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.: PACTR202402721993906 Date of Approval: 22/02/2024
Trial Status: Retrospective registration - This trial was registered after enrolment of the first participant
TRIAL DESCRIPTION
Public title Impact of adding the manual diaphragm release technique to traditional neck exercises in adolescents with forward head posture: a randomized controlled trial
Official scientific title Impact of adding the manual diaphragm release technique to traditional neck exercises in adolescents with forward head posture: a randomized controlled trial
Brief summary describing the background and objectives of the trial One of the most overspread postural abnormalities is forward head posture (FHP ) and it is described as head projection anteriorly in relation to the trunk which appears mainly in sagittal plane. Scapular stabilization exercise (SS E) is capable of restoring each of thoracic cage and head neutral optimum position by neck and shoulder muscles interactions and through controlling scapular position and movement Objective: This study was conducted to investigate the impact of adding manual diaphragm release technique to traditional neck exercises in adolescents with forward head posture.
Type of trial RCT
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 Rehabilitation
Anticipated trial start date 01/06/2023
Actual trial start date 01/06/2023
Anticipated date of last follow up 01/10/2023
Actual Last follow-up date
Anticipated target sample size (number of participants) 120
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 Numbered containers 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 Traditional neck exercises 3 times per week for 3 months Strengthen Deep Cervical Flexors: Lying chin tuck. Lying chin tuck with head lift (4 s). 3 sets of 12 repetitions 3 sets of 12 repetitions Strengthen Shoulder Retractors: Standing shoulder pull back with elastic Resistance. shoulder pull back with weight (2 lb.) 3 sets of 12 repetitions 3 sets of 12 repetitions Stretch Cervical Extensors: Chin drop 3 repetitions with 30-sec hold Stretch Pectoralis Muscle: Bilateral Pectoral stretch 3 repetitions with 30-sec hold 60 Active-Treatment of Control Group
Experimental Group Manual diaphragm release technique in addition to traditional neck exercises Once a week 3 months Manual diaphragm release: The patient was positioned in the supine position. The therapist stood at the head of the patient. The therapist made manual contact bilaterally under the costal cartilages of the lower ribs (7th to 10th ) with hypothenar regions of the hands and last three fingers. During the patient’s inspiration, the therapist was gently pulling the points of hands contacts toward the head and slightly laterally, while elevating the ribs simultaneously. During exhalation, the therapist deepened hand contacts towards the inner costal margins. The release technique was performed once a week for three months; each technique lasted for 5 to 7 minutes. All release techniques were done by the same physiotherapist. 60
ELIGIBILITY CRITERIA
List inclusion criteria List exclusion criteria Age Category Minimum age Maximum age Gender
– Male students their age ranged from 17 to 18 years. – Had Body Mass Index (BMI) = 5th percentile to less than the 85th percentile. – Studying at any faculty at Pharos University in Alexandria. – Cooperative and followed the instructions. – Subjects were excluded from the study if the student had visual or hearing defects. – Overweight, obese or cachexic students. – Had any neurological disorders. – Had musculoskeletal problems. – Had any congenital abnormalities that might affect the study. Adolescent: 13 Year-18 Year 17 Year(s) 18 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
Yes 28/05/2023 Unit of Research Approval Committee UREAC
Ethics Committee Address
Street address City Postal code Country
Canal El Mahmoudia Street, beside Green Plaza Complex, Alexandria, Egypt Alexandria 21648 Egypt
OUTCOMES
Type of outcome Outcome Timepoint(s) at which outcome measured
Primary Outcome Body Angles (Degrees) and Distances (Centimeters) Assessed Using the Postural assessment software PAS/SAPO from right and left lateral views 1-Horizontal head alignment, lateral view HHA-lateral- Angle between right tragus, C7 and horizontal. 2-Vertical head alignment VHA- Angle between right tragus, right acromion and vertical. Pre and post intervention
Secondary Outcome Body Angles (Degrees) and Distances Assessed Using the PAS/SAPO from Anterior view. 1-Horizontal head alignment, anterior view. HHA- Anterior- Angle between tragus of ear and horizontal. 2-Horizontal alignment of acromions. HAA- Angle between both acromions and horizontal. Body Angles (Degrees) Assessed Using the PAS/SAPO from posterior view.3- Horizontal asymmetry of scapula in relation to T3.HAST3- Horizontal asymmetry of scapula in relation to T3 Pre and post treatment
RECRUITMENT CENTRES
Name of recruitment centre Street address City Postal code Country
Pharos University in Alexandria Canal El Mahmoudia Street, beside Green Plaza Complex. Alexandria Egypt
FUNDING SOURCES
Name of source Street address City Postal code Country
No funding sources - Alexandria Egypt
SPONSORS
Sponsor level Name Street address City Postal code Country Nature of sponsor
Secondary Sponsor No sponsers - Alexandria Egypt No sponsers
COLLABORATORS
Name Street address City Postal code Country
CONTACT PEOPLE
Role Name Email Phone Street address
Principal Investigator Amal Youssef Wahba amal.youssef@pua.edu.eg +201002472964 Canal El Mahmoudia Street, beside Green Plaza Complex.
City Postal code Country Position/Affiliation
Alexandria Egypt Lecturer at Faculty of Physical Therapy Pharos University in Alexandria
Role Name Email Phone Street address
Public Enquiries Ola Elgohary ola.elgohary@pua.edu.eg +201227191398 Canal El Mahmoudia Street, beside Green Plaza Complex.
City Postal code Country Position/Affiliation
Alexandria Egypt Lecturer
Role Name Email Phone Street address
Scientific Enquiries Mai Abdelkader mai.abdelkader@pua.edu.eg +201094355573 Canal El Mahmoudia Street, beside Green Plaza Complex.
City Postal code Country Position/Affiliation
Alexandria Egypt Lecturer
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). Informed Consent Form,Statistical Analysis Plan,Study Protocol Beginning 3 months and ending 5 years following article publication Data are available indefinitely at (Link to be included)
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