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.: PACTR202008706009335 Date of Registration: 05/08/2020
Trial Status: Registered in accordance with WHO and ICMJE standards
TRIAL DESCRIPTION
Public title Mulligan mobilization for neck pain
Official scientific title Efficacy of mulligan mobilization technique added to cervical postural correction for adults with cervical disc bulge: A randomized blinded controlled trial
Brief summary describing the background and objectives of the trial Cervical disc prolapse is a common problem that affects many people, and causes pain, limitations of cervical range of motion and deteriorated functional activities. The purpose of the study was to examine the efficacyt of Mulligan exercise on outcomes related to cervical disc prolapse
Type of trial RCT
Acronym (If the trial has an acronym then please provide)
Disease(s) or condition(s) being studied Musculoskeletal Diseases,Nervous System Diseases
Sub-Disease(s) or condition(s) being studied
Purpose of the trial Rehabilitation
Anticipated trial start date 01/08/2020
Actual trial start date 01/08/2020
Anticipated date of last follow up 01/10/2020
Actual Last follow-up date 01/10/2020
Anticipated target sample size (number of participants) 50
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 Simple randomization using a randomization table created by a computer software program Sealed opaque envelopes Masking/blinding used Outcome Assessors,Participants
INTERVENTIONS
Intervention type Intervention name Dose Duration Intervention description Group size Nature of control
Control Group cervical posture correction 3 sessions/ week 4 weeks hot packs applied on cervical extensors stretching of cervical extensors and protracors strengthening of retractors and deep cervical flexors 25 Active-Treatment of Control Group
Experimental Group Mulligan technique 3 sessions per week 12 weeks Apply NAGs mulligan mobization With traditional program composed of hot packs, streching of Cervical extensors and protractors and strengthning of retractoras and cervical deep flexors 25
ELIGIBILITY CRITERIA
List inclusion criteria List exclusion criteria Age Category Minimum age Maximum age Gender
Neck pain Disability Cervical disc bulge Current participation in Physical or medical treatment for neck pain Any defined other pathologies Scoluosis Visual or auditory problems Adult: 19 Year-44 Year 20 Year(s) 40 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 22/07/2020 Research erhics committee of Faculty of Physical Therapy Cairo University
Ethics Committee Address
Street address City Postal code Country
7 Ahmed elzayat street Cairo 221890 Egypt
OUTCOMES
Type of outcome Outcome Timepoint(s) at which outcome measured
Primary Outcome Pain Immediatly before and after the treatment program
Secondary Outcome Neck disability Immediatly before and after the treatment program
Secondary Outcome Cervical range of motion Immediatly before and after the treatment program
RECRUITMENT CENTRES
Name of recruitment centre Street address City Postal code Country
Pharos University Elmahmoudeya street Alexandria 36741 Egypt
FUNDING SOURCES
Name of source Street address City Postal code Country
Aliaa M Elabd Sabry aboallam Alexandria Egypt
SPONSORS
Sponsor level Name Street address City Postal code Country Nature of sponsor
Primary Sponsor Aliaa M Elabd Sabry aboallam Alexandria 29634 Egypt Individual
COLLABORATORS
Name Street address City Postal code Country
Omar M Elabd Hamdy kandil Shebin Elkom Egypt
CONTACT PEOPLE
Role Name Email Phone Street address
Principal Investigator Aliaa Elabd aliaelabd88@gmail.com 00201069352446 Sabry aboallam
City Postal code Country Position/Affiliation
Alexandria Egypt Lecturer Faculty of Physical Therapy pharos university
Role Name Email Phone Street address
Public Enquiries Aliaa Elabd aliaelabd88@gmail.com 00201069352446 Sabry aboallam
City Postal code Country Position/Affiliation
Alexandria Egypt Lecturer Faculty of Physical Therapy pharos university
Role Name Email Phone Street address
Scientific Enquiries Aliaa Elabd aliaelabd88@gmail.com 00201069352446 Sabry aboallam
City Postal code Country Position/Affiliation
Alexandria Egypt Lecturer Faculty of Physical Therapy pharos university
REPORTING
Share IPD Description Additional Document Types Sharing Time Frame Key Access Criteria
Yes All individual participant data collocted during the Trial after identification Analytic Code,Clinical Study Report,Informed Consent Form,Statistical Analysis Plan,Study Protocol Immediatly after publication without end Any one
URL Results Available Results Summary Result Posting Date First Journal Publication Date
No
Result Upload 1: Result Upload 2: Result Upload 3: Result Upload 4: Result Upload 5:
Result URL Hyperlinks Link To Protocol
Result URL Hyperlinks
Changes to trial information