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.: PACTR202005710448178 Date of Approval: 25/05/2020
Trial Status: Retrospective registration - This trial was registered after enrolment of the first participant
TRIAL DESCRIPTION
Public title Sustained Natural Apophyseal Glide versus Myofascial Release on Respiratory Muscles Activity in Forward Head Posture
Official scientific title Sustained Natural Apophyseal Glide versus Myofascial Release on Respiratory Muscles Activity in Forward Head Posture
Brief summary describing the background and objectives of the trial The purpose will be to investigate if there any difference between sustained natural apophyseal glide technique and myofascial release on respiratory muscles electromyography response?.
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 Treatment: Other
Anticipated trial start date 01/06/2019
Actual trial start date 01/06/2019
Anticipated date of last follow up 01/01/2020
Actual Last follow-up date
Anticipated target sample size (number of participants) 40
Actual target sample size (number of participants) 40
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 by using procedures such as coin-tossing or dice-rolling Allocation was determined by the holder of the sequence who is situated off site Masking/blinding used Participants
INTERVENTIONS
Intervention type Intervention name Dose Duration Intervention description Group size Nature of control
Experimental Group SUSTAINED NATURAL APOPHYSEAL GLIDE ON RESPIRATORY MUSCLES ACTIVITY IN FORWARD HEAD POSTURE 3 SESSIONS PER WEEK MONTH SUSTAINED NATURAL APOPHYSEAL GLIDE ON RESPIRATORY MUSCLES ACTIVITY IN FORWARD HEAD POSTURE 20
Control Group MYOFASCIAL RELEASE ON RESPIRATORY MUSCLES ACTIVITY 3 SESSIONS PER WEEK MONTH MYOFASCIAL RELEASE ON RESPIRATORY MUSCLES ACTIVITY 20 Active-Treatment of Control Group
ELIGIBILITY CRITERIA
List inclusion criteria List exclusion criteria Age Category Minimum age Maximum age Gender
1- Forward head posture. 2-Chronic neck patient is defined as neck pain with duration of more than 3 Months(Medina-Mirapeix et al., 2009) 3-Inculde male and female patients 4-Patients age ≥30 up to 50 years 5- Nonspecific neck pain 6- patients with cervical spondylosis 1-Patients with any chest diseases 2-Smoker patients 3-Patients with heart failure 4- Patients with neurological disease affecting respiratory muscles or any muscular dystrophies 5-Patients with previous cervical or thoracic surgery 6- Patients that are unable to rate their neck pain on Numeric Rating scale (NRS) 7-Those with any musculoskeletal abnormalities as kyphosis, scoliosis and kyphoscoliosis Adult: 19 Year-44 Year,Middle Aged: 45 Year(s)-64 Year(s) 30 Year(s) 50 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 09/10/2018 faculty of physical therapy cairo university
Ethics Committee Address
Street address City Postal code Country
ahmed elzayat st. giza 12511 Egypt
OUTCOMES
Type of outcome Outcome Timepoint(s) at which outcome measured
Primary Outcome e.m.g of respiratory muscles before and after treatment pre and post completion of study
Secondary Outcome pain and posture pre and post completion of study
RECRUITMENT CENTRES
Name of recruitment centre Street address City Postal code Country
faculty of physical therapy cairo university 7 ahmed elzayat street , dokki , giza , egypt giza Egypt
FUNDING SOURCES
Name of source Street address City Postal code Country
ahmed mohamed mekhemar omran adel elharmel st. tanta Egypt
SPONSORS
Sponsor level Name Street address City Postal code Country Nature of sponsor
Primary Sponsor faculty of physical therapy cairo university 7 ahmed el-zayat street , dokki , giza giza Egypt University
COLLABORATORS
Name Street address City Postal code Country
hala ezz eldin 7 ahmed elzayat , dokki , giza , egypt giza Egypt
CONTACT PEOPLE
Role Name Email Phone Street address
Principal Investigator hala ezz eldin dr.a.m.omran@gmail.com 00201006626043 7 ahmed el-zayat street , dokki , giza , egypt
City Postal code Country Position/Affiliation
giza Egypt professor
Role Name Email Phone Street address
Scientific Enquiries hanan hosny hhneurophysio_edu@yahoo.com 00201001464397 7 ahmed el-zayat street , dokki , giza , egypt
City Postal code Country Position/Affiliation
giza Egypt professor
Role Name Email Phone Street address
Principal Investigator abeer ahmed abeer.phth@yahoo.com 00201116013302 7 ahmed el-zayat street , dokki , giza , egypt
City Postal code Country Position/Affiliation
giza Egypt assisstant professor
Role Name Email Phone Street address
Public Enquiries ahmed mohamed mekhemar omran dr.a.m.omran@gmail.com 00201008474644 7 ahmed el-zayat street , dokki , giza , egypt
City Postal code Country Position/Affiliation
giza Egypt p.h.d. student
REPORTING
Share IPD Description Additional Document Types Sharing Time Frame Key Access Criteria
Yes individual participant data that underlying the result reported in this article , after deidentification ( text , tables , figures and appendices ) . Statistical Analysis Plan 12 months following publication anyone who wishes to access the data
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