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.: PACTR201703002102112 Date of Registration: 14/03/2017
Trial Status: Registered in accordance with WHO and ICMJE standards
TRIAL DESCRIPTION
Public title Prone versus Supine Traction in Treatment of Cervical Disc Bulge
Official scientific title Efficacy of prone versus supine traction on the size of disc bulge,neck pain and neck function in patients with cervical disc bulge
Brief summary describing the background and objectives of the trial Disc injury or degeneration could lead to mechanical compression or chemical irritation of the nerve root causing neurological deficits. Spinal traction is generally regarded as a conservative management in treating various types of neck or back disorders, Spinal traction could widen the intervertebral disc space reflecting a stretching effect for the posterior longitudinal ligaments and this condition might be associated with the suction effect of the negative intra discal pressure and the pushing effect of the posterior longitudinal ligament. The position of patient during traction is an important factor that affects on the outcomes of treatments, Cervical traction is usually administered with patients in supine or sitting position and the previous studies mainly focused on the supine position. There are previous studies about prone traction but on lumbar spine by using the newly developed lumbar traction system, creation of negative intradiscal pressure in prone position is important to suck back herniated disc material with distraction of lumbar vertebrae. Cervical traction from prone position maintains anatomical and mechanical benefits that allow the nucleus palposus of the bulged disc to return back to its original position within the annulus fibrosus when its way is opened by traction between the two vertebral bodies. Purpose of the study is to provide the physical therapy with scientific based knowledge about the most effective position for cervical traction in treatment of cervical disc bulge. A pilot study will be conducted to detect the sample size. The patients of both genders with chronic posterolateral cervical disc bulge at level of C5-C6 or C6-C7 will participate in this study with age ranging from 40 to 50 years old.The patients will be randomly assigned into three equal groups: A,B and C. the size of the bulged disc will be assessed by MRI, pain will be assessed by VAS and neck function will be assessed by NDI pre and post treatment.
Type of trial RCT
Acronym (If the trial has an acronym then please provide) MRI VAS NDI
Disease(s) or condition(s) being studied Cervical disc bulge
Sub-Disease(s) or condition(s) being studied
Purpose of the trial Treatment: Other
Anticipated trial start date 01/06/2017
Actual trial start date
Anticipated date of last follow up 01/09/2018
Actual Last follow-up date
Anticipated target sample size (number of participants) 60
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
Factorial: participants randomly allocated to either no, one, some or all interventions simultaneously Randomised The patients will be assigned randomly by random generator and by using permuted block the allocation will be determined by a third person Open-label(Masking Not Used)
INTERVENTIONS
Intervention type Intervention name Dose Duration Intervention description Group size Nature of control
Experimental Group prone traction + traditional physical therapy programe three times per week one month continuous cervical traction from prone position +Infra red+ ultra sound+stretching and isometric strengthening exercises for neck muscles 20
Experimental Group supine traction + traditional physical therapy program three times per week one month continuous cervical traction from supine position +Infra red+ ultra sound+stretching and isometric strengthening exercises for neck muscles 20
Control Group Traditional physical therapy program for cervical disc three times per week one month Infra red+ ultra sound+stretching and isometric strengthening exercises for neck muscles 20 Active-Treatment of Control Group
ELIGIBILITY CRITERIA
List inclusion criteria List exclusion criteria Age Category Minimum age Maximum age Gender
Inclusion criteria: 1.Patients with cervical disc bulge of C5, C6 and/or C6, C7 levels diagnosed by MRI. 2.Chronic stage (more than three months). 3.Their age ranged from 40 to50 years. 4.BMI ranged from 25 to 30 kg /m2. ¿ Exclusion criteria: 1.Patients who undergo to any previous cervical spine operations. 2. Medical ¿red flags¿ (eg, tumor, fracture, myelopathy, osteoporosis). Patient with herniated cervical disc with sequestration. 3.Patients with central canal stenosis. 4.patients with any contraindications to prone position. 40 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
No 12/04/2017 Faculty of physical therapy
Ethics Committee Address
Street address City Postal code Country
7 el zaiat street Giza Egypt
OUTCOMES
Type of outcome Outcome Timepoint(s) at which outcome measured
Primary Outcome The size of disc bulge Pre and post completion of treatment
Primary Outcome cervical pain pre and post completion of treatment
Secondary Outcome neck function pre and post completion of treatment
RECRUITMENT CENTRES
Name of recruitment centre Street address City Postal code Country
Kasr El- Eini Hospital Kasr EL- Eini street Giza Egypt
FUNDING SOURCES
Name of source Street address City Postal code Country
Personal hadayek el kobba cairo Egypt
SPONSORS
Sponsor level Name Street address City Postal code Country Nature of sponsor
Primary Sponsor Cairo university Giza Egypt University
COLLABORATORS
Name Street address City Postal code Country
Dr.Wadida Hassan alsudan street Giza Egypt
Dr.Rania Nagy downtown street cairo Egypt
CONTACT PEOPLE
Role Name Email Phone Street address
Principal Investigator Wadida Hassan Dr.wadida.hassan@gmail.com 01001097571 alsudan street
City Postal code Country Position/Affiliation
Giza Egypt prof doctor
Role Name Email Phone Street address
Public Enquiries Ahmed Aboul Fotouh ahmedelmasry_01@yahoo.com 01008430897 wally el ahd street
City Postal code Country Position/Affiliation
cairo Egypt
Role Name Email Phone Street address
Scientific Enquiries Rania Nagy rania.nagy@pt.cu.edu.eg 01227244630 downtown street
City Postal code Country Position/Affiliation
cairo Egypt Dr
REPORTING
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