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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: www.pactr.org
Trial no.:
PACTR201201000347595
Date registered:
2012/01/23
TRIAL DESCRIPTION
Public title
Role of Magnesium infusion in back pain
Official scientific title
The value of sequential intravenous and oral magnesium therapy in patients with chronic low back pain of neuropathic nature, Double blind, randomized study
Brief summary describing the background
and objectives of the trial
eighty patients with chronic low back pain with LANSS pain scale ¿12, receiving physical therapy program in the form of IFC and back muscles strengthening exercises was performed where forty patients received anticonvulsants, antidepressants and simple analgesics for 2 weeks (control group) the other forty patients received, in addition to group 1 treatment, intravenous magnesium infusion for two weeks, then infusion was stopped, and patients were given oral magnesium capsules for another four weeks (magnesium group).
Type of trial
RCT
Acronym (If the trial has an acronym then please provide)
Disease(s) or condition(s) being studied
Purpose of the trial
Treatment
Anticipated trial start date
2012-03-01
Actual trial start date
Anticipated date of last follow up
2012-07-01
Actual date of last follow up
Anticipated target sample size (number of participants)
80
Actual target sample size (number of participants)
Recruitment status
Not yet recruiting
Secondary Ids
Issuing authority/Trial register
Links to Secondary ID
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 randomisation using a radomisation table created by a computer software program
Sealed opaque envelopes
Masking/blinding used
INTERVENTIONS
Intervention type
Intervention name
Dose
Duration
Intervention description
Group size
Nature of control
Control group
Control
standard
2 weeks
physical therapy program in the form of IFC and back muscles strengthening exercises was performed where forty patients received anticonvulsants, antidepressants and simple analgesics for 2 weeks
40
Active
Experimental group
Magnesium
6 week regimen including IV and oral magnesium
6 weeks
receiving physical therapy program in the form of IFC and back muscles strengthening exercises was performed where forty patients received anticonvulsants, antidepressants and simple analgesics for 2 weeks plus intravenous magnesium for two weeks and oral magnesium capsules for the following four weeks
40
ELIGIBILITY CRITERIA
List inclusion criteria
List exclusion criteria
Min age
Max age
Gender
Chronic low back pain
acute back pain
18 Years
60 Years
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
2011/10/15
Ethical Committee of the Faculty of Medicine, Tanta University
Ethics Committee Address
Street address
City
Postal code
Country
Elgeish Street
Tanta
Egypt
OUTCOMES
Type of outcome
Outcome
Timepoint(s) at which outcome measured
Primary Outcome
Pain score
6 months
Secondary Outcome
Mobility of the spine
6 months
RECRUITMENT CENTRES
Name of recruitment centre
Street address
City
Postal code
Country
Tanta University Faculty of Medicine
Elgeish Street
Tanta
Egypt
FUNDING SOURCES
Name of source
Street address
City
Postal code
Country
Faculty of Medicine, Tanta University
Elgeish Street
Tanta
Egypt
SPONSORS
Sponsor level
Name
Street address
City
Postal code
Country
Nature of sponsor
Primary Sponsor
Faculty of Medicine, Tanta University
Elgeish Street
Tanta
Egypt
University
COLLABORATORS
Name
Street address
City
Postal code
Country
Ali Aldeb
Elguish Street
Tanta
Egypt
CONTACT PEOPLE
Role
Name
Email
Phone
Fax
Principal Investigator
Dr Ayman Yousef
ayman.yousef@rocketmail.com
00201003497767
0020403327747
Street address
City
Postal code
Country
Position / Affiliation
17 Elemam Moslem St
Tanta
Egypt
Assistant Prof of anesthesia
Role
Name
Email
Phone
Fax
Public Enquiries
Dr Ayman Abdalmaksoud Yousef
ayman.yousef@rocketmail.com
00201003497767
0020403327747
Street address
City
Postal code
Country
Position / Affiliation
17 Elemam Moslem St
Tanta
Egypt
Assistant Prof of anesthesia
Role
Name
Email
Phone
Fax
Scientific Enquiries
Dr Ayman Abdalmaksoud Yousef
ayman.yousef@rocketmail.com
00201003497767
0020403327747
Street address
City
Postal code
Country
Position / Affiliation
17 Elemam Moslem St
Tanta
Egypt
Assistant Prof of anesthesia