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.: PACTR201510001281351 Date of Approval: 28/09/2015
Trial Status: Registered in accordance with WHO and ICMJE standards
TRIAL DESCRIPTION
Public title The Effect of cervical lordosis rehabilitation on pain, disability and vertebral artery blood flow in non-specific neck pain
Official scientific title The Effect of cervical lordosis rehabilitation on pain, disability and vertebral artery blood flow in non-specific neck pain
Brief summary describing the background and objectives of the trial our trial will describe the effect of rehabilitation of cervical lordosis on disability , pain and vertebral artery blood flow in non-specific neck pain by using deneroll orthotic equipment
Type of trial RCT
Acronym (If the trial has an acronym then please provide)
Disease(s) or condition(s) being studied Musculoskeletal Diseases,non-specific neck pain
Sub-Disease(s) or condition(s) being studied
Purpose of the trial Treatment: Devices
Anticipated trial start date 09/11/2015
Actual trial start date 15/08/2016
Anticipated date of last follow up 30/01/2016
Actual Last follow-up date
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
Factorial: participants randomly allocated to either no, one, some or all interventions simultaneously Randomised Permuted block randomisation Sealed opaque envelopes Open-label(Masking Not Used)
INTERVENTIONS
Intervention type Intervention name Dose Duration Intervention description Group size Nature of control
Experimental Group rehabilitation physical therapy program plus deneroll deneroll : for 20 minutes per session two monthes rehabilitation program by using physical therapy passive modalities such as ( infra red - physical ultra sound and electrical stimulation ) plus using the deneroll orthotic traction 30
Control Group physical therapy rehabilitation program only 3 sessions per week two monthes physical therapy rehabilitation program include passive modalities such as infra red , ultrasonic and electrical stimulation only 30
ELIGIBILITY CRITERIA
List inclusion criteria List exclusion criteria Age Category Minimum age Maximum age Gender
1)The patients are diagnosed by hypolordosis /mild to moderate nonspecific pain of cervical spine by using plain x-ray for measuring lateral cervical view to detect the degree of absolute rotatory angle 2)The patients are diagnosed by vertebral artery blood flow by using ultrasound Doppler. 3)Thirty patients their age ranged from 25- 55 years. 4)Patient¿s chronicity ¿ level of pain. (1) Fracture, osteoporosis, positive extension-rotation test, any symptom of vertebrobasilar insufficiency. (2) History of whiplash. (3) History of cervical surgery. (4) Diagnosis of cervical radiculopathy or myelopathy. (5) Diagnosis of fibromyalgia syndrome. 25 Year(s) 55 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 01/11/2015 research ethical commitie - faculty of physical therapy - cairo university
Ethics Committee Address
Street address City Postal code Country
Masaken Al Amireyah Al Ganoubeyah, Giza, Cairo Governorate giza , 11611 Egypt
OUTCOMES
Type of outcome Outcome Timepoint(s) at which outcome measured
Primary Outcome Functional Neck Disability 10 points as clinical significant difference
Secondary Outcome Pain Intensity 0 indicates no pain 10 indicates maximum pain
Secondary Outcome Absolute Rotatory Angle Normal angle ranges between 34° to 42 °
RECRUITMENT CENTRES
Name of recruitment centre Street address City Postal code Country
out patient clinic of facultyof physical therapy , october 6 university Seventh district - next to the central axis 6 october Egypt
FUNDING SOURCES
Name of source Street address City Postal code Country
self funded 9 at el khalifa el rady street , seventh district , nasr city , Cairo , Egypt cairo 00202 Egypt
SPONSORS
Sponsor level Name Street address City Postal code Country Nature of sponsor
Primary Sponsor cairo university Cairo University Street, Renaissance Square giza Egypt University
COLLABORATORS
Name Street address City Postal code Country
cairo university Cairo University Street, Renaissance Square cairo Egypt
CONTACT PEOPLE
Role Name Email Phone Street address
Principal Investigator saied ibrahem saiedibrahem83@gmail.com +201004677678 9 at el khalifa el rady street , seventh district , nasr city , Cairo , Egypt
City Postal code Country Position/Affiliation
cairo 11511 Egypt assistant lectrur
Role Name Email Phone Street address
Public Enquiries Saied Ibrahem saiedibrahem83@gmail.com +201004677678 9 at el khalifa el rady street , seventh district , nasr city ,
City Postal code Country Position/Affiliation
Cairo Egypt Assistent Lecturer
Role Name Email Phone Street address
Scientific Enquiries saied ibrahem saied.moamed.pt@o6u.edu.eg +201004677678 9 at el khalifa el rady street , seventh district , nasr city , Cairo , Egypt
City Postal code Country Position/Affiliation
cairo 11511 Egypt assistant lectrur
REPORTING
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Result URL Hyperlinks Link To Protocol
Result URL Hyperlinks
Changes to trial information