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.: PACTR202011764107216 Date of Approval: 05/11/2020
Trial Status: Registered in accordance with WHO and ICMJE standards
TRIAL DESCRIPTION
Public title Transcranial Direct Current Stimulation (tDCS) on post mastectomy pain Syndrome
Official scientific title Transcranial Direct Current Stimulation (tDCS) on post mastectomy pain Syndrome
Brief summary describing the background and objectives of the trial The purpose of the study is to investigate the effect of anodal tDCS of the motor cortex (M1) in Post-mastectomy pain syndrome.
Type of trial RCT
Acronym (If the trial has an acronym then please provide)
Disease(s) or condition(s) being studied Cancer
Sub-Disease(s) or condition(s) being studied
Purpose of the trial Treatment: Devices
Anticipated trial start date 20/12/2019
Actual trial start date 01/01/2021
Anticipated date of last follow up 01/09/2021
Actual Last follow-up date 01/04/2022
Anticipated target sample size (number of participants) 30
Actual target sample size (number of participants) 30
Recruitment status Completed
Publication URL
Secondary Ids Issuing authority/Trial register
P.T.REC 012 002945 Cairo University Faculty Of Physical Therapy Research Ethical Committee
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,Participants
INTERVENTIONS
Intervention type Intervention name Dose Duration Intervention description Group size Nature of control
Control Group transcranial direct current stimulation on motor cortex bilaterally of postmastectomy pain syndrome direct current is applied with intensity 2 mA for 5 minutes bilaterally on the motor cortex (M1). The patient received 5 sessions 5 days Sham transcranial direct current stimulation will be applied to patients including 5 sessions in 5 days. Each stimulation lasts for 5 minutes. Electrodes are placed on the motor cortex (M1) bilateral using the Caputron universal strap. The direct current will be applied with intensity 2mA, with electrodes sized 2" x 2". The patient will be in a sitting position. The patient will be assessed pre and post-treatment for neuropathic pain, depression, Anxiety, and all shoulder range of motion. 1. to apply Transcranial direct current stimulation we will use Transcranial current direct stimulation device: Caputron, “ActivaDose II tDCS Device”, U.S.A 2. to measure neuropathic pain, the shoulder range of motion, depression, and anxiety we will use the following: A) Electronic goniometer: measure the shoulder range of motion. B) Neuropathic pain: DN4 score. C) Depression: Beck-Depression-Inventory-BDI. D) Anxiety: Taylor Manifest Anxiety Scale. 15 Placebo
Experimental Group transcranial direct current stimulation on motor cortex bilaterally of postmastectomy pain syndrome Transcranial Direct Current Stimulation applied with intensity 2mA for 20 minutes for five sessions. 5 days. Transcranial direct current stimulation applied 5 sessions for 5 das. Each stimulation lasted for 20 minutes. Electrodes are placed on the motor cortex (M1) bilateral using the Caputron universal strap. The direct current will be applied with intensity 2mA, with electrodes sized 2" x 2". The patient will be in a sitting position. The patient will be assessed pre and post treatment for neuropathic pain, depression, Anxiety, and all shoulder range of motion. 1. to apply Transcranial direct current stimulation we will use Transcranial current direct stimulation device: Caputron, “ActivaDose II tDCS Device”, U.S.A 2. to measure neuropathic pain, the shoulder range of motion, depression, and anxiety we will use the following: A) Electronic goniometer: measure the shoulder range of motion in all directions. B) Neuropathic pain: DN4 score. C) Depression: Beck-Depression-Inventory-BDI. D) Anxiety: Taylor Manifest Anxiety Scale. 15
ELIGIBILITY CRITERIA
List inclusion criteria List exclusion criteria Age Category Minimum age Maximum age Gender
Women with post mastectomy pain syndrome - Chance of pregnancy. - A history of migraines. -If contact with the scalp is not possible (e.g., head scarf or dreadlocks). -Scalp or skin condition (e.g., psoriasis or eczema). -Metallic implants, including intracranial electrodes, surgical clips, shrapnel or a pacemaker. Or any metallic accessories or cloth. -Head injury resulting in a loss of consciousness that has required further investigation (e.g., a brain scan). -Seizure -They are on prescriptive medication, or are self-medicating, apart from the contraceptive pill. -Epilepsy or a history of epilepsy. -Medical diagnoses of psychological or neurological disorders. Adult: 19 Year-44 Year,Aged: 65+ Year(s),Middle Aged: 45 Year(s)-64 Year(s) 25 Year(s) 69 Year(s) Female
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 11/10/2020 Cairo University 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 Giza 11432 Egypt
OUTCOMES
Type of outcome Outcome Timepoint(s) at which outcome measured
Primary Outcome assessing neuropathic pain level neuropathic pain will be assessed pre and post treatment intervention
Secondary Outcome assessing level of depression depression will be assessed pre and post treatment intervention
Secondary Outcome assessing anaxiety anaxiety will be assessed pre and post treatment intervention
Primary Outcome Shoulder range of motion will be assessed pre and post every session. shoulder range of motion of motion will be assessed by Electronic goniometer.
RECRUITMENT CENTRES
Name of recruitment centre Street address City Postal code Country
IPC Physical Therapy Center 5 Moharram Shawqi, El-Montaza, Heliopolis. Cairo Governorate 0000 Egypt
FUNDING SOURCES
Name of source Street address City Postal code Country
Mira Hany Zaky Hanna 23 B Nasouh, El-Zaytoun Sharkeya, El-Zaytoun. Cairo Governorate 00000 Egypt
SPONSORS
Sponsor level Name Street address City Postal code Country Nature of sponsor
Primary Sponsor Mira Hanny Zaky Hanna 23 B, Nesouh street, Al Zaitoun Cairo 0000 Egypt Individual
COLLABORATORS
Name Street address City Postal code Country
CONTACT PEOPLE
Role Name Email Phone Street address
Principal Investigator Mira Hanna mirazaki25@gmail.com +201276153155 23 B , Nesouh street, Al Zaitoun
City Postal code Country Position/Affiliation
Cairo 0000 Egypt Physical therapist
Role Name Email Phone Street address
Public Enquiries Mira Hanna mrazaki25@gmail.com +201276153155 23 B, Nesouh street, Al Zaitoun
City Postal code Country Position/Affiliation
Cairo 0000 Egypt Physical therapist
Role Name Email Phone Street address
Scientific Enquiries Mira Hanna mirazaki25@gmail.com +201276153155 23 B, Nesouh street, Al Zaitoun
City Postal code Country Position/Affiliation
Cairo 0000 Egypt physical therapist
REPORTING
Share IPD Description Additional Document Types Sharing Time Frame Key Access Criteria
Yes Individual participant data will be available including participant data collected during the trial after de-identification. Clinical Study Report,Informed Consent Form,Statistical Analysis Plan,Study Protocol The data will be available immediately following publication. Anyone can access the data for any purpose.
URL Results Available Results Summary Result Posting Date First Journal Publication Date
Data will be available indefinitely at (link to be included later). 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