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.: PACTR201703002068409 Date of Approval: 02/03/2017
Trial Status: Retrospective registration - This trial was registered after enrolment of the first participant
TRIAL DESCRIPTION
Public title Neurophysiological changes after cervical lordosis rehabilitation
Official scientific title Demonstration of Central Conduction Time and Neuroplastic Changes after Cervical Lordosis Rehabilitation in Asymptomatic Subjects: A randomized, placebo-controlled trial
Brief summary describing the background and objectives of the trial The assumption that restoring normal cervical spine alignment is essential for a better afferentation process and is important for restoring the normal mechanics for the central nervous system , has some evidence. However, the question of whether cervical biomechanical dysfunction represented in reduced cervical lordosis and anterior head translation may play a crucial role in promoting cortical ,subcortical and spinal reorganization in humans and central conduction time ,even in asymptomatic subjects, has not been answered yet. Accordingly, in the current study, we address three main questions: (1) whether cervical sagittal alignment without the presence of pain 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 somatosensory central conduction. We hypothesize that improvement in sagittal cervical alignment will positively alter somatosensory central conduction and central processing.
Type of trial RCT
Acronym (If the trial has an acronym then please provide)
Disease(s) or condition(s) being studied Asymptomatic Subjects,Musculoskeletal Diseases
Sub-Disease(s) or condition(s) being studied
Purpose of the trial Treatment: Other
Anticipated trial start date 05/09/2016
Actual trial start date 05/09/2016
Anticipated date of last follow up 10/10/2016
Actual Last follow-up date 01/02/2017
Anticipated target sample size (number of participants) 80
Actual target sample size (number of participants) 80
Recruitment status Completed
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 of different sizes 4,6,8 Sealed opaque envelopes Masking/blinding used Outcome Assessors,Participants
INTERVENTIONS
Intervention type Intervention name Dose Duration Intervention description Group size Nature of control
Experimental Group Denneroll extension traction the intervention was repeated three times per week for 10 weeks three minutes and increased one minute per session until reaching the goal of 20 minutes per session The participants were instructed to lie flat on their back on the ground with their legs extended and arms by their sides gently folded across their stomach. The subject placed the denneroll on the ground and the examiner positioned the apex of the denneroll in one of two regions (mid cervical placement and lower cervical placement)depending on the apex of each participant¿s cervical curvature 40
Control Group placebo intervention three times per week for 10 weeks the duration of each session started at approximately three minutes and increased one minute per session until reaching the goal of 20 minutes per session The control group was treated with a placebo treatment using a small cervical towel located in the mid cervical spine as an intervention to mimic the denneroll traction; but without applying significant extension bending of the cervical spine. 40 Placebo
ELIGIBILITY CRITERIA
List inclusion criteria List exclusion criteria Age Category Minimum age Maximum age Gender
the AHT distance was more than 15 mm. ARA C2-C7 was less than 25° systemic pathology including any inflammatory joint disease. prior history of overt injury or surgery relating to the musculoskeletal system. disorder related to the spine and extremities. musculoskeletal pain in the last three months. 19 Year(s) 27 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 05/07/2016 Faculty of physical therapy research ethical committee
Ethics Committee Address
Street address City Postal code Country
Faculty of Physical Therapy, Cairo University, Ben El Sarayat St., Giza square, Giza. Giza 12613 Egypt
OUTCOMES
Type of outcome Outcome Timepoint(s) at which outcome measured
Primary Outcome AHT distance and cervical lordotic angle (ARA C2-C7) pretreatment. the next day following the completion of 30 visits over the 10 weeks of treatment. at 3-months follow-up after the 10 weeks of treatment re-evaluation.
Secondary Outcome Neurophysiological findings (central somatosensory conduction time (N13-N20), and amplitudes of spinal N13, brainstem P14, parietal N20 and P27, and frontal N30 potentials pretreatment. the next day following the completion of 30 visits over the 10 weeks of treatment. at 3-months follow-up after the 10 weeks of treatment re-evaluation.
RECRUITMENT CENTRES
Name of recruitment centre Street address City Postal code Country
Faculty of Physical Therapy 7 Ahmed El Zayyat St., Dokki, Giza Giza 12613 Egypt
FUNDING SOURCES
Name of source Street address City Postal code Country
CBP Nonprofit (a spine research foundation 950 E Riverside Eagle, ID 83616 ID United States of America
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
Ibrahim Moustafa Moustafa 7-Mohamed Hassan El-Gamel st,Naser City cairo 11765 Egypt
Aliaa A Diab 7-Mohamed Hassan El-Gamel st,Naser City cairo 11765 Egypt
shimaa taha Faculty of Physical therapy, Cairo University, Ben El Sarayat St., Giza Square, Giza. Giza 12613 Egypt
Deed E Harrison CBP NonProfit (a spine research foundation), Eagle, ID, USA 83616 ID United States of America
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 Egypt Assistant professor Basic science department,Faculty of Physical therapy, Cairo University
Role Name Email Phone Street address
Public Enquiries Shimaa Taha Elshazly dr.shymaelshazly@yahoo.com 00201229823327 Ben El Sarayat St.,
City Postal code Country Position/Affiliation
Cairo Egypt Faculty of physical therapy, cairo university
Role Name Email Phone Street address
Scientific 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 Egypt Assistant professor Basic science department,Faculty of Physical therapy, Cairo University
Role Name Email Phone Street address
Scientific Enquiries Deed Harrison drdeed@idealspine.com 1997-2011 950 E Riverside
City Postal code Country Position/Affiliation
Eagle, ID United States of America DC:CBP NonProfit (a spine research foundation)
REPORTING
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