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.: PACTR202204906237759 Date of Approval: 25/04/2022
Trial Status: Registered in accordance with WHO and ICMJE standards
TRIAL DESCRIPTION
Public title Mobilization with movement versus thoracic manipulation on neck proprioceptin in mechanical neck pain: A randomized controlled study
Official scientific title Mobilization with movement versus thoracic manipulation on neck proprioceptin in mechanical neck pain: A randomized controlled study
Brief summary describing the background and objectives of the trial As There is a growing body of evidence that manual therapy directed to the thoracic spine to treat mechanical neck pain therefore: Was there a difference in the effect of adding mulligan SNAGs versus thoracic manipulation to conventional physical therapy program on neck proprioception, pain, suboccipital angel, forward head position and rounded shoulder on patient with 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 Treatment: Other
Anticipated trial start date 27/04/2022
Actual trial start date
Anticipated date of last follow up 31/07/2022
Actual Last follow-up date 31/07/2022
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
INTERVENTIONS
Intervention type Intervention name Dose Duration Intervention description Group size Nature of control
Experimental Group Mobilization with movement to thoracic spine 3 times per week at totally 12 sessions successive 4 weeks a program of Mobilization with movement directed to thoracic vertebrae in mechanical neck pain , neck proprioception, sub-occipital angel ,scapular protraction and forward head posture in a form of 25 min for each session at totally twelfth sessions 20
Experimental Group Manipulation directed to thoracic spine 3 times per week successive 4 weeks at totally twelve session a programme of manipulation (quick thrust movement) directed to thoracic vertebrae in mechanical neck pain , neck proprioception, sub occipital angel, scapular protraction and forward head posture 20
Control Group Established mechanical neck pain treatment 3 times per week successive 4 weeks at totally twelve session a program of mechanical neck treatment based on published review contains five key set of exercises; neck muscle stretching, isometric contraction for neck muscle, chin in, scapular retraction and neck stabilizing exercise. 20 Active-Treatment of Control Group
ELIGIBILITY CRITERIA
List inclusion criteria List exclusion criteria Age Category Minimum age Maximum age Gender
1- Patients aged from 18-45 years old. 2- Patients with neck pain referred by physician. 3- Consent to participate in the study and follow the treatment schedule. 1. Any known case of cervical spine canal stenosis. 2. Previous history of malignancy. 3. History of whiplash injury, within 6 weeks of examination. 4. Any past history of cervico-thoracic surgery. 5. Patients with history of fractures of cervical and thoracic spine. 6. Patients diagnosed with, cervicogenic headache and vertigo. 7. Exposure to acute trauma. 8. Having history of inflammatory joint, muscle disease or infection. 9. Having an evidence of neurological deficit. 10. Exhibiting inadequate cooperation. 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 15/07/2021 Faculty of physical therapy cairo university research ethical comittee.
Ethics Committee Address
Street address City Postal code Country
El-Tahrir street cairo 012 00316 Egypt
OUTCOMES
Type of outcome Outcome Timepoint(s) at which outcome measured
Primary Outcome neck proprioception before and after intervention
Primary Outcome neck pain before and after intervention
Secondary Outcome sub occipital angel before and after intervention
Secondary Outcome scapular protraction before and after intervention
Secondary Outcome forward head posture before and after intervention
RECRUITMENT CENTRES
Name of recruitment centre Street address City Postal code Country
Out patients clinic physical therapy college Cairo university 7 Ahmed El Zayat street -Been El- Sarayat - Dokki- Giza Egypt Giza 11432 Egypt
FUNDING SOURCES
Name of source Street address City Postal code Country
Ola adel 7 Ahmed El Zayat street -Been El- Sarayat - Dokki Giza Egypt
Nabil mahmoud Ismail AbdelAal 7 Ahmed El Zayat street -Been El- Sarayat - Dokki Giza Egypt
Amir saleh 7 Ahmed El Zayat street -Been El- Sarayat - Dokki Giza 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 -Been El- Sarayat - Dokki Giza Egypt University
COLLABORATORS
Name Street address City Postal code Country
Nabil Mahmoud Ismail AbdelAal 7 Ahmed El Zayat street -Been El- Sarayat - Dokki Giza Egypt
CONTACT PEOPLE
Role Name Email Phone Street address
Principal Investigator Nabil Mahmoud Ismail Abdel Aal nabil.mahmoud@cu.edu.eg +201200133613 7 Ahmed El Zayat Street- Been El Sarayat- Dokki
City Postal code Country Position/Affiliation
Giza Egypt professor
Role Name Email Phone Street address
Scientific Enquiries Amir Mohamed Saleh amir.mohamed@cu.edu.eg 201200133613 7 Ahmed El Zayat street -Been El- Sarayat - Dokki- Giza Egypt
City Postal code Country Position/Affiliation
Giza Egypt professor of physiotherapy cairo university
Role Name Email Phone Street address
Public Enquiries Ola Adel olaadel509@yahoo.com 01030451609 7 Ahmed El Zayat street -Been El- Sarayat - Dokki- Giza Egypt
City Postal code Country Position/Affiliation
Giza Egypt demonastrator at physiotherapy 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 this article, after deidentification (text, tables, figures, and appendices) Clinical Study Report Beginning 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