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.: PACTR202102867579609 Date of Approval: 09/02/2021
Trial Status: Registered in accordance with WHO and ICMJE standards
TRIAL DESCRIPTION
Public title Intermittent versus Continuous Traction in Management of Mechanical Neck Dysfunction
Official scientific title Intermittent versus Continuous Traction in Management of Mechanical Neck Dysfunction
Brief summary describing the background and objectives of the trial Intermittent or Continuous Traction has a better effect on neck pain intensity, cervical ROM and neck disability in patients with mechanical neck dysfunction
Type of trial RCT
Acronym (If the trial has an acronym then please provide)
Disease(s) or condition(s) being studied Musculoskeletal Diseases,Nervous System Diseases,Orthopaedics
Sub-Disease(s) or condition(s) being studied
Purpose of the trial Treatment: Other
Anticipated trial start date 28/02/2021
Actual trial start date 01/03/2021
Anticipated date of last follow up 01/06/2021
Actual Last follow-up date
Anticipated target sample size (number of participants) 45
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
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
INTERVENTIONS
Intervention type Intervention name Dose Duration Intervention description Group size Nature of control
Control Group traditional physical therapy program 3 sessions per week for a period of 4 weeks 3 sessions per week for a period of 4 weeks traditional physical therapy program (IR and Exercise in form of a-stretching of the upper trapezius, sternocleidomastoid, levator scapula, and scaleni. b- Isometric neck exercise) 15 Active-Treatment of Control Group
Experimental Group intermittent traction 3 sessions per week for 4 weeks 3 sessions per week for 4 weeks intermittent traction in addition to the traditional physical therapy program. 15
Experimental Group continuous traction 3 sessions per week every other day for one month 3 sessions per week every other day for one month continuous traction in addition to the traditional physical therapy program. 15
ELIGIBILITY CRITERIA
List inclusion criteria List exclusion criteria Age Category Minimum age Maximum age Gender
1. Forty-five patients of both sexes with ages ranged from 20-40 years. 2. Referred from orthopedic consultants with mechanical neck dysfunction. 3. The neck disability index (NDI) is above 5 4. Patients will be able to perform a (ROM) test of the cervical spine. 1. Neck pain that was not of mechanical origin. 2. History of previous neck trauma or head injuries 3. Ankylosing spondylitis 4. Osteoporosis 5. Cervical rib syndrome 6. Post-surgical neck conditions 7. Open wound over the cervical region 8. Internal fixation of cervical vertebrae 9. Cerebrovascular abnormalities 10. Visual or auditory problems 11. rheumatic arthritis 12. Inability to tolerate cervical flexion position Adult: 19 Year-44 Year 20 Year(s) 40 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 10/08/2020 Faculty of physical therapy Cairo university
Ethics Committee Address
Street address City Postal code Country
7 ahmed elziat st. bein srayyat giza ,Egypt Cairo 11411 Egypt
OUTCOMES
Type of outcome Outcome Timepoint(s) at which outcome measured
Primary Outcome neck pain intensity by visual analogue scale (VAS): before and after the intervention
Primary Outcome cervical Range Of Motion by Bubble inclinometers before and after intervention
Secondary Outcome neck disability by Neck Disability Index (NDI) before and after intervention
RECRUITMENT CENTRES
Name of recruitment centre Street address City Postal code Country
physical therapy department of Derb Nigm general hospital 22 derb nigm street Al Sharqia Al Sharqia 11511 Egypt
FUNDING SOURCES
Name of source Street address City Postal code Country
Mohamed Mostafa 7 ahmed elziat st. bein srayyat giza ,Egypt Cairo 11411 Egypt
SPONSORS
Sponsor level Name Street address City Postal code Country Nature of sponsor
Primary Sponsor physical therapy department of Derb Nigm general hospital 22 Derb Nigm street Al Sharqia 11511 Egypt Hospital
COLLABORATORS
Name Street address City Postal code Country
CONTACT PEOPLE
Role Name Email Phone Street address
Principal Investigator Mohamed Mostafa drsergany_79@hotmail.com 00201140974442 77 shalhoub street ahmed essmat ain shams
City Postal code Country Position/Affiliation
Cairo 11311 Egypt Associate professor department of basic science faculty of physical therapy Cairo university and Heliopolis university
Role Name Email Phone Street address
Public Enquiries Tamer Ali drtamerthabet@gmail.com 00201097741455 28 mahmoud azzam st
City Postal code Country Position/Affiliation
Al Sharqia 11511 Egypt physiotherapist specialist at Derb Nigm general hospital
Role Name Email Phone Street address
Scientific Enquiries Mohamed Mostafa drsergany_79@hotmail.com 00201140974442 77 shalhoub street ain shams
City Postal code Country Position/Affiliation
Cairo Egypt Associate Professor Basic Sciences Department Faculty of Physical Therapy Cairo University and Heliopolis 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) Statistical Analysis Plan,Study Protocol 12 months period time after publication Controlling access to 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