trial Rehabilitation
Anticipated trial start date 01/02/2016
Actual trial start date 01/02/2016
Anticipated date of last follow up 09/06/2016
Actual Last follow-up date 09/06/2016
Anticipated target sample size (number of participants) 60
Actual target sample size (number of participants)
Recruitment status Completed
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
Factorial: participants randomly allocated to either no, one, some or all interventions simultaneously Randomised Simple randomization using by using procedures such as coin-tossing or dice-rolling Sealed opaque envelopes Masking/blinding used Outcome Assessors
INTERVENTIONS
Intervention type Intervention name Dose Duration Intervention description Group size Nature of control
Experimental Group Microcurrent Electrical stimulation using the frequency of 10 Hz, the intensity of 100 µ A Before application of the MES, the sites of electrodes placement were cleaned by alcohol. Two circular self adhesive electrodes (Skintact electrodes, Austria) were applied to the volar aspect of the forearm; one electrode just above wrist level and the other just below the elbow joint along course of the median nerve. After the electrodes were taped into place, the device was turned on and adjusts frequency of 10 Hz, intensity of 100 µA using Trio-300 (ITO Co., Ltd., Tokyo, Japan)Yoon, et al.,1997). MES was applied for 30 min. immediately after termination of MES application electrophysiological parameter and pain pressure threshold were measured and in addition after 30 min of application. For the control group MES application was the same as the study group except the intensity was not increased (kept on zero). 30 minutes Application of MES for 30 minutes using frequency of 10 Hz, the intensity of 100 µ A to the volar aspect of the non-dominant forearm one electrode above wrist level and the other below the elbow joint along the course of the median nerve using surface electrodes. 30
Control Group Placebo MES No output MES was applied for 30 min. Before application of the MES, the sites of electrodes placement were cleaned by alcohol. Two circular self-adhesive electrodes (Skintact electrodes, Austria) were applied to the volar aspect of the forearm; one electrode just above wrist level and the other just below the elbow joint along the course of the median nerve. After the electrodes were taped into place, the device was turned on and adjusts the frequency of 10 Hz, the intensity of 100 µA using Trio-300 (ITO Co., Ltd., Tokyo, Japan)Yoon, et al.,1997). MES was applied for 30 min. immediately after termination of MES application electrophysiological parameter and pain pressure threshold was measured and in addition after 30 min of application. For the control group, MES application was the same as the study group except the intensity was not increased (kept on zero). 30 Placebo
ELIGIBILITY CRITERIA
List inclusion criteria List exclusion criteria Age Category Minimum age Maximum age Gender
Healthy Smoker Diabetes Previous injury to the upper limbs Adult: 19 Year-44 Year 19 Year(s) 24 Year(s) Male
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 07/04/2015 Research Ethical Committee
Ethics Committee Address
Street address City Postal code Country
7 Ahmed Elzayat Street - Dokki - Giza Giza 11432 Egypt
OUTCOMES
Type of outcome Outcome Timepoint(s) at which outcome measured
Secondary Outcome A pressure algometer (Pain Diagnostics and Treatment Inc, Italy) was used to quantify the pressure pain threshold (PPT The PPT was the amount of pressure in pounds (lb) that each participant immediately perceived as painful, the measurement point was standardized midway between two stimulating electrodes. Once the initial contact was made, the manual force was applied perpendicularly onto the skin through the circular probe head (1 cm2 surface area) of the algometer. The force was increased at a steady rate until the PPT was registered. PPT was determined by the subject’s verbal report when a pain sensation was elicited. As participants were instructed to say "Stop" when the pressure became painful. PPT was measured before MES application and immediately after, and after 30 min of MES application. The mean of three successive measurements was taken for each study time Immediately after and then after 30 minutes
Primary Outcome The study included testing of motor and sensory conduction velocity studies motor nerve conduction velocity (MNCV) and sensory nerve conduction velocity (SNCV). All measurements were done under standard room temperature of 25°C. The participants were informed about the sensation they were going to experience during the EMG measurement. The skin under the stimulating, recording and ground electrodes was cleaned with alcohol to reduce the skin resistance, gel was applied to electrodes for good conduction and electrodes were fixed firmly with adhesive tape Before, Immediately after and 30 minutes after application
RECRUITMENT CENTRES
Name of recruitment centre Street address City Postal code Country
Faculty of Physical Therapy Cairo University 7 Ahmed Elzayat street - Dokki Giza Egypt
FUNDING SOURCES
Name of source Street address City Postal code Country
Salaheldin Bassit Elsayed Olfat Ibrahim Ali 7 Ahmed Elzayat - Dokki Giza Egypt
SPONSORS
Sponsor level Name Street address City Postal code Country Nature of sponsor
Primary Sponsor Faculty of Physical Therapy Cairo University El-Tahrir st. - in front of Ben El- Sarayat Traffic - Dokki - Giza Giza 11432 Egypt University
COLLABORATORS
Name Street address City Postal code Country
Fatma Elsayed Ibrahim Elsayed Hassan Elkasr El aini- Faculty of Medicine- Lecturer Giza Egypt
CONTACT PEOPLE
Role Name Email Phone Street address
Scientific Enquiries Fatma Elsayed Ibrahim Elsayed Hassan fatma.e.elsayed@kasralainy.edu.sa +201223154749 El Kasr Elainy
City Postal code Country Position/Affiliation
Giza Egypt lecturer at physiology department. faculty of medicine. Cairo University. Egypt
Role Name Email Phone Street address
Principal Investigator olfat Ibrahem Aly olfat_ib@cu.edu.eg +01001248426 7 Ahmed Elzayat
City Postal code Country Position/Affiliation
Giza Egypt Assistant Professor Basic sciences for Physical therapy Cairo University
Role Name Email Phone Street address
Public Enquiries Salaheldin B. Elsayed utcsalah@cu.edu.eg +201115018299 7 Ahmed Elzayat street
City Postal code Country Position/Affiliation
Giza Egypt Assistant Professor Basic sciences for Physical Therapy Cairo University
REPORTING
Share IPD Description Additional Document Types Sharing Time Frame Key Access Criteria
Yes One shot study- pre - post and after 30 min Study Protocol Before- immediately after and 30 minutes after the study done from February 2016 till June 2016 no follow up done Microcurrent electrical stimulation - Pressure pain threshold- NCV Evaluation of NCV and pressure pain threshold
URL Results Available Results Summary Result Posting Date First Journal Publication Date
Yes There was a significant difference between both groups concerning pain pressure threshold favouring study group (p value < 0.05), also there was a significant difference between pre and post measures of sensory nerve conduction velocity, and latency in study group (p value < 0.05). However there was no significant effect on median nerve motor parameters (p value > 0.05). 07/10/2016 07/10/2016
Result Upload 1: Result Upload 2: Result Upload 3: Result Upload 4: Result Upload 5:
Result URL Hyperlinks Link To Protocol
Result URL Hyperlinks https://www.researchgate.net/publication/333018275_INFLUENCE_OF_MICROCURRENT_ELECTRICAL_STIMULATION_ON_MEDIAN_NERVE_CONDUCTION_VELOCITY_AND_MECHANICAL_PAIN_THRESHOLD_A_RANDOMIZED_SINGLE_BLIND_CONTROLLED_TRIAL
Changes to trial information