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.: PACTR201806003435331 Date of Approval: 31/05/2018
Trial Status: Registered in accordance with WHO and ICMJE standards
TRIAL DESCRIPTION
Public title Forward head posture correction: Neurophysiological study
Official scientific title Does forward head posture correction affect pain sensitivity ,Neuroplastic Changes and autonomic nervous system function in patients with chronic nonspecific neck pain ?: A randomized-controlled trial.
Brief summary describing the background and objectives of the trial the previously mentioned studies make a significant contribution to understanding the important role of a normal cervical lordotic curve, still there is a lack of literature regarding the neurophysiological consequences for restoring the normal head posture especially related to autonomic function and Neuroplastic Changes.. Accordingly, in the current study, we address three main questions: (1) whether forward head correction may lead to reorganizational processes within the somatosensory pathway; (2) at what level this mechanical malalignment related modulation might takes place; and (3) to identify any role that sagittal cervical improvement plays in sympathetic skin response (SSR), which has been recommended as a measure for investigating sympathetic nervous system function . We hypothesize that improvement in sagittal cervical alignment will positively alter sympathetic cholinergic sudomotor function and central processing.
Type of trial RCT
Acronym (If the trial has an acronym then please provide)
Disease(s) or condition(s) being studied forward head posture,Injury, Occupational Diseases, Poisoning,Musculoskeletal Diseases
Sub-Disease(s) or condition(s) being studied
Purpose of the trial Treatment: Other
Anticipated trial start date 05/06/2018
Actual trial start date 05/06/2018
Anticipated date of last follow up 05/12/2018
Actual Last follow-up date
Anticipated target sample size (number of participants) 80
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 Permuted block randomization with variable block size Sealed opaque envelopes Masking/blinding used Outcome Assessors
INTERVENTIONS
Intervention type Intervention name Dose Duration Intervention description Group size Nature of control
Experimental Group posture corrective exercise program the intervention was repeated three times per week for 6 weeks The total session time is 60 minutes Forward Head Posture Corrective Exercise Program This exercise program consisted of 2 strengthening (of the deep cervical flexors and shoulder retractors) and 2 stretching (of the cervical extensors and pectoral muscles) exercises 40
Control Group conventional treatment the intervention was repeated three times per week for 6weeks The total session time is 60 minutes The patients in both groups completed a 6-week multimodal program consisting of physical pain relief methods, cervical spine mobilization, and myofascial release 40 Active-Treatment of Control Group
ELIGIBILITY CRITERIA
List inclusion criteria List exclusion criteria Age Category Minimum age Maximum age Gender
If the craniovertebral angle angle <50, then a participant will participate in the study Patients will be included if they were 18 years of age or over. have unilateral or bilateral chronic neck pain more than 3 months duration. will be able to attend a full course of 18 treatments given three times a week the presence of any of the following: (i) systemic pathology including any inflammatory joint disease. (ii) prior history of overt injury or surgery relating to the musculoskeletal system. disorder related to the spine and extremities. (iii) musculoskeletal pain in the last three months Adolescent: 13 Year-18 Year,Adult: 19 Year-44 Year,Middle Aged: 45 Year(s)-64 Year(s) 18 Year(s) 50 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 02/01/2018 Research Ethics Committee-Faculty of Physical Therapy-Cairo University
Ethics Committee Address
Street address City Postal code Country
7-Ahmed El zaiat St-ben Elsaryat-El Dokki-Giza Giza 12612 Egypt
OUTCOMES
Type of outcome Outcome Timepoint(s) at which outcome measured
Primary Outcome Cervical sagittal alignment pre-treatment after 6 weeks of treatment at 6-month follow up
Secondary Outcome Neurophysiological findings :central somatosensory conduction time , and amplitudes of spinal N13, brainstem P14, parietal N20 and P27, and frontal N30 potentials addition to amplitude and latency of sympathetic skin response pre-treatment after 6 weeks of treatment at 6-month follow -up
RECRUITMENT CENTRES
Name of recruitment centre Street address City Postal code Country
Faculty of Physical Therapy-Cairo university Faculty of Physical therapy, Cairo University, Ben El Sarayat St., Giza Square, Giza. Giza 11765 Egypt
FUNDING SOURCES
Name of source Street address City Postal code Country
not funded till now
SPONSORS
Sponsor level Name Street address City Postal code Country Nature of sponsor
Primary Sponsor Ibrahim Moustafa Moustafa 7-Mohamed Hassan El-Gamel st,Naser City cairo 11765 Egypt Charities/Societies/Foundation
COLLABORATORS
Name Street address City Postal code Country
Aliaa A Diab 7-Mohamed Hassan El-Gamel st,Naser City cairo 11765 Egypt
CONTACT PEOPLE
Role Name Email Phone Street address
Principal Investigator ibrahim moustafa ibrahiem.mostafa@pt.cu.edu.eg 002012270223 7-Mohamed Hassan El-Gamel st,Naser City
City Postal code Country Position/Affiliation
Cairo 12612 Egypt Assistant professor Basic science department,Faculty of Physical therapy, Cairo University
Role Name Email Phone Street address
Public Enquiries Aliaa Diab aliaa.atya@pt.cu.edu.eg 00201003627372 7-Mohamed Hassan El-Gamel st,Naser City
City Postal code Country Position/Affiliation
Cairo 12612 Egypt professor Basic science department,Faculty of Physical therapy, Cairo University
Role Name Email Phone Street address
Scientific Enquiries ibrahim moustafa ibrahiem.mostafa@pt.cu.edu.eg 002012270223 7-Mohamed Hassan El-Gamel st,Naser City
City Postal code Country Position/Affiliation
Cairo 12612 Egypt Assistant professor Basic science department,Faculty of Physical therapy, Cairo University
REPORTING
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