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.: PACTR202307610793616 Date of Approval: 27/07/2023
Trial Status: Retrospective registration - This trial was registered after enrolment of the first participant
TRIAL DESCRIPTION
Public title Effectiveness of Kinesio Taping versus Mechanical Cervical Traction on Reducing Neck Pain in Young Female University Students
Official scientific title Effectiveness of Kinesio Taping versus Mechanical Cervical Traction on Reducing Neck Pain in Young Female University Students
Brief summary describing the background and objectives of the trial Mechanical neck pain is most common among young female university students that leads to increase disability and depression as well as contribute to sleep disturbance and reduction of physical activity. The aim of the current study is to compare the effect of kinesio taping compared to mechanical cervical traction on young female university students with neck pain.
Type of trial CCT
Acronym (If the trial has an acronym then please provide)
Disease(s) or condition(s) being studied Musculoskeletal Diseases
Sub-Disease(s) or condition(s) being studied
Purpose of the trial Treatment: Devices
Anticipated trial start date 15/08/2022
Actual trial start date
Anticipated date of last follow up 08/10/2022
Actual Last follow-up date
Anticipated target sample size (number of participants) 60
Actual target sample size (number of participants)
Recruitment status Not yet recruiting
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 Non-randomised Allocation was determined by the holder of the sequence who is situated off site Masking/blinding used Care giver/Provider,Outcome Assessors,Participants
INTERVENTIONS
Intervention type Intervention name Dose Duration Intervention description Group size Nature of control
Control Group exercises 3 days 6 weeks each participants will receive 15 minutes Infrared, followed by 15 minutes massage and the starts the strengthening and scratching exercise 20 Active-Treatment of Control Group
Experimental Group Mechanical Cervical traction 3 days per week 6 weeks The position of the patient was supine lying position with the neck of the subject flexed 30- degrees. The head halter applied and fit to the subject comfortably ad attached to the traction unite. The patient aligned for pulling force properly after that the unite of traction activated. The type of traction application is intermittent with the hold time and rest time of 10 sec each. The force of traction was same to all participants. 20
Experimental Group Kinesio taping 2 times per week 6 weeks The application of Y shape kinesio taping parallel to the paraspinal muscles of cervical region for muscle relaxation 20
ELIGIBILITY CRITERIA
List inclusion criteria List exclusion criteria Age Category Minimum age Maximum age Gender
young female university students aged from 19 to 23 years with a history of chronic mechanical neck pain (CMNP) for at least 3 months Participants were excluded if they had clinical recommendation of severe abnormalities or disorders of the cervical spine such as ligamentous injury, joint dislocation or disruption, disk prolapse, cervical stenosis, referred pain, recent surgery or fracture in the cervical region, pregnant women, allergy to kinesio taping. Adult: 19 Year-44 Year 19 Year(s) 23 Year(s) Female
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 02/08/2022 institutional review board of Physical Therapy College Cairo university
Ethics Committee Address
Street address City Postal code Country
7 Ahmed Elziat Street, Ben Elsarayat, El Dokki, Faculty of Physical Therapy, Cairo University, Biomechanics Department, Giza, Egypt. Cairo 12612 Egypt
OUTCOMES
Type of outcome Outcome Timepoint(s) at which outcome measured
Primary Outcome neck pain intensity chronic pain for at least 3 months
Secondary Outcome functional disability at least 3 months
RECRUITMENT CENTRES
Name of recruitment centre Street address City Postal code Country
out clinic of Physical Therapy college Physical Therapy college, Cairo University Cairo Egypt
FUNDING SOURCES
Name of source Street address City Postal code Country
self funded self funded self funded Egypt
SPONSORS
Sponsor level Name Street address City Postal code Country Nature of sponsor
Primary Sponsor self funded self funded self funded Egypt University
COLLABORATORS
Name Street address City Postal code Country
CONTACT PEOPLE
Role Name Email Phone Street address
Principal Investigator Amani Abdeltawab dramanysleem@yahoo.com +201062734100 121 Mahaba st. Fayom, Egypt
City Postal code Country Position/Affiliation
Fayom Egypt Lecturer at Physical Therapy college Cairo University
Role Name Email Phone Street address
Public Enquiries Mariam Ameer Mariam_ameer7@hotmail.com +01061273399 151 Gardenia city, Nacre city, Cairo, Egypt
City Postal code Country Position/Affiliation
Cairo Egypt Assistant professor at Physical Therapy College Cairo University
Role Name Email Phone Street address
Scientific Enquiries Mariam Ameer Mariam_ameer7@hotmail.com +01061273399 151 Gardenia city, Nacre City Cairo Egypt
City Postal code Country Position/Affiliation
Cairo Egypt Assistant professor at Physical Therapy College Cairo University
REPORTING
Share IPD Description Additional Document Types Sharing Time Frame Key Access Criteria
Yes individual participant data will be collected after starting the study. Individual participant data that underlie the results reported in this article, after deidentification will be shared (text, tables, figures, and appendices) Analytic Code,Statistical Analysis Plan,Study Protocol will be available in 12/12/2023 The second author, the parametric analysis of data will be available and can be requested via email at any time required.
URL Results Available Results Summary Result Posting Date First Journal Publication Date
not available No
Result Upload 1: Result Upload 2: Result Upload 3: Result Upload 4: Result Upload 5:
Result URL Hyperlinks Link To Protocol
Result URL Hyperlinks
Changes to trial information