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.: PACTR202001862833093 Date of Approval: 14/01/2020
Trial Status: Registered in accordance with WHO and ICMJE standards
TRIAL DESCRIPTION
Public title Efficacy of A multi-modal Approach in Management of Patients with Upper Crossed Syndrome: A randomized Controlled Trial
Official scientific title Efficacy of A multi-modal Approach in Management of Patients with Upper Crossed Syndrome: A randomized Controlled Trial
Brief summary describing the background and objectives of the trial Upper crossed syndrome (UCS) is a combination of a forward head posture (FHP) and forward shoulder posture (FSP) associated with cervical hyperlordosis, thoracic hyperkyphosis, protraction and elevation of both shoulders and internal rotation, abduction and winging of the scapulae. UCS represents an important health problem in many industrialized countries and is considered as one of the work related musculoskeletal disorders as it leads to a large number of days lost and it’s related workers compensation and disability payments. The technological advancement and popularization of computers and jobs that compel subjects to lean forward or assume a slouched posture for prolonged period of time are the causes UCS. UCS might lead to multitude of dysfunctions all over the body. So finding an effective treatment for UCS is very important. There is a lack of well-designed randomized controlled trails to investigate the efficacy of rehabilitation of UCS. Thus, to date the ideal manual physical therapy approach to treat UCS has not been identified. So the objective of this study is to investigate the efficacy of a multi-modal approach which includes a combination of MET, cervical and scapulothoracic stabilization exercises and postural correction training with advice on patients with UCS. A pilot study will be conducted to calculate sample size. The subjects of both genders with age ranging from 30 to 60 will be allocated randomly into two equal groups A & B. Outcome measures will include: Craniovertebral angle (CVA) and Sagittal shoulder angle (SSA) will be measured by photogrammetry, Pain intensity will be measured by Visual analogue scale (VAS) and functional status will be measured by Neck disability index (NDI) will be done before and after treatment.
Type of trial RCT
Acronym (If the trial has an acronym then please provide) UCS FHP FSP MET CVA SSA VAS NDI
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 20/12/2019
Actual trial start date
Anticipated date of last follow up 01/03/2020
Actual Last follow-up date
Anticipated target sample size (number of participants) 40
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
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 Masking/blinding used Care giver/Provider,Outcome Assessors,Participants
INTERVENTIONS
Intervention type Intervention name Dose Duration Intervention description Group size Nature of control
Experimental Group Group A multimodal approach group three sessions per week four weeks MET, cervical and scapulothoracic stabilization exercises and postural correction training with advice 20
Control Group Group B muscle energy technique group three sessions per week four weeks MET only 20 Active-Treatment of Control Group
ELIGIBILITY CRITERIA
List inclusion criteria List exclusion criteria Age Category Minimum age Maximum age Gender
1. Age ranging from 30 to 60 years old. 2. Male and female. 3. subjects who have weakness in deep neck flexors, serratus anterior, middle and lower trapezius and rhomboid muscles and tightness in upper trapezius, levator scapulae, scallenii, posterior neck and subocciptal muscles, pectoralis major and minor and sternocleidomastoid muscles according to the specialized tests that will be conducted. 4. Subjects complaining of this syndrome for more than 3 months. 5. All participants who will be conscious and cooperative. 6. Subjects who are not receiving medications. 1. BMI more than 40. 2. age older than 60 or younger than 30 years. 3. History of congenital deformity or surgery in spine or shoulder. 4. Participants will be excluded if their cervical and shoulder angles will be ≥48°and ≥52°, respectively as above these values are considered normal. 5. Recent cervical whiplash injury and recent spinal fracture. 6. Osteoporotic subjects and compressive fractures caused by osteoporosis. 7. Marked limitation in shoulder ROM. 8. Leg length discrepancy and functional or structural scoliosis. 9. visual deficits and balance disorders. 10. Pregnancy and subjects with sever comorbid diseases. 11. psychosocial problem and cognitive impairment or inability to understand the scale. 12. Systemic inflammatory diseases. 13. Spinal Tumor and stenosis. Adult: 19 Year-44 Year,Middle Aged: 45 Year(s)-64 Year(s) 30 Year(s) 60 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
No 04/12/2019 faculty of physical therapy research ethics
Ethics Committee Address
Street address City Postal code Country
7 Ahmed El- Zayat Giza 12613 Egypt
OUTCOMES
Type of outcome Outcome Timepoint(s) at which outcome measured
Primary Outcome craniovertebral angle CVA pre and post treatment
Primary Outcome Sagittal shoulder angle SSA pre and post treatment
Secondary Outcome Pain intensity pre and post treatment
Secondary Outcome Functional status pre and post treatment
RECRUITMENT CENTRES
Name of recruitment centre Street address City Postal code Country
faculty of physical therapy cairo university 7 Ahmed El- zayat Giza 12613 Egypt
FUNDING SOURCES
Name of source Street address City Postal code Country
noha mohamed khairy 7 Ahmed El-Zayat Giza 12613 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 Giza 12613 Egypt University
COLLABORATORS
Name Street address City Postal code Country
Dr abd elrahman ahmed elganainy 7 Ahmed El- Zayat Giza 12613 Egypt
CONTACT PEOPLE
Role Name Email Phone Street address
Principal Investigator Noha mohamed Elbadrawy skyn313181@gmail.com +2001141707647 7 Ahmed El- zayat
City Postal code Country Position/Affiliation
Giza 12613 Egypt physical therapist
Role Name Email Phone Street address
Public Enquiries hanaa Kenawy Atta h_k90girl@yahoo.com +2001008320656 7 Ahmed El- Zayat
City Postal code Country Position/Affiliation
Giza 12613 Egypt Lecturer of Basic Science Department Faculty of Physical Therapy Cairo University
Role Name Email Phone Street address
Scientific Enquiries Yasser Aneis dryassercom@yahoo.com +2001011228823 7 Ahmed El- Zayat
City Postal code Country Position/Affiliation
Giza 12613 Egypt Assistant professor of Basic Science Department Faculty of Physical Therapy Cairo University
REPORTING
Share IPD Description Additional Document Types Sharing Time Frame Key Access Criteria
Yes Individual participant data that underlie the results reported in the article after deidentification (text, tables, figures and appendices) Clinical Study Report,Informed Consent Form,Study Protocol Begginning 3 months and ending 5 years following article publication Anyone who wishes to access the data for any purpose
URL Results Available Results Summary Result Posting Date First Journal Publication Date
https://ipd.websites.co.in/update/ipd-sharing-information/200564 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