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.: PACTR201604001574574 Date of Approval: 08/04/2016
Trial Status: Retrospective registration - This trial was registered after enrolment of the first participant
TRIAL DESCRIPTION
Public title Lordosis, Disc Herniation and Cervical Radiculopathy
Official scientific title The effectiveness of rehabilitation of cervical lordosis for the improvement of pain, disability, peripheral and central nervous function in patients with discogenic cervical radiculopathy? A 1-Year Pilot Randomized Controlled Trial
Brief summary describing the background and objectives of the trial BACKGROUND: The benefits of restoring normal cervical sagittal configuration in addition to multimodal program, in people with DCR are not well established. OBJECTIVE: To investigate the immediate and 1-year effects of a multimodal program, with cervical lordosis and anterior head translation (AHT) rehabilitation, on the severity of pain, disability, peripheral and central nervous system function in patients with discogenic cervical radiculopathy (DCR).60 (37 males) patients with chronic DCR, a defined hypolordotic cervical spine and AHT posture were randomly assigned to the control or an experimental group. Both groups received the multimodal program; additionally, the experimental group received the denneroll cervical traction device. Outcome measures included AHT, cervical lordosis, arm pain, neck pain and disability (NDI), dermatomal somatosensory evoked potentials (DSSEP¿s) and central somatosensory conduction time (N13-N20). Measures were assessed at three time intervals
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 02/03/2014
Actual trial start date 07/09/2014
Anticipated date of last follow up 25/11/2015
Actual Last follow-up date 28/01/2016
Anticipated target sample size (number of participants) 60
Actual target sample size (number of participants) 60
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 with different block sizes 4, 6, 8 Sealed opaque envelopes Masking/blinding used Outcome Assessors
INTERVENTIONS
Intervention type Intervention name Dose Duration Intervention description Group size Nature of control
Control Group multimodal program All the multimodal program components were repeated three times per week for 10 weeks, except the thrust manipulation, which was performed once a week for the 10 consecutive weeks 10 weeks The patients in both groups completed a 10-week multimodal program consisting of physical pain relief methods, thoracic spine manipulation, myofascial release, and therapeutic exercises 30 Active-Treatment of Control Group
Experimental Group Denneroll extension traction+ mutlimodal program three times per week 10 weeks In addition to the multimodal programs, the participants in the experimental group also received the denneroll cervical orthotic. The patient 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 deformity. 30
ELIGIBILITY CRITERIA
List inclusion criteria List exclusion criteria Age Category Minimum age Maximum age Gender
Subjects were included if the AHT distance was more than 15. their ARA was less than 25° . they had a unilateral C7 discogenic radiculopthy . C7 dermatomal numbness. current continuous or intermittent pain or discomfort which had persisted for more than 3 months. radiation of arm pain in the representative dermatomal areas for C7. diminished deep tendon reflexes in the affected arm. the four positive examination findings (Spurling test, upper limb tension test, cervical distraction test, and less than 60° cervical rotation towards the symptomatic side). side to side amplitude differences of 50% or more in dermatomal somatosensory evoked potentials. duration of symptoms more than 3 months. Exclusion criteria included the presence of any signs or symptoms of medical "red flags" (e.g., tumor, fracture, rheumatoid arthritis, osteoporosis, and prolonged steroid use). A history of previous cervical or thoracic spine surgery. signs or symptoms of upper motor neuron disease. vestibulobasilar insufficiency. amyotrophic lateral sclerosis. bilateral upper extremity radicular symptoms. pregnant woman. inability to tolerate cervical flexion or extension position. the complete loss of sensation along the involved nerve root. intractable pain. myelopathy. 35 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 06/05/2014 Research Ethics Committee-Faculty of Physical Therapy-Cairo University
Ethics Committee Address
Street address City Postal code Country
7 Ahmed Elzaiat St. Ben Elsaryat - EI Dokki-Giza - Egypt. Giza 12612 Egypt
OUTCOMES
Type of outcome Outcome Timepoint(s) at which outcome measured
Primary Outcome disability measured using the valid and reliable neck disability index pre treatment after 10 weeks after one year
Secondary Outcome cervical sagittal alignment, and the neurophysiological findings (latency and peak-to-peak amplitude of DSSEPs) in addition to central somatosensory evoked potential N13-N20. pre treatment after 10 weeks after one year
RECRUITMENT CENTRES
Name of recruitment centre Street address City Postal code Country
Faculty of Physical Therapy-Cairo University 7 Ahmed Elzaiat St. Ben Elsaryat - EI Dokki-Giza - Egypt. Giza 12612 Egypt
FUNDING SOURCES
Name of source Street address City Postal code Country
CBP Non-Profit (a spine research foundation), Eagle, ID, USA 950 E Riverside Dr Eagle 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 Moahmed Hassan Elgamel st-Nacer City Cairo 12612 Egypt University
COLLABORATORS
Name Street address City Postal code Country
Ibrahim Moustafa Moustafa 7 Moahmed Hassan Elgamel st-Nacer City Cairo 12612 Egypt
Aliaa A Diab 7 Moahmed Hassan Elgamel st-Nacer City Cairo 12612 Egypt
Deed E Harrison Eagle, ID, USA Eagle United States of America
Shimaa Taha 7 Ahmed Elzaiat St. Ben Elsaryat - EI Dokki-Giza - Egypt. Giza Egypt
CONTACT PEOPLE
Role Name Email Phone Street address
Principal Investigator ibrahim moustafa ibrahiem.mostafa@pt.cu.edu.eg 00201227022334 7-Mohamed Hassan El-Gamel st,Naser City
City Postal code Country Position/Affiliation
cairo 12612 Egypt Assistant professor - Basic science departmen,Faculty of Physical therapy, Cairo University
Role Name Email Phone Street address
Public Enquiries Aliaa Diab aliaa.atya@pt.cu.edu.eg 0020223496747 7-Mohamed Hassan El-Gamel st,Naser City
City Postal code Country Position/Affiliation
cairo 12612 Egypt Assistant professor - Basic science departmen,Faculty of Physical therapy, Cairo University
Role Name Email Phone Street address
Public Enquiries shimaa taha dr.ibrahim5@gmail.com 00201229823327 7 Ahmed Elzaiat St. Ben Elsaryat - EI Dokki-Giza - Egypt.
City Postal code Country Position/Affiliation
cairo 12345 Egypt Assistant lecturer - Basic science departmen,Faculty of Physical therapy, Cairo University
REPORTING
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