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.: PACTR202011730065910 Date of Approval: 02/11/2020
Trial Status: Retrospective registration - This trial was registered after enrolment of the first participant
TRIAL DESCRIPTION
Public title Repetitive Transcranial Magnetic Stimulation versus Transcranial Direct Current Stimulation on Lumbar Radiculopathy
Official scientific title Repetitive Transcranial Magnetic Stimulation versus Transcranial Direct Current Stimulation on Lumbar Radiculopathy
Brief summary describing the background and objectives of the trial Background:- Lumbar radiculopathy is a term used to describe a pain syndrome caused by compression or irritation of nerve roots in the lower back. It can be caused by lumbar disc herniation, degeneration of the spinal vertebra, and narrowing of the foramen from which the nerves exit the spinal canal. Objective:- To compare the effect of repetitive transcranial magnetic stimulation to that of transcranial direct current stimulation in improving pain of unilateral lumbar radiculopathy.
Type of trial RCT
Acronym (If the trial has an acronym then please provide)
Disease(s) or condition(s) being studied Nervous System Diseases
Sub-Disease(s) or condition(s) being studied
Purpose of the trial Rehabilitation
Anticipated trial start date 05/05/2019
Actual trial start date 02/06/2019
Anticipated date of last follow up 30/05/2021
Actual Last follow-up date
Anticipated target sample size (number of participants) 64
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
Crossover: all participants receive all interventions in different sequence during study 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 repetitive transcranial magnetic stimulation plus conventional physical therapy program. - Each patient will receive 6 sessions of rTMS every other day in addition to 12 sessions of the conventional physical therapy program every other day Each patient will receive 6 sessions of rTMS for 2 weeks in addition to 12 sessions of the conventional physical therapy program for 4 weeks. - Patients will sit in a comfortable reclining chair and will be asked to keep their hands relaxed. - Resting motor threshold will be detected in the abductor policis brevis according to the method described by - Repetitive magnetic stimulation will be applied using a figure-of-eight coil oriented at 45ᵒ to the inter hemispheric fissure with the handle directed backwards. The intervention consists of real or sham rTMS of (M1) contralateral to the painful side. It will be given in series of 20 trains of 6 seconds duration, with an inter-train interval of 54 seconds and intensity 90% of motor threshold at a stimulation rate of 10 Hz (1200 pulses) for 20 minutes per day Exercises program:- - Back exercises with 10 repetition of each in the form of:-  Prone on elbows.  Prone on hands.  Progress to extension back with hands behind the back. - Bridging exercises - Quadriped exercises with extension of unilateral lower limb alternately. 20
Experimental Group transcranial direct current stimulation plus conventional physical therapy program . - Each patient will receive 6 sessions of tDCS (Group B) every other day in addition to 12 sessions of the conventional physical therapy program every other day for 2 weeks in addition to 12 sessions of the conventional physical therapy program for 4 weeks. - Patients will set in a comfortable reclining chair. - The anode will be placed over C3 or C4 to target M1 contralateral to the painful side and the cathode will be placed over the chin. A constant current of 2 mA intensity will be applied for 20 minutes Exercises program:- - Back exercises with 10 repetition of each in the form of:-  Prone on elbows.  Prone on hands.  Progress to extension back with hands behind the back. - Bridging exercises - Quadriped exercises with extension of unilateral lower limb alternately. 20
Control Group sham intervention plus conventional physical therapy program. - Each patient in Group (C) will receive 6 sessions of sham intervention of (rTMS) and (tDCS) every other day in addition to 12 sessions of conventional physical therapy program every other day Each patient in Group (C) will receive 6 sessions of sham intervention of (rTMS) and (tDCS) for 2 weeks in addition to 12 sessions of conventional physical therapy program for 4 weeks. - Repetitive magnetic stimulation will be applied using a figure-of-eight sham coil oriented at 45ᵒ to the inter hemispheric fissure with the handle directed backwards. The intervention consists of sham rTMS of (M1) contralateral to the painful side. It will be given in series of 20 trains of 6 seconds duration, with an inter-train interval of 54 seconds and intensity 90% of motor threshold at a stimulation rate of 10 Hz (1200 pulses) for 20 minutes per day - The anode will be placed over C3 or C4 to target M1 contralateral to the painful side and the cathode will be placed over the chin. A constant current of 2 mA intensity will be applied for 20 minutes transcranial direct current stimulation 24 Placebo
ELIGIBILITY CRITERIA
List inclusion criteria List exclusion criteria Age Category Minimum age Maximum age Gender
• Sixty four patients from both genders suffering from lumber disc lesion (L4, 5 - S1) with unilateral sciatic pain • Sixty four patients from both genders suffering from lumber disc lesion (L4, 5 - S1) with unilateral sciatic painradiated down to the foot. • The age ranges between 20 to 45 years old. • Persistent pain for at least three months. • Patients with intact cognitive function. • Patients with other neurological or psychiatric disorders (depression, past head trauma, epilepsy, , intracranial hypertension) • Patients with past neurosurgical intervention or implanted devices. • Patients with tumors or autoimmune diseases. • Patients with other severe musculoskeletal pain. • Diabetic patients. • Cognitive impairment or intellectual disability. • Pregnant women. Adult: 19 Year-44 Year 20 Year(s) 40 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 05/05/2019 faculty of physical therapy research ethical committee
Ethics Committee Address
Street address City Postal code Country
El-Tahrir st. - in front of Ben El- Sarayat Traffic - Dokki - Giza, Giza District, cairo 11432 Egypt
OUTCOMES
Type of outcome Outcome Timepoint(s) at which outcome measured
Primary Outcome reduction of pain one month
Secondary Outcome range of motion of hip flexion 1 month
RECRUITMENT CENTRES
Name of recruitment centre Street address City Postal code Country
Ain Shams hospital Abasia square cairo Egypt
FUNDING SOURCES
Name of source Street address City Postal code Country
principle investigator shebin el kom monofya 1123 Egypt
SPONSORS
Sponsor level Name Street address City Postal code Country Nature of sponsor
Primary Sponsor ain shams university abbasia square cairo 54218 Egypt University
COLLABORATORS
Name Street address City Postal code Country
Alaa Amgad Alzahaby ain shams cairo 766554 Egypt
shady samy abdel said ain shams cairo 2234 Egypt
ahmed shawky nasr street cairo 11243 Egypt
CONTACT PEOPLE
Role Name Email Phone Street address
Principal Investigator Mona mohamed dr_m_elsheikh83@yahoo.com 01008773688 12 Abu Yousef street shebin el kom
City Postal code Country Position/Affiliation
Monofiya 11235 Egypt Principal investigator
Role Name Email Phone Street address
Scientific Enquiries Waleed Mansour dr_waleed_mansour73@yahoo.com 01005311168 fahmy street -quesna
City Postal code Country Position/Affiliation
monofiya 54441 Egypt professor
Role Name Email Phone Street address
Public Enquiries Nevine El Nahas nevineelnahas30@yahoo.com 01227910517 nagy street masr gedida
City Postal code Country Position/Affiliation
cairo 21158 Egypt professor
Role Name Email Phone Street address
Scientific Enquiries Gehan Nour Gehannour@gmail.com 01067841415 Al Rehab City. group 71. building 8. flat 1
City Postal code Country Position/Affiliation
cairo 11841 Egypt head of department of neuromuscular disorders and its surgery.faculty of physical therapy . Cairo university
REPORTING
Share IPD Description Additional Document Types Sharing Time Frame Key Access Criteria
Yes protocol details, primary and secondary outcome measures Study Protocol two years from completion of the study controlled access decided by the responsible author
URL Results Available Results Summary Result Posting Date First Journal Publication Date
No
Result Upload 1: Result Upload 2: Result Upload 3: Result Upload 4: Result Upload 5:
Result URL Hyperlinks Link To Protocol
Result URL Hyperlinks
Changes to trial information