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