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.: PACTR202305496961094 Date of Approval: 09/05/2023
Trial Status: Retrospective registration - This trial was registered after enrolment of the first participant
TRIAL DESCRIPTION
Public title The Effect of neck muscles exercise program on biomechanical head alignment, neck pain and disability among Alexandria faculty of Nursing Students’.
Official scientific title The Effect of neck muscles exercise program on biomechanical head alignment, neck pain and disability among Alexandria faculty of Nursing Students’.
Brief summary describing the background and objectives of the trial The forward head posture causes extension of the cervical vertebra. It results in shortening of the sternocleidomastoid muscle, posterior cervical extension muscles, and upper trapezius. Moreover, weakening of the anterior cervical vertebra muscle that increase the incidence of cervical disc prolapse. According to the nature of the nursing student’s work and using computer for long time thus, one of the important findings of the current study that reduction of neck pain among nursing students using neck muscle strengthening which can be directly has an effect on the reaming region of the vertebral column. The aim of the present study is to determine the effect of neck muscled exercises on head alignment besides to evaluate the degree of neck pain and disability index among Alexandria faculty of Nursing Students’.
Type of trial RCT
Acronym (If the trial has an acronym then please provide)
Disease(s) or condition(s) being studied Orthopaedics
Sub-Disease(s) or condition(s) being studied
Purpose of the trial Rehabilitation
Anticipated trial start date 01/01/2023
Actual trial start date 05/01/2023
Anticipated date of last follow up 28/02/2023
Actual Last follow-up date 27/02/2023
Anticipated target sample size (number of participants) 50
Actual target sample size (number of participants)
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 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 Neck muscles Exercise Program Neck muscles Exercise Program will be done 10 repetition for 10 seconds hold, three sessions per week, for up to four successive weeks. four weeks. ● Neck muscles Exercise Program demonstrated as follows: 1-Stretching neck flexors muscle: 2- Manual strengthening neck extensors 3- Self -strengthening for flexor muscles ● All participants will be evaluated four times in four different occasions; before implementation of the neck muscle exercises program, immediately after the end of the last neck muscle exercises session. ● Data will be analyzed using appropriate statistical analysis to evaluate the effectiveness of application of neck muscles exercise program by comparing the assessment data that will be obtained at four points of time. 25
Control Group Home based program three sessions per week, for up to four successive weeks Four weeks. General home neck flexion, rotation, side bending and extension. It will be done in front of mirror for visual feed back. 25 Placebo
ELIGIBILITY CRITERIA
List inclusion criteria List exclusion criteria Age Category Minimum age Maximum age Gender
1- Age (18-25 years old) 2- Weight (ranging from 60 – 85 kg) 3- Height (ranging from155 – 175 cm) 4- Sex (male / female) 1- Cervical disc prolapse 2- Cervical radiculopathy with referred pain 3- History of neck surgery or trauma. Adult: 19 Year-44 Year 19 Year(s) 22 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 17/07/2022 Research Ethical Committe Faculty of Nursing.
Ethics Committee Address
Street address City Postal code Country
Al Rahma Street. Alexandria. 21500 Egypt
OUTCOMES
Type of outcome Outcome Timepoint(s) at which outcome measured
Primary Outcome Determine effect of neck muscle exercise program on biomechanical head alignment, neck pain, and disability among Alexandria faculty of nursing students’. Four weeks.
Secondary Outcome The Neck Disability Index (NDI) will be adopted to assess disability associated with neck pain among the students. It is used to determine the effect of neck exercise to improve the alignment of the head and decrease the percentage of this index. Four weeks.
RECRUITMENT CENTRES
Name of recruitment centre Street address City Postal code Country
Faculty of Nursing Al Rahma Street Alexandria 21617 Egypt
FUNDING SOURCES
Name of source Street address City Postal code Country
Principal Investigator alqaet SAKAKA 2014 Saudi Arabia
SPONSORS
Sponsor level Name Street address City Postal code Country Nature of sponsor
Primary Sponsor Alexandria University Al Rahma Street Alexandria. 21500 Egypt University
COLLABORATORS
Name Street address City Postal code Country
CONTACT PEOPLE
Role Name Email Phone Street address
Principal Investigator Amany AbdEltawab aeabdullah@ju.edu.sa 00960541806736 Allaqauet.
City Postal code Country Position/Affiliation
alqaet 2014 Saudi Arabia Physical Therapy and Health Rehabilitation Department Faculty of Applied Medical Sciences Jouf University Biomechanics Department Faculty of Physical Therapy Cairo Univ
Role Name Email Phone Street address
Scientific Enquiries Dalia ELSHERBINI dmelsherbini@ju.edu.sa 00966594488624 Alqaet
City Postal code Country Position/Affiliation
Sakaka 21400 Saudi Arabia Department of Clinical Laboratory Sciences College of Applied Medical Sciences Jouf University
Role Name Email Phone Street address
Public Enquiries Jehan Elrazkey jehanelrazky123@gmail.com 00201204430996 Alexandria street
City Postal code Country Position/Affiliation
Alexandria 21500 Egypt faculty of nursing department of surgery Alexandria university
REPORTING
Share IPD Description Additional Document Types Sharing Time Frame Key Access Criteria
Yes Individual participant data that underlie the results reported in this article, after deidentification (text, tables, figures, and appendices). Study Protocol is the document was available. the data will be available from the beginning 3 months and ending 5 years following article publication. Researchers who provide a methodologically sound proposal. the type of analyses in order to achieve aims in the approved proposal. Proposal may be submitted up to 36 months following article publication. Study Protocol Proposal may be submitted up to 36 months following article publication. GraphPad Prism version 9 was used to analyze collected data, which presented as mean± SEM. The difference in demographic characteristics among two groups was detected by student’s t-test. While to assess outcome variables between the two groups, we used Two-way repeated measures ANOVA. The effect size between-group effect was calculated by partial eta square. Significance was considered when p<0.05. The paired t-test was performed to test the outcome difference within each group. Using a linear regression model with a generalized estimating equations (GEE) correction.
URL Results Available Results Summary Result Posting Date First Journal Publication Date
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