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.: PACTR202211651838599 Date of Approval: 03/11/2022
Trial Status: Registered in accordance with WHO and ICMJE standards
TRIAL DESCRIPTION
Public title Effect of maitland mobilization versus deep cervical flexors muscles training on chronic mechanical neck pain: A randomized controlled study
Official scientific title Effect of maitland mobilization versus deep cervical flexors muscles training on chronic mechanical neck pain: A randomized controlled study
Brief summary describing the background and objectives of the trial As there growing evidence that buckling and unwanted rotary inter-segmental motion, which can result from the contraction of large multi-segmental muscles during daily tasks, is dependent on precise control of the deeper muscles therefore: the aim of this study is to compare between the effect of cervical Maitland mobilization and deep cervical flexors training to traditional treatment on pain, cervical proprioception, C0-C2 angle and craniovertebral angle on patients with chronic mechanical neck pain.
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 06/11/2022
Actual trial start date
Anticipated date of last follow up 04/06/2023
Actual Last follow-up date
Anticipated target sample size (number of participants) 60
Actual target sample size (number of participants) 60
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 Sealed opaque envelopes Masking/blinding used Outcome Assessors
Parallel: different groups receive different interventions at same time during study Randomised Permuted block randomization Sealed opaque envelopes Masking/blinding used Outcome Assessors
INTERVENTIONS
Intervention type Intervention name Dose Duration Intervention description Group size Nature of control
Experimental Group maitland mobilization 3 times per week at totally 12 sessions successive 4 weeks maitland mobilization (central anteroposterior, unilateral anteroposterior and tranversal vertebral pressure) grade II and grade III 2-3 glides per sec for 30 second effect in chronic mechanical neck on pain ,crainovertebral angle, C0-C2 angle and neck proprioception for totally 12 sessions 20
Control Group estabilished mechanical neck treatment 3 times per week at totally 12 sessions successive 4 weeks a program of mechanical neck treatment based on published review contains 5 repetitions and 20 second hold each stretching upper trapezius, levator scapulae and pectoralis muscles and two sets of 10 repetitions strengthening rhomboids, lower trapezius and serratus anterior muscles 20 Active-Treatment of Control Group
Experimental Group deep cervical flexors training 3 times per week at totally 12 sessions successive 4 weeks deep cervical flexors training from crocklying for less than 10 minutes including rest time, quadribed for 3 minutes rest time including and standing positions for 10 minutes including rest time effect in chronic mechanical neck pain on pain , crainovertebral angle, C0-C2 angle and neck proprioception for totally 12 sessions 20
ELIGIBILITY CRITERIA
List inclusion criteria List exclusion criteria Age Category Minimum age Maximum age Gender
1. Sixty patients diagnosed with mechanical neck pain with no pathologic disease based on the physician diagnosis and referral. 2. Subjects will be from both genders. 3. Age ranges from 18-45 years. 4. Neck pain for at least 3 months . 5. Cranio-vertebral angle (CVA) less than 50 degree . 6. C0-C2 angle is more than 20 degrees . 1. Pathology in cervical that could cause pain such as cervical spondylosis, cervical spondylolisthesis, cervical disc with radiculopathy or any known case of cervical spine canal stenosis. 2. Previous history of malignancy. 3. History of whiplash injury, within 6 weeks of examination. 4. Patients diagnosed with, cervicogenic headache and vertigo. 5. Exposure to acute trauma. 6. Having history of inflammatory joint, muscle disease or infection. 7. Exhibiting inadequate cooperation. 8. Having a diagnosis of cervical myelopathy. 9. History of fractures or surgery of cervical joints affecting within the last 6 months. 10. Presence of cardiopulmonary, hormonal disorder, central neurological disorder or any condition that can influence the results. Adult: 19 Year-44 Year 18 Year(s) 45 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 02/08/2022 faculty of physical therapy cairo university research ethical comittee
Ethics Committee Address
Street address City Postal code Country
7 ahmed elzyat street, been el-saryat, dokki, Giza, Egypt Giza 12613 Egypt
OUTCOMES
Type of outcome Outcome Timepoint(s) at which outcome measured
Primary Outcome cranio-vertebral angle before and after intervention
Primary Outcome C0-C2 angle before and after intervention
Primary Outcome pain before and after intervention
Secondary Outcome neck proprioception before and after intervention
RECRUITMENT CENTRES
Name of recruitment centre Street address City Postal code Country
faculty of physical therapy suez university suez-cairo road , elsalam , suez city suez 41522 Egypt
FUNDING SOURCES
Name of source Street address City Postal code Country
ban saleh 22 mohammed ameer street, el materya, cairo, egypt cairo Egypt
nabil mahmoud 7 ahmed elzyat street, been el-saryat, el dokki, Giza, Egypt Giza Egypt
fatma sedeek 7 ahmed elzyat street, been el-saryat, el dokki, giza , egypt Giza Egypt
SPONSORS
Sponsor level Name Street address City Postal code Country Nature of sponsor
Primary Sponsor ban saleh 22 mohammed ammer street, el materya, cairo, egypt cairo Egypt Individual
Primary Sponsor nabil mahmoud 7 ahmed elzyat street, been el-saryat, el dokki, giza, egypt Giza Egypt Individual
COLLABORATORS
Name Street address City Postal code Country
nabil mahmoud 7 ahmed elzyat, been elsaryat, el dokki, giza, egypt giza Egypt
CONTACT PEOPLE
Role Name Email Phone Street address
Principal Investigator nabil mahmoud abdel aal nabil.mahmoud@cu.edu.eg 201200133613 7 ahmed el zyat, been el saryat, el dokki
City Postal code Country Position/Affiliation
giza Egypt professor
Role Name Email Phone Street address
Scientific Enquiries fatma sedeek ameen fatma.sedeek@cu.edu.eg 201200133613 7 ahmed elzyat, been elsaryat, el dokki
City Postal code Country Position/Affiliation
giza Egypt professor of physiotherapy cairo university
Role Name Email Phone Street address
Public Enquiries ban saleh el shater bansaleh1@icloud.com 201550281123 22 mohammed ammer street, el materya
City Postal code Country Position/Affiliation
cairo Egypt demonastrator at faculty of physical therapy suez 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) Clinical Study Report begining 9 months and ending 36 months following article publication the study will be published in a scientific journal
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