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.: PACTR202102482678855 Date of Registration: 25/02/2021
Trial Status: Registered in accordance with WHO and ICMJE standards
TRIAL DESCRIPTION
Public title Influence of Electro-Acupuncture on Diplopia in Patients with Occular Nerve Palsy
Official scientific title Influence of Electro-Acupuncture on Diplopia in Patients with Occular Nerve Palsy
Brief summary describing the background and objectives of the trial Diplopia (DP), the most commonly seen manifestation in patient with ocular motility disorders, is a serious problem among patients with diabetes mellitus, stroke, cerebral tumours, and traumatic brain injury. Diplopia can significantly affect the person’s quality of life, making simple every¬day tasks difficult to manage and even dangerous. It commonly affected the oculomotor and abducens cranial nerves (III and VI CN). In addition, these patients may also develop diplopia (DP). Abducens palsy, also known as sixth nerve palsy, is a dysfunction of cranial nerve VI, which is responsible for contracting the lateral rectus muscle to abduct the eye. Patients with abducens palsy have horizontal diplopia that worsens with gaze toward the paretic lateral rectus muscle. The condition is commonly unilateral but can also occur bilaterally.
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 ELECTRO-ACUPUNCTURE
Anticipated trial start date 20/02/2021
Actual trial start date
Anticipated date of last follow up 01/05/2021
Actual Last follow-up date
Anticipated target sample size (number of participants) 40
Actual target sample size (number of participants)
Recruitment status Not yet 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
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 Participants
INTERVENTIONS
Intervention type Intervention name Dose Duration Intervention description Group size Nature of control
Control Group standard medications tetracycline twice daily Methycobal twice daily vitamin B12 once daily four weeks tetracycline twice daily Methycobal twice daily vitamin B12 once daily 20 Active-Treatment of Control Group
Experimental Group electro acupuncture for 25 minutes, day after day session, for 12 regular sessions. 4 weeks Acupuncture point's locations, angle of insertion and depth of insertion are summarized in (Table 2). Manipulation of each needle (Sterilized disposable stainless steel acupuncture needles size 0.3mm in diameter and 25 mm length) till the arrival of Qi , Rotate the needle back and forth to reinforce Qi in the meridian every 5 minute during the session 20
ELIGIBILITY CRITERIA
List inclusion criteria List exclusion criteria Age Category Minimum age Maximum age Gender
1- Patients must have controlled blood glucose levels (HbA1C <48 mmol/mol). 2- Patients must have blood pressure (BP) ≤ 150/90 mmHg. , 1- exclude any patient suffered from any eye diseases, 2-exclude any patient with eye complications 3- exclude any patient undergoing ophthalmic surgery. Middle Aged: 45 Year(s)-64 Year(s) 45 Year(s) 64 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 19/01/2021 Ethical Committee of Faculty of Physical Therapy Cairo University
Ethics Committee Address
Street address City Postal code Country
El-Tahrir st. in front of Ben El- Sarayat Traffic, Ad Doqi, Giza District, Giza Governorate Cairo 11432 Egypt
OUTCOMES
Type of outcome Outcome Timepoint(s) at which outcome measured
Primary Outcome Hess screen test before-treatment and after 4 months-treatment
Secondary Outcome Diplopia Questionnaire before-treatment and after 4 months-treatment
RECRUITMENT CENTRES
Name of recruitment centre Street address City Postal code Country
Acupuncture clinic Kobri El-Koba Military Hospital Cairo Egypt Kobry El Qobba St. KOBRY EL KOBA Heliopolis Cairo Governorate Cairo Egypt
FUNDING SOURCES
Name of source Street address City Postal code Country
Amir N Wadee 51 Toson st. Shoubra Cairo Egypt
SPONSORS
Sponsor level Name Street address City Postal code Country Nature of sponsor
Primary Sponsor Amir N Wadee 51 Toson st. Shoubra Cairo Egypt Individual
COLLABORATORS
Name Street address City Postal code Country
Amir N Wadee 51 Ebn Fadle Toson Shoubra Cairo Egypt
Seham Fahmy Kobry El Qobba St. KOBRY EL KOBA Heliopolis, Cairo Governorate Cairo Egypt
CONTACT PEOPLE
Role Name Email Phone Street address
Principal Investigator Amir N Wadee anazih@cu.edu.eg 01222367919 51 Toson St. Shoubra
City Postal code Country Position/Affiliation
Cairo Egypt Assistant Professor of Physical Therapy
Role Name Email Phone Street address
Public Enquiries Seham Fahmy fahmysiham@gmail.com 01272346919 Kobry El Qobba St. KOBRY EL KOBA Heliopolis, Cairo Governorate
City Postal code Country Position/Affiliation
Cairo Egypt Lecturer of Physical Therapy
Role Name Email Phone Street address
Scientific Enquiries Amir N Wadee anazih@cu.edu.eg 01222367919 51 Toson St. Shoubra
City Postal code Country Position/Affiliation
Cairo Egypt Assistant Professor of Physical Therapy
REPORTING
Share IPD Description Additional Document Types Sharing Time Frame Key Access Criteria
Yes International peer-reviewed scientific journal Clinical Study Report,Informed Consent Form,Statistical Analysis Plan,Study Protocol 12 months open access for all the research article, including the data analysis will be permitted. The email is provided for requesting the document
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