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.: PACTR201510001319256 Date of Approval: 24/10/2015
Trial Status: Retrospective registration - This trial was registered after enrolment of the first participant
TRIAL DESCRIPTION
Public title paraspinal kinsiotaping on low back pain patients.
Official scientific title Effect of paraspinal kinsiotaping on lumbar curvature and muscular fatigue in low back pain patients.
Brief summary describing the background and objectives of the trial In this study of people with chronic non-specific low back pain of mechanical aetiology, we compared the short-term effects of Kinesio Taping versus placebo tape application to the lumbar spine using EMG and three-dimensional motion analysis.
Type of trial RCT
Acronym (If the trial has an acronym then please provide)
Disease(s) or condition(s) being studied low back pain,Musculoskeletal Diseases
Sub-Disease(s) or condition(s) being studied
Purpose of the trial Treatment: Other
Anticipated trial start date 01/09/2015
Actual trial start date 02/09/2015
Anticipated date of last follow up 04/10/2015
Actual Last follow-up date 22/10/2015
Anticipated target sample size (number of participants) 50
Actual target sample size (number of participants) 50
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
Factorial: participants randomly allocated to either no, one, some or all interventions simultaneously Randomised using the numbered envelop method usnumbered envelop method Masking/blinding used Participants
INTERVENTIONS
Intervention type Intervention name Dose Duration Intervention description Group size Nature of control
Experimental Group group B paraspinal kinsiotaping 2 weeks apply kinsiotaping paravertebral for 2 weeks and measure lumar curvature and muscular fatique using three dimensional motion analysis 25
Control Group group A sham kinsiotaping 2 weeks apply sham kinsiotaping paravertebral for 2 weeks and measure lumar curvature and muscular fatique using three dimensional motion analysis 25 Placebo
ELIGIBILITY CRITERIA
List inclusion criteria List exclusion criteria Age Category Minimum age Maximum age Gender
25 ¿ 40 have had low back pain for at least 3 months, to be aged between 25 and 40 years, to score of four or more on the Roland-Morris Low Back Pain and Disability Questionnaire at randomization. ¿ Musculoskeletal or neurological injury with residual deficits, Previous surgery, Symptoms of nerve root engagement (i.e., pain distal to the knee), spondylolisthesis, spinal stenosis, Inflammatory disease and cancer, Metabolic or vascular disease with a neurological component such as diabetes or atherosclerosis. 25 Year(s) 40 Year(s) Male
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 03/09/2015 faculty of physical therapyethics committee
Ethics Committee Address
Street address City Postal code Country
ahmed elziat giza 32145 Egypt
OUTCOMES
Type of outcome Outcome Timepoint(s) at which outcome measured
Primary Outcome lumbar curvature and muscular fatique 2 weeks
Secondary Outcome pain 1 month
RECRUITMENT CENTRES
Name of recruitment centre Street address City Postal code Country
out patient clinic of kaser elani hospital elgaesh street cairo 54123 Egypt
FUNDING SOURCES
Name of source Street address City Postal code Country
faculty of physical therapy ahmed elziate giza 32145 Egypt
SPONSORS
Sponsor level Name Street address City Postal code Country Nature of sponsor
Primary Sponsor faculty of physical therapy, cairo university ahmed elziat giza 32154 Egypt University
COLLABORATORS
Name Street address City Postal code Country
mahmoud mohamed ahmed ewidea 3 elwahed st kaferelshiek 33512 Egypt
ahmed ebrahim elarian madii cairo 64213 Egypt
CONTACT PEOPLE
Role Name Email Phone Street address
Principal Investigator mahmoud ewidea mewidea@hotmail.com 00201005098423 3 elwehda st
City Postal code Country Position/Affiliation
kaferelshiek 33512 Egypt lecteure of physical therapy
Role Name Email Phone Street address
Principal Investigator ahmed elarian dr_ahmed_elerian@yahoo.com 0201118826276 madii
City Postal code Country Position/Affiliation
cairo 64213 Egypt lecteure of physical therapy
Role Name Email Phone Street address
Public Enquiries hany hamed hany_123@yahoo.com 0020123341383 elnaboi
City Postal code Country Position/Affiliation
kaferelelshiek 41235 Egypt lecteure of orthopedic surgery
Role Name Email Phone Street address
Scientific Enquiries mahmoud ewidea mewidea@hotmail.com 00201005098423 3 elwehda street
City Postal code Country Position/Affiliation
kaferelshiek 33512 Egypt Ass. prof
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