Evaluation of the effectiveness of magnesium prescription on the severity of pain and spasticity in patients with cerebral palsy
Design
Clinical trial without control group, single, not blinded, not randomized
Settings and conduct
31 patients with spastic cerebral palsy who referred to Shah-Vali and Shohada-e-Kargar hospitals of Yazd during 7 months were included. Patients received 100-300 mg of magnesium powder daily for 6 weeks.
Participants/Inclusion and exclusion criteria
Inclusion criteria: 2 to 17 years old patients with spastic cerebral palsy
Exclusion criteria: botox injection for at least 6 months, use of muscle relaxants and patients under 2 and over 17 years of age.
Intervention groups
Inclusion criteria: Patients with spastic cerebral palsy
Exclusion criteria: Patients received 100-300 mg of magnesium powder daily for 6 weeks.
Main outcome variables
the severity of pain (FPS), Spasticity (MAS)
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20190817044550N1
Registration date:2020-02-01, 1398/11/12
Registration timing:retrospective
Last update:2020-02-01, 1398/11/12
Update count:0
Registration date
2020-02-01, 1398/11/12
Registrant information
Name
Mohammad Hoseini
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 21 8950 2504
Email address
meditorha@gmail.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2019-01-21, 1397/11/01
Expected recruitment end date
2019-08-23, 1398/06/01
Actual recruitment start date
2019-01-21, 1397/11/01
Actual recruitment end date
2019-08-23, 1398/06/01
Trial completion date
2019-10-07, 1398/07/15
Scientific title
Effect of Magnesium on the Severity of Pain and Spasticity in Patients with Cerebral Palsy
Public title
Effect of Magnesium on Severity of Pain and Spasticity
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
patients with spastic cerebral palsy
children in the age of 2 to 17 years old
Exclusion criteria:
Botox injection for at least 6 months
The use of muscle relaxant drugs
Age
From 2 years old to 17 years old
Gender
Both
Phase
2
Groups that have been masked
No information
Sample size
Target sample size:
31
Actual sample size reached:
31
Randomization (investigator's opinion)
N/A
Randomization description
Blinding (investigator's opinion)
Not blinded
Blinding description
Placebo
Not used
Assignment
Single
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics committee of Islamic Azad University of Yazd
Street address
Shohada-e-Gomnam Blvd., Safaeih, Yazd
City
Yazd
Province
Yazd
Postal code
8916871967
Approval date
2019-06-25, 1398/04/04
Ethics committee reference number
IR.IAU.KHUISF.REC.1398.105
Health conditions studied
1
Description of health condition studied
cerebral palsy
ICD-10 code
ICD-10 code description
Primary outcomes
1
Description
Faces Pain Scale scores
Timepoint
6 months after patients entered to the study
Method of measurement
FPS test
2
Description
Modified Ashworth scale scores
Timepoint
6 months after patients entered to the study
Method of measurement
MAS test
Secondary outcomes
empty
Intervention groups
1
Description
The intervention group consisted of 30 eligible patients and the intervention was administered daily for 100–300 mg magnesium sulfate daily for 6 weeks, but given that our statistical population was children so we used magnesium powder.
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
Shah-Vali Hospital
Full name of responsible person
Ahmad Shajari
Street address
Shohada-e-Gomnam Blvd., Safayie, Yazd
City
Yazd
Province
Yazd
Postal code
8916871967
Phone
+98 35 3187 2200
Email
a_shajari@iauyazd.ac.ir
2
Recruitment center
Name of recruitment center
Shohada-e-Kargar Hospital
Full name of responsible person
Ahmad Shajari
Street address
Modarres Blvd., Akramieh, Yazd
City
Yazd
Province
Yazd
Postal code
۸۹۴۴۱۶۳۱۱۴
Phone
+98 35 3182 2000
Email
a_shajari@iauyazd.ac.ir
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Sponsor Vice-chancellor of research, Islamic Azad University, Faculty of Medicine, Branch of Yazd
Full name of responsible person
Ahmad Shajari
Street address
Shohada-e-Gomnam Blvd., Safayie,YAzd
City
Yazd
Province
Yazd
Postal code
8916871967
Phone
+98 35 3187 2200
Email
a_shajari@iauyazd.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
No
Title of funding source
Islamic Azad University
Proportion provided by this source
100
Public or private sector
Public
Domestic or foreign origin
Domestic
Category of foreign source of funding
empty
Country of origin
Type of organization providing the funding
Academic
Person responsible for general inquiries
Contact
Name of organization / entity
Islamic Azad University
Full name of responsible person
Ahmad Shajari
Position
Assistant professor
Latest degree
Subspecialist
Other areas of specialty/work
Pediatrics
Street address
Shohada-e-Gomnam Blvd., Safahiye, Yazd
City
Yazd
Province
Yazd
Postal code
8916871967
Phone
+98 35 3187 2200
Email
a_shajari@iauyazd.ac.ir
Person responsible for scientific inquiries
Contact
Name of organization / entity
Islamic Azad University
Full name of responsible person
Ahmad Shajari
Position
Assistant professor
Latest degree
Subspecialist
Other areas of specialty/work
Pediatrics
Street address
Shohada-e-Gomnam Blvd., Safayie, Yazd
City
Yazd
Province
Yazd
Postal code
8916871967
Phone
+98 35 3187 2200
Email
a_shajari@iauyazd.ac.ir
Person responsible for updating data
Contact
Name of organization / entity
Islamic Azad University
Full name of responsible person
Ahmad Shajari
Position
Assistant professor
Latest degree
Subspecialist
Other areas of specialty/work
Pediatrics
Street address
Shahada-e-Gomnam Blvd., Safayie, Yazd
City
Yazd
Province
Yazd
Postal code
8916871967
Phone
+98 35 3187 2200
Email
a_shajari@iauyazd.ac.ir
Sharing plan
Deidentified Individual Participant Data Set (IPD)
Undecided - It is not yet known if there will be a plan to make this available
Study Protocol
No - There is not a plan to make this available
Statistical Analysis Plan
No - There is not a plan to make this available
Informed Consent Form
No - There is not a plan to make this available
Clinical Study Report
Undecided - It is not yet known if there will be a plan to make this available
Analytic Code
Undecided - It is not yet known if there will be a plan to make this available
Data Dictionary
Undecided - It is not yet known if there will be a plan to make this available