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.: PACTR201907852069410 Date of Approval: 24/07/2019
Trial Status: Retrospective registration - This trial was registered after enrolment of the first participant
TRIAL DESCRIPTION
Public title Effect of Mulligan Sustained Natural Apophyseal Guides on Respiratory Function in Thoracic Kyphosis
Official scientific title Effect of Mulligan Sustained Natural Apophyseal Guides on Respiratory Function, kyphotic angle in Thoracic Kyphosis
Brief summary describing the background and objectives of the trial The thoracic kyphosis is the primary curve of the vertebral column which is comprised of 12 vertebrae. The thoracic kyphosis angle increases with age and the increase is greater in females than in males .Normal values for the thoracic kyphosis are between 20˚and 45˚.kyphosis can be found in all age groups 30% in teenagers, 35% in adults, and 40% in the elderly. ). An increase in thoracic kyphosis has also been associated with diminished physical function ,impairment of respiratory function.Mulligan mobilization technique can used to improve extension range of motion in the thoracic spine using SNAGS.Thus, the purpose of this study is to determine the effects of the Mulligan SNAG mobilization on respiratory Functions in subjects with thoracic kyphosis.outcome measure would include Forced Vital Capacity(FVC), Forced Expiratory Volume in the 1st second(FEV1), Maximum Voluntary Ventilation(MVV)measured by spirometer chest graph 101 and Kyphotic angle measured by digital x ray, and chest expansion measurd by Wide spreading caliper. the assessment will be done at baseline and after the last treatment session.
Type of trial RCT
Acronym (If the trial has an acronym then please provide) SNAG MVV FVC FEV1
Disease(s) or condition(s) being studied Musculoskeletal Diseases,Respiratory
Sub-Disease(s) or condition(s) being studied
Purpose of the trial Treatment: Other
Anticipated trial start date 20/03/2019
Actual trial start date 01/04/2019
Anticipated date of last follow up 21/07/2019
Actual Last follow-up date 20/08/2019
Anticipated target sample size (number of participants) 40
Actual target sample size (number of participants) 40
Recruitment status 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
Factorial: participants randomly allocated to either no, one, some or all interventions simultaneously Randomised Simple randomization using a randomization table created by a computer software program Numbered containers Open-label(Masking Not Used)
INTERVENTIONS
Intervention type Intervention name Dose Duration Intervention description Group size Nature of control
Experimental Group Group A 3 Sessions per week 4 weeks will recieve Mulligan SUSTAINED NATURAL APOPHYSEAL GLIDES ( SNAGs) on thoracic spine and posture correction exercise 20
Control Group groupB 3 session per week 4 weeks will receive posture correction exercise on thoracic spine 20 Placebo
ELIGIBILITY CRITERIA
List inclusion criteria List exclusion criteria Age Category Minimum age Maximum age Gender
• All subjects have kyphotic posture and their kyphotic angle greater than normal and have respiratory problem. • The subjects are aged from 18-28 years. • Body mass index are normal 18.5 -24.9 kg/m2. • All subjects are medically stable and not suffer from any other diseases which may affect trail results • Subjects who had undergone operation in the spinal bones or chest. • Subjects has traumatic chest injury. • Subjects has chronic neuromuscular pain not related to other body parts. • Clinical abnormalities in the rib cage and Upper abdominal surgery. • Smoker subjects. • Subjects has obstructive lung disease as COPD. Adolescent: 13 Year-18 Year,Adult: 19 Year-44 Year 18 Year(s) 28 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 03/02/2019 faculty of physical therapy research ethics
Ethics Committee Address
Street address City Postal code Country
7 Ahmed EL Zayad street,Dooki, Giza, Egypt Giza 12613 Egypt
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 03/02/2019 faculty of physical therapy research centers
Ethics Committee Address
Street address City Postal code Country
7 Ahmed EL Zayad street, Giza,Egypt Giza 12613 Egypt
OUTCOMES
Type of outcome Outcome Timepoint(s) at which outcome measured
Primary Outcome Forced Vital Capacity Before treatment and after completion of the itervention
Secondary Outcome Forced Expiratory Volume in the first second Before treatment and after completion of the intervention
Secondary Outcome Maximum Voluntary Ventilation Before treatment and after completion of the intervention
Secondary Outcome Kyphotic Angle Before treatment and after completion of the intervention
RECRUITMENT CENTRES
Name of recruitment centre Street address City Postal code Country
Faculty of physical therapy Cairo university 7 Ahmed El Zayad street, Dooki,Giza, Egypt Giza Egypt
FUNDING SOURCES
Name of source Street address City Postal code Country
Shaimaa Ramadan Abo Zaher-Sherbin El Mansoura 35661 Egypt
SPONSORS
Sponsor level Name Street address City Postal code Country Nature of sponsor
Primary Sponsor Cairo University 1 Gamaa Street,Giza Giza 12613 Egypt University
Primary Sponsor Faculty of physical therapy Cairo University 7 Ahmed EL Zayad street, Dooki Giza 12613 Egypt University
COLLABORATORS
Name Street address City Postal code Country
mohamed hussin el gendy 7 Ahmed EL Zayad street,Dokki Giza 12613 Egypt
Shaimaa Taha 7 Ahmed EL Zayad street,Dokki Giza 12613 Egypt
saher ibrahim 7 El Gomhoria street,Mansoura mansoura Egypt
CONTACT PEOPLE
Role Name Email Phone Street address
Principal Investigator Shaimaa Ramadan dr.shaimaa100@gmail.com 00201010578100 Abozaher,Sherbin, Ad Daqahliyah
City Postal code Country Position/Affiliation
Mansura 35661 Egypt physical therapist
Role Name Email Phone Street address
Public Enquiries mohamed el gendy doaaamin38@yahoo.com 00201005747169 7 Ahmed El Zayad street, Dooki
City Postal code Country Position/Affiliation
Giza Egypt Professor doctor of Physical Therapy Department Of Basic Science Faculty of Physical Therapy Cairo University
Role Name Email Phone Street address
Scientific Enquiries Shaimaa Taha dr.shymaelshazly@yahoo.com 00201229823327 7 Ahmed EL Z ayad street,Dooki
City Postal code Country Position/Affiliation
Giza Egypt Lecturer of Physical Therapy Department Of Basic Science Faculty of Physical Therapy Cairo University
Role Name Email Phone Street address
Scientific Enquiries Saher Ibrahim sahertaman@mans.edu.eg 00201066174882 7 El Gomhoria street,Mansoura
City Postal code Country Position/Affiliation
Mansoura Egypt Lecturer of Diagnostic Radiology Faculty of Medicine Mansoura University
REPORTING
Share IPD Description Additional Document Types Sharing Time Frame Key Access Criteria
Yes All subjects have kyphotic posture and their kyphotic angle greater than normal and have respiratory problem.The subjects are aged from 18-28 years.Body mass index from 18.5 -24.9 kg/m.All subjects are medically stable and not suffer from any other diseases which may affect trail results Study Protocol after 2 months open access
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
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