Pan African Clinical Trials Registry
South African Medical Research Council, South African Cochrane Centre
PO Box 19070, Tygerberg, 7505, South Africa
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Email: pactradmin@mrc.ac.za Website: pactr.samrc.ac.za
Trial no.: PACTR201508001226124 Date of Approval: 06/08/2015
Trial Status: Retrospective registration - This trial was registered after enrolment of the first participant
TRIAL DESCRIPTION
Public title kinesio taping and postural exercises for neck pain
Official scientific title Efficacy of Kinesio Taping and Postural Correction Exercises on Mechanical Neck Dysfunction: A Randomized Blinded Clinical Trial
Brief summary describing the background and objectives of the trial Objective: to investigate the effect of kinesio taping and/or postural correction exercises on pain intensity, neck disability, and cervical spine curvature in individuals with mechanical neck dysfunction (MND). Design: A pre and post treatment test randomized blinded clinical trial with three parallel groups. Setting: outpatient clinic of faculty of physical therapy, cairo university. Participants: Ninety five patients (55 females), age (20-35) with MND were randomly assigned in to 1 of 3 groups. Interventions: 4 weeks treatment; group A: received kinesio taping on the cervical region from insertion to origin, group B: postural correction exercises in form of cervical and scapular retractions, and C: both. Main Outcome Measures: Pain intensity, Neck disability and cervical curve were measured pre and post treatment.
Type of trial RCT
Acronym (If the trial has an acronym then please provide)
Disease(s) or condition(s) being studied Musculoskeletal Diseases,neck pain
Sub-Disease(s) or condition(s) being studied
Purpose of the trial Physical activity and nutrition
Anticipated trial start date 10/04/2014
Actual trial start date 24/04/2014
Anticipated date of last follow up 06/05/2015
Actual Last follow-up date 13/05/2015
Anticipated target sample size (number of participants) 90
Actual target sample size (number of participants) 95
Recruitment status Stopped early/ terminated
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 randomization using a randomization table created by a computer software program Sealed opaque envelopes Masking/blinding used Outcome Assessors
INTERVENTIONS
Intervention type Intervention name Dose Duration Intervention description Group size Nature of control
Experimental Group kinesio taping with postural correction exercises twice a week 4 weeks patients performed scapular and cervical retraction exercises for 10 seconds with kinesio tape applied to cervical muscles from insertion to origin 32 Active-Treatment of Control Group
Experimental Group cervical kinesio taping twice a week 4 weeks 2 kinesio tape strips: first: y strip applied on cervical musculature from insertion to origin, second:I strip applied perpendicular to Y one on mid cervical region 32 Active-Treatment of Control Group
Control Group postural correction exercises twice a week 4 weeks patients performed scapular and cervical retraction exercises for 10 seconds 31 Active-Treatment of Control Group
ELIGIBILITY CRITERIA
List inclusion criteria List exclusion criteria Age Category Minimum age Maximum age Gender
score above 15 in the neck disability index (NDI) cervical lordotic curve less than 34 fracture, osteoporosis, any symptom of vertebrobasilar insufficiency, diagnosis of cervical radiculopathy myelopathy, fibromyalgia, cervical disc problems syndrome, any tape allergy 20 Year(s) 35 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 04/03/2014 ethics committee of faculty of physical therapy, cairo university
Ethics Committee Address
Street address City Postal code Country
7 ahmed elzayat street, doki cairo 12262 Egypt
OUTCOMES
Type of outcome Outcome Timepoint(s) at which outcome measured
Primary Outcome neck pain intensity pre treatment; on the same day of first intervention post treatment; one day after the last intervention
Secondary Outcome functional neck disability pre treatment; on the same day of first intervention post treatment; one day after the last treatment session
Secondary Outcome cervical curve pre treatment; on the same day of first intervention post treatment; one day after the last treatment session
RECRUITMENT CENTRES
Name of recruitment centre Street address City Postal code Country
out patient clinic of faculty of physical therapy, cairo university 7 Ahmed elzayat sreet cairo 12262 Egypt
FUNDING SOURCES
Name of source Street address City Postal code Country
Aliaa M Elabd 6 sabri abo allam street, shebein elkom 2234915 Egypt
SPONSORS
Sponsor level Name Street address City Postal code Country Nature of sponsor
Primary Sponsor faculty of physical therapy, cairo university 7 ahmed elzayat street, doki cairo 12262 Egypt University
COLLABORATORS
Name Street address City Postal code Country
dr olfat ibrahim 5 anwar elsadat street cairo 12662 Egypt
CONTACT PEOPLE
Role Name Email Phone Street address
Principal Investigator aliaa elabd aliaelabd88@gmail.com 00201069352446 6 Sabri Abo Allam street
City Postal code Country Position/Affiliation
Shebin Elkoum 2234915 Egypt Post graduate researcher, Faculty of Physical Therapy, Univ Cairo
Role Name Email Phone Street address
Public Enquiries haytham elhafez elhafez@yahoo.com 00201001499661 5 Anwar Street
City Postal code Country Position/Affiliation
6th October 16675 Egypt Prof Basic Science Dept, Faulty of Physical Therapy, Univ Cairo
Role Name Email Phone Street address
Scientific Enquiries abeer ibrahim abeerramadan@hotmail.com 00201223819707 Univ Cairo
City Postal code Country Position/Affiliation
Shebin Elkoum 2234915 Egypt Faculty of Physical Therapy, Univ Cairo
REPORTING
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