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.: PACTR201508001224275 Date of Approval: 04/08/2015
Trial Status: Retrospective registration - This trial was registered after enrolment of the first participant
TRIAL DESCRIPTION
Public title kinesio taping and postural correction exercises for neck pain
Official scientific title Cervical Kinesio Taping and Postural Correction Exercises Influence Clinical and Electromyographic Characteristics in Mechanical Neck Dysfunction Patients: A Randomized Blinded Clinical Trial
Brief summary describing the background and objectives of the trial Background/ Aim: Mechanical neck dysfunction (MND) with sustained trapezius muscle activities is common with poor prognosis. Kinesio taping (KT) is a new therapeutic modality to correct and treat many musculoskeletal disorders. Postural correction is a common treatment approach including repetitions of cervical and scapular retraction. Combined treatments have better effects for neck pain. So, we aimed to determine the effect of kinesio taping and postural correction exercises on neck pain level, neck diability, electromyographic characteristics of upper trapezius (UT).
Type of trial RCT
Acronym (If the trial has an acronym then please provide)
Disease(s) or condition(s) being studied mechanical cervical dysfunction,Musculoskeletal Diseases
Sub-Disease(s) or condition(s) being studied
Purpose of the trial Physical activity and nutrition
Anticipated trial start date 05/10/2014
Actual trial start date 15/10/2014
Anticipated date of last follow up 06/04/2015
Actual Last follow-up date 10/04/2015
Anticipated target sample size (number of participants) 90
Actual target sample size (number of participants) 94
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 cervical kinesio taping 2 times per 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 31 Uncontrolled
Control Group postural correction exercises 2 times per week 4 weeks patients performed scapular and cervical retraction exercises for 10 seconds 31 Active-Treatment of Control Group
Experimental Group kinesio taping with postural correction exercises 2 times per week 4 weeks patients performed scapular and cervical retraction exercises for 10 seconds with kinesio tape applied on their cervical muscles 32 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 had a history of neck pain of greater than three months duration diagnosed by orthopedist with mechanical neck dysfunction 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 pain intensity pre treatment on the same day of the first intervention. post treatment. on the second day after the last intervention
Secondary Outcome neck disability pre treatment; on the same day prior to first intervention post treatment; on the second day following the last intervention
Secondary Outcome upper trapezius electromyographic activities pre treatment; on the same day prior to the first intervention post treatment; on the second day following the last intervention
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 haytham elhafez 5 anwar elsadat street 6 october 12662 Egypt University
Primary Sponsor faculty of physical therapy, cairo university 7 Ahmed elzayat sreet cairo 12262 Egypt University
COLLABORATORS
Name Street address City Postal code Country
dr olfat ibrahim 5 ahmed maher street cairo 12546 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 Professor, Basic Science Department. Dean of Faculty of Physical Therapy, Pharos University, Egypt
Role Name Email Phone Street address
Public Enquiries Aliaa Elabd aliaelabd88@gmail.com 00201069352446 6 Sabri Abo Allam street
City Postal code Country Position/Affiliation
Shebin Elkoum 2234915 Egypt lecturer, basic science department, faculty of physical therapy, Cairo university, Egypt
Role Name Email Phone Street address
Scientific Enquiries Aliaa Elabd aliaelabd88@gmail.com 00201069352446 6 Sabri Abo Allam Street
City Postal code Country Position/Affiliation
Shebin Elkoum 2234915 Egypt Professor, basic science department, faculty of physical therapy, Cairo University, Egypt.
REPORTING
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