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.: PACTR202111856730525 Date of Approval: 12/11/2021
Trial Status: Retrospective registration - This trial was registered after enrolment of the first participant
TRIAL DESCRIPTION
Public title Effectiveness of Eye-Cervical Re-education Versus Motor Imagery Therapy on Chronic Neck Pain : A Randomized Controlled Trial
Official scientific title Eye-Cervical Re-education Versus Motor Imagery Therapy on Chronic Neck Pain
Brief summary describing the background and objectives of the trial A Randomized Controlled Trial aims to compare the Effectiveness of Eye-Cervical Re-education Versus Motor Imagery Therapy on Cervical pain , function , proprioception ( neutral , target head ),ROM and scapular protraction in chronic neck pain patients
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 05/08/2021
Actual trial start date
Anticipated date of last follow up 05/11/2021
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
Parallel: different groups receive different interventions at same time during study Randomised Simple randomization using a randomization table created by a computer software program Numbered containers Masking/blinding used Participants
INTERVENTIONS
Intervention type Intervention name Dose Duration Intervention description Group size Nature of control
Control Group Conventional physical therapy 10 minutes of hot pack , 10 minutes therapeutic massage , cervical isometric strengthening exercises for all cervical movement with 5 repetition and Scapular Stabilization Exercise for Three laps of 10 repetitions , 3 seesion per week for four weeks four weeks hot pack , therapeutic massage , cervical isometric strengthening exercises for all cervical movement and Scapular Stabilization Exercise 20 Active-Treatment of Control Group
Experimental Group Eye Cervical Re education program 30 minutes conventional physical therapy followed by 30 minutes of Eye-Cervical Re-education program , 3seesion per week for 6 weeks four weeks Eye-Cervical Re-education program includes 10 exercises (Activation of ocular muscles,Passive mobilization of the cervical spine ,Analytical exercises on cervical mobility ,Global exercise of cervical movement,Cervical mobility work with the trunk ,Head reposition exercise (first degree) will be applied front of mirror ,Head reposition exercise (second degree) will be applied front of mirror with the therapist will be destabilized the patient in different direction,Free co-ordination exercise ,Manual resistance coordination exercise and Oculo-cervical coordination and multi directional stimuli 20
Experimental Group Motor Imagery therapy 30 minutes of conventional physical therapy followed by motor imagery therapy (the fist two phase will be applied 20 minutes , another phases will be applied 30 minutes ,3 session per week for four weeks four weeks Week 1: will be applied Kinesthetic imagery Week 2: will be applied a Motor imagery. Week 3: will be applied action observation with motor imagery. Week 4: will be applied the cervical motor control exercise in front of a mirror 20
ELIGIBILITY CRITERIA
List inclusion criteria List exclusion criteria Age Category Minimum age Maximum age Gender
1. Age will range from 20 to 45 years 2. Patients of both sexes. 3. Neck pain diagnosed by physician greater than 3 months in duration. 4.Active or latent myofascial trigger points (MTrPs) in at least one of the following muscles: upper trapezius, levator scapulae, or splenius capitis. Both active and latent MTrPs were considered because latent MTrPs have been associated with the development of sensory motor dysfunction 1. Dizziness syndrome. 2. Post-traumatic as whiplash 3. Neurological, infectious, or tumor cervical pain. 4. Pregnant women. 5. Patients having speech and understanding problems. 6. Past history of neck surgery Adult: 19 Year-44 Year 20 Year(s) 45 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 10/11/2020 Ethics committe physical therapy cairo university
Ethics Committee Address
Street address City Postal code Country
7 Ahmed EL Zayat Street -Been EL-Sarayat-Dokki-Giza Egypt Giza 11432 Egypt
OUTCOMES
Type of outcome Outcome Timepoint(s) at which outcome measured
Primary Outcome CROM device to measure cervical ROM , Proprioception neutral , target head Baseline and after 4 weeks
Primary Outcome pain pressure threshold by pressure algometer device Baseline and after 4 weeks
Secondary Outcome pain intensity level by VAS Baseline and after 4 weeks
Secondary Outcome Scapular Protraction by tap measurement Baseline and after 4 weeks
Secondary Outcome cervical function by The Arabic Version Of The Neck Functional Disability Scale Baseline and after 4 weeks
RECRUITMENT CENTRES
Name of recruitment centre Street address City Postal code Country
out patients clinic physical therapy college cairo 7 Ahmed EL Zayat street -Been EL- Saryat - dokki Giza 11432 Egypt
FUNDING SOURCES
Name of source Street address City Postal code Country
Randa Ahmed 7 Ahmed EL Zayat Street -Been EL -Sarayat -dokkki Giza 11432 Egypt
SPONSORS
Sponsor level Name Street address City Postal code Country Nature of sponsor
Primary Sponsor Randa Ahmed 7 Ahmed EL Zayat Street -Been EL -Sarayat -dokkki Giza 11432 Egypt University
COLLABORATORS
Name Street address City Postal code Country
Nabil Mahmoud AbdelAal 7 Ahmed EL Zayat Street -Been EL -Sarayat -dokkki Giza 11432 Egypt
Maher Ahmed El kablawy 7 Ahmed EL Zayat Street -Been EL -Sarayat -dokkki Giza 11432 Egypt
CONTACT PEOPLE
Role Name Email Phone Street address
Principal Investigator Nabil AbdelAal nabil.mahmoud@cu.edu.eg +201200133613 7 Ahmed EL Zayat Street -Been EL Sarayat-Dokki
City Postal code Country Position/Affiliation
Giza 11432 Egypt Assistant Profeesor of Physical Therapy Cairo University
Role Name Email Phone Street address
Public Enquiries Randa Amin Randaamin1311@hotmail.com +201013939174 7 Ahmed EL Zayat Street -Been EL Sarayat-Dokki
City Postal code Country Position/Affiliation
Giza 11432 Egypt Bachelor of physical therapy
Role Name Email Phone Street address
Scientific Enquiries Maher Elkabalawy nabil_45@hotmail.com +01001419544 7 Ahmed El zayat st. Been Elsarayat,
City Postal code Country Position/Affiliation
Dokki Giza Egypt Professor of Physical Therapy Ciro University
REPORTING
Share IPD Description Additional Document Types Sharing Time Frame Key Access Criteria
Yes Individual particpant data that underlie the results reported in this article, after deidentification ( text , tables, figures and appendices) Clinical Study Report Beginning 9 months and ending 36 months following the article publication The study will be published in scientific journal
URL Results Available Results Summary Result Posting Date First Journal Publication Date
Not available now 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