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.: PACTR201807754550712 Date of Approval: 30/07/2018
Trial Status: Registered in accordance with WHO and ICMJE standards
TRIAL DESCRIPTION
Public title EFFECT OF MAGNESIUM SULPHATE IONTOPHORESIS ON MYOFASCIAL TRIGGER POINTS IN UPPER FIBERS OF TRAPEZIUS: Randomized control trial
Official scientific title EFFECT OF MAGNESIUM SULPHATE IONTOPHORESIS ON MYOFASCIAL TRIGGER POINTS IN UPPER FIBERS OF TRAPEZIUS
Brief summary describing the background and objectives of the trial Myofascial trigger points (MTrPs) can be a significant source of pain. Up to 85% of people who present to pain clinics have MTrPs. The prevalence is greater in women than men and the frequency of locations are head/neck, shoulders, extremities, and low back, in that order. The most prevalent active MTrPs were located right (82.1%) and left (79%) in the nearly-horizontal fibers of the upper trapezius muscle. The iontophoretic deliveries of corticosteroids and NSAIDs are commonly used as a treatment in patients with musculoskeletal inflammatory disorders. Magnesium sulphate (MgS04) is a muscle relaxant and also a vasodilator. So the purpose of this study is to measure the effect of MgS04 iontophoresis in treatment of active trigger point in upper fiber of trapezius in subject with myofascial trigger points. A pilot study will be conducted to estimate the sample size. Before starting; they will be randomly allocated into 2 equal groups, group (A): subjects will receive MgSO4 iontophoresis on upper fiber of trapezius, group (B): subjects will receive direct current (without medication) on upper fiber of trapezius. Outcome measure would include: Pressure pain threshold (PPT): will be measured by electronic algometer, Functional disability: will be measured by Arabic Neck disability index (ANDI), Pain intensity: would be measured by visual analogue scale (VAS), Range of motion (ROM): by myrin gravity reference goniometer (OB goniometer). The assessment will be done at baseline and after the last treatment session.
Type of trial RCT
Acronym (If the trial has an acronym then please provide) MTrPs MgS04 PPT VAS ANDI ROM
Disease(s) or condition(s) being studied Musculoskeletal Diseases
Sub-Disease(s) or condition(s) being studied
Purpose of the trial Treatment: Other
Anticipated trial start date 25/07/2018
Actual trial start date
Anticipated date of last follow up 26/07/2018
Actual Last follow-up date
Anticipated target sample size (number of participants) 60
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 a randomization table created by a computer software program Numbered containers Open-label(Masking Not Used)
INTERVENTIONS
Intervention type Intervention name Dose Duration Intervention description Group size Nature of control
Experimental Group Group A 2 sessions per week 4 weeks will receive MgSO4 iontophoresis on upper fiber of trapezius. 30
Control Group Group B 2 session per week 4 weeks will receive direct current (without medication) on upper fiber of trapezius 30 Placebo
ELIGIBILITY CRITERIA
List inclusion criteria List exclusion criteria Age Category Minimum age Maximum age Gender
All patients have active MTrP in upper trapezius muscle complaining of pain at rest local twitch response jump sign limited ROM referred pain lies over the lateral aspect of the upper trapezius fibers and superiorly to the ipsilateral occiput The patients from both gender aged will be ranged from 18 to 25 years History of whiplash injury cervical spine surgery cervical radiculopathy myelopathy thyroid dysfunction chronic infection. Unstable or high blood pressure. Rheumatologic condition as mild systemic lupus erythematosus, poly-articular osteoarthritis, rheumatoid arthritis and advanced cervical spine degenerative diseases. Adult: 19 Year-44 Year 18 Year(s) 25 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
No 22/07/2018 Faculty of physical therapy research ethics
Ethics Committee Address
Street address City Postal code Country
7 Ahmed El Zayad street, Dooki, Giza, Egypt. Giza 12613 Egypt
OUTCOMES
Type of outcome Outcome Timepoint(s) at which outcome measured
Primary Outcome Pressure pain threshold Before treatment and after completion of the intervention
Secondary Outcome Pain intensity assessment Before treatment and after completion of intervention
Secondary Outcome Neck disability index Before treatment and after completion of intervention
Secondary Outcome cervical range of motion Before treatment and after completion of intervention
RECRUITMENT CENTRES
Name of recruitment centre Street address City Postal code Country
Faculty of physical therapy Cairo university 7 Ahmed El Zayad street, Dooki, Giza, Egypt. Giza Egypt
FUNDING SOURCES
Name of source Street address City Postal code Country
SPONSORS
Sponsor level Name Street address City Postal code Country Nature of sponsor
Primary Sponsor Cairo university 1 Gamaa Street, Giza Giza 12613 Egypt University
Primary Sponsor Faculty of physical therapy Cairo University 7 Ahmed El Zayad street, Dooki Giza 12613 Egypt University
COLLABORATORS
Name Street address City Postal code Country
CONTACT PEOPLE
Role Name Email Phone Street address
Principal Investigator Nouran Ahmed nornoribrahim@gmail.com +201062207203 219 area aien hadayek alahram
City Postal code Country Position/Affiliation
Giza Egypt Lecturer assistant at faculty of physical therapy Cairo university
Role Name Email Phone Street address
Public Enquiries Neveen Abd ElLatif Dr_neveen_69@yahoo.com +201064615553 1 Gamaa Street
City Postal code Country Position/Affiliation
Giza Egypt Professor of Basic Science Department Faculty of Physical Therapy Cairo University
Role Name Email Phone Street address
Scientific Enquiries Dalia Mosaad drdaliamosaad@gmail.com +201001469096 7 Ahmed El Zayad street, Dooki
City Postal code Country Position/Affiliation
Giza Egypt Assistant professor of Basic Science Department Faculty of Physical Therapy Cairo University
Role Name Email Phone Street address
Scientific Enquiries Shaimaa Taha dr.shymaelshazly@yahoo.com 01229823327 7 Ahmed El Zayad street, Dooki
City Postal code Country Position/Affiliation
Giza Egypt Lecturer of Basic Science Department Faculty of Physical Therapy Cairo University
REPORTING
Share IPD Description Additional Document Types Sharing Time Frame Key Access Criteria
Undecided
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