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.: PACTR201201000347595 Date of Registration: 23/01/2012
Trial Status: Registered in accordance with WHO and ICMJE standards
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 chronic back pain,Musculoskeletal Diseases
Sub-Disease(s) or condition(s) being studied
Purpose of the trial Treatment: Drugs
Anticipated trial start date 01/03/2012
Actual trial start date
Anticipated date of last follow up 01/07/2012
Actual Last follow-up date
Anticipated target sample size (number of participants) 80
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
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 Care giver/Provider,Participants
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-Treatment of Control Group
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 Age Category Minimum age Maximum age Gender
Chronic low back pain acute back pain 18 Year(s) 60 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 15/10/2011 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 Street address
Principal Investigator Ayman Yousef ayman.yousef@rocketmail.com 00201003497767 17 Elemam Moslem St
City Postal code Country Position/Affiliation
Tanta Egypt Assistant Prof of anesthesia
Role Name Email Phone Street address
Public Enquiries Ayman Abdalmaksoud Yousef ayman.yousef@rocketmail.com 00201003497767 17 Elemam Moslem St
City Postal code Country Position/Affiliation
Tanta Egypt Assistant Prof of anesthesia
Role Name Email Phone Street address
Scientific Enquiries Ayman Abdalmaksoud Yousef ayman.yousef@rocketmail.com 00201003497767 17 Elemam Moslem St
City Postal code Country Position/Affiliation
Tanta Egypt Assistant Prof of anesthesia
REPORTING
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URL Results Available Results Summary Result Posting Date First Journal Publication Date
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Result URL Hyperlinks Link To Protocol
Result URL Hyperlinks
Changes to trial information