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.: PACTR202310871277779 Date of Registration: 23/10/2023
Trial Status: Registered in accordance with WHO and ICMJE standards
TRIAL DESCRIPTION
Public title Electro acupuncture therapy for diplopia (Oculomotor and Abducent cranial nerves palsy)-A randomized controlled study
Official scientific title Electro acupuncture therapy for diplopia (Oculomotor and Abducent cranial nerves palsy)-A randomized controlled study
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 everyday tasks difficult to manage and even dangerous. The main reason of Diplopia is affection of the Oculomotor cranial nerves of the eye (the third (Oculomotor), the fourth (Trochlear) and the six (Abducens) Cranial Nerves) in isolation of each or combined. Agents for improving blood circulation, anti-inflammatory drugs, steroids, embolization therapy, and surgery are different modalities have been used to treat paralytic Diplopia depending on the etiology. However, many cases are managed symptomatically while waiting for spontaneous recovery. But some of them had unsatisfied efficacy and adverse events. Traditional Chinese medicine (TCM) offers treatment methods that may manage the distressing symptoms of palsy, in addition to conventional Western interventions. Therefore, integration of methods such as acupuncture may be worth investigating. Acupuncture therapy is used to treat various conditions, such as pain, stroke rehabilitation, urinary dysfunction, pressure ulcers, and DP. Several clinical studies support the idea that acupuncture may help treat the symptoms of DP. PURPOSE: To examine the effect of acupuncture therapy for patients suffered from diplopia using objective evaluative procedure.
Type of trial RCT
Acronym (If the trial has an acronym then please provide)
Disease(s) or condition(s) being studied Eye Diseases,Nervous System Diseases
Sub-Disease(s) or condition(s) being studied
Purpose of the trial electro acupuncture therapy
Anticipated trial start date 11/10/2023
Actual trial start date 11/10/2023
Anticipated date of last follow up 11/01/2024
Actual Last follow-up date
Anticipated target sample size (number of participants) 42
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 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
Experimental Group standard prophylactic medications in addition to electro acupuncture therapy. standard prophylactic medications once daily of pyridostigmine (Mestinon) of 5 ng/ml and corticosteroids of 5 mcg/dL electro acupuncture therapy input power 6V,A wave; intermittent- intensity adjusted according to patient’s tolerance standard prophylactic medications once daily for 4 weeks electro acupuncture therapy for 25 minute / day after day session for 12 regular sessions ( 4 weeks) standard prophylactic medications includes pyridostigmine (Mestinon) as well as corticosteroids electro acupuncture therapy , at points selected for treating double vision. (BL1, BL2, ST2, GB14, Yuyao (extraordinary head point n.4), Taiyang (extraordinary point n. 5) and DU20. 20
Control Group standard prophylactic medications once daily of pyridostigmine (Mestinon) of 5 ng/ml and corticosteroids of 5 mcg/dL 4 weeks pyridostigmine (Mestinon) as well as corticosteroids 22 Active-Treatment of Control Group
ELIGIBILITY CRITERIA
List inclusion criteria List exclusion criteria Age Category Minimum age Maximum age Gender
1. Patients diagnosed with Diplopia (double vision). 2. Patients with controlled blood glucose levels (HbA1C <48 mmol/mol). 3. Patients with controlled blood pressure (BP) ≤ 150/90 mmHg. 1. Any other eye diseases. 2. Any eye complications. 3. Or undergoing ophthalmic surgery from the current study. Aged: 65 Year(s)-79 Year(s),Middle Aged: 45 Year(s)-64 Year(s) 50 Year(s) 70 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 18/07/2023 Research ethical committee of Faculty of Physical Therapy Cairo University
Ethics Committee Address
Street address City Postal code Country
Ben El- Sarayat Traffic, Ad Doqi, Giza District, Giza Cairo 11432 Egypt
OUTCOMES
Type of outcome Outcome Timepoint(s) at which outcome measured
Primary Outcome Hess screen test by Hess screen (HAAG-STRIET, UK), red-green Go glass, red and green pointer to ssess the ocular alignment in three dimensions with high precision. Before treatment and After treatment
Secondary Outcome Visual acuity will clinically evaluated by the Ophthalmogist Before treatment and after treatment
RECRUITMENT CENTRES
Name of recruitment centre Street address City Postal code Country
Kobri El Koba Military Hospital Kobry El Qobba St. Cairo Egypt
FUNDING SOURCES
Name of source Street address City Postal code Country
Amir N Wadee 51 Toson st Shobra Cairo Egypt
SPONSORS
Sponsor level Name Street address City Postal code Country Nature of sponsor
Primary Sponsor Amir N Wadee 51 Toson st.Shobra Cairo Egypt Individual
Secondary Sponsor Siham M Fahmy 40 Masarra Shobra Cairo Egypt Individual
COLLABORATORS
Name Street address City Postal code Country
Amir N Wadee 51 Toson St. Shobra Cairo Egypt
Siham M Fahmy 40 Masarra Shobra Cairo Egypt
CONTACT PEOPLE
Role Name Email Phone Street address
Principal Investigator Amir N Wadee anazih@cu.edu.eg 01222367919 51 Toson St. Shobra
City Postal code Country Position/Affiliation
Cairo Egypt Professor of Basic Sciences of Physical Therapy Cairo University
Role Name Email Phone Street address
Public Enquiries Siham M Fahmy Fahmysiham@gmail.com 1279107651 40 Masarra st. Shobra
City Postal code Country Position/Affiliation
Cairo Egypt Associate professor of physical therapy
Role Name Email Phone Street address
Scientific Enquiries Alaa Anwar Ahmed Aalaa.anwar222@gmail.com 01002538439 3 Ebn Taimia New El Sharawy
City Postal code Country Position/Affiliation
Cairo Egypt Lecturer at department of Physical Therapy of integumentary Egyptian Chinese University
REPORTING
Share IPD Description Additional Document Types Sharing Time Frame Key Access Criteria
Yes All of the individual participant data collected during the trial, after deidentification. Individual participant data that underlie the results reported in this article, after deidentification (text, tables, figures, and appendices). Individual participant data that underlie the results reported in this article, after deidentification (text, tables, figures, and appendices). Informed Consent Form,Statistical Analysis Plan,Study Protocol 6-12 months Open access of data analysis documents permitted when requesting from authors
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