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.: PACTR201510001286134 Date of Approval: 29/09/2015
Trial Status: Retrospective registration - This trial was registered after enrolment of the first participant
TRIAL DESCRIPTION
Public title iontophoresis versus prolotherapy
Official scientific title A Randomized Controlled placebo study of Dextrose iontophoresis versus Dextrose prolotherapy in case of knee osteoarthritis
Brief summary describing the background and objectives of the trial we designed this study to investigate the effectiveness of dextrose iontophoresis versus dextrose polorotherapy in decreasing pain, improving daily functional ability, and increasing the joint range of motion (ROM) in patients with knee OA.
Type of trial RCT
Acronym (If the trial has an acronym then please provide)
Disease(s) or condition(s) being studied Musculoskeletal Diseases,osteoarthrities
Sub-Disease(s) or condition(s) being studied
Purpose of the trial Treatment: Other
Anticipated trial start date 03/02/2015
Actual trial start date 01/03/2015
Anticipated date of last follow up 08/09/2015
Actual Last follow-up date 14/09/2015
Anticipated target sample size (number of participants) 60
Actual target sample size (number of participants) 60
Recruitment status Completed
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 Randomization was allocated using the numbered envelop method. 20 Subjects were choosing for intraarticular while other 40 subjects were divided randomly into group A and C, subjects were blinded about which group they were allocated. numbered envelop method Masking/blinding used Participants
INTERVENTIONS
Intervention type Intervention name Dose Duration Intervention description Group size Nature of control
Experimental Group group A ) received iontophoresis of 50 % dextrose for 40 min 5 days per week for three months iontophoresis of 50 % dextrose 20
Experimental Group group B intra-articular injections of 50% dextrose three months intra-articular injections of 50% dextrose (prplotherapy) 20
Control Group group c sham iontophoresis three months sham exposure 20 Placebo
ELIGIBILITY CRITERIA
List inclusion criteria List exclusion criteria Age Category Minimum age Maximum age Gender
(a) moderate or moderate to severe knee OA (grade II or III according to the radiological classification of knee OA defined by Kellgren and Lawrence. (b) age between 45-65 years old (a) severe OA (grade IV according to the Kellgren¿Lawrence system of classification). (b) history of rheumatologic or inflammatory diseases; (c) received oral or systemic corticosteroids during the 2 weeks prior to treatment; (d) received an intra-articular injection of hyaluronic acid agents during the previous month; (e) poorly controlled diabetes mellitus with fasting blood sugar greater than 11.1 mmol/L; (f) history of anticoagulation therapy; (g) history of prior total knee replacement surgery. 45 Year(s) 65 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 15/09/2015 ethical committe of faculty of physical therapy
Ethics Committee Address
Street address City Postal code Country
giza, ahmed elziat street giza Egypt
OUTCOMES
Type of outcome Outcome Timepoint(s) at which outcome measured
Primary Outcome Knee ROM ,pain,stiffness and functional abilities initial evaluation (0) week. after 4 weeks. after 8 weeks. after 24 weeks.
Secondary Outcome walking ability (walking 6 M and then measure pain) at end of evaluation
RECRUITMENT CENTRES
Name of recruitment centre Street address City Postal code Country
orthopedic private clinic elkholfaa elrashdeen street kaferelshiek 33512 Egypt
outclinic of faculty of physical therapy elgaesh street kaferelshiek 33512 Egypt
FUNDING SOURCES
Name of source Street address City Postal code Country
no - - - Egypt
SPONSORS
Sponsor level Name Street address City Postal code Country Nature of sponsor
Primary Sponsor faculty of physical therapy, kaferelshiek university elgaesh street kaferelshiek 33512 Egypt University
COLLABORATORS
Name Street address City Postal code Country
mahmoud mohamed ahmed ewidea 3 elwehda street kaferelshiek 33512 Egypt
tamer mohamed ewidea salam square kaferelshiek 33512 Egypt
hesam gad gehan street kaferelshiek 33512 Egypt
CONTACT PEOPLE
Role Name Email Phone Street address
Principal Investigator mahmoud ewidea mewidea@hotmail.com 00201005098423 3 elwehda street
City Postal code Country Position/Affiliation
kaferelshiek 33512 Egypt lectruer of physical therapy,
Role Name Email Phone Street address
Public Enquiries amal fawzy dramalfawzy6@gmail.com 00201223819707 35 elgaesh street
City Postal code Country Position/Affiliation
kaferelshiek 33541 Egypt dean faculty of physical therapy, kaferelshiek university
Role Name Email Phone Street address
Scientific Enquiries tamer ewidea tamerewieda@yahoo.com 0021288280082 salam square
City Postal code Country Position/Affiliation
kaferelshiek 33512 Egypt ass. professor of anathesia
Role Name Email Phone Street address
Scientific Enquiries heasm gad hesam2015@yahoo.com 0020101503007 gehan street
City Postal code Country Position/Affiliation
kaferelshiek 33512 Egypt Ass.prof Dr. of orthopedic surgery
REPORTING
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Result URL Hyperlinks Link To Protocol
Result URL Hyperlinks
Changes to trial information