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.: PACTR201907687491660 Date of Approval: 16/07/2019
Trial Status: Retrospective registration - This trial was registered after enrolment of the first participant
TRIAL DESCRIPTION
Public title Effect of active release technique versus myofascial release technique on mechanical low back pain
Official scientific title Effect of active release technique versus myofascsial release technique on mechanical low back pain
Brief summary describing the background and objectives of the trial Mechanical low back pain is the most common cause of pain and function disability among societies muscles of the lumbar spine has been demonstrated as primary source of back and buttock pain predominantly the musculature of lumbar spine include muscle strain spasm myofascial complaints. Active release technique according to Australian sports therapy involve tension or massage and guided movement aiming to remove soft tissue adhesions by tissue tension. The purpose of the study is to compare the effect of active release technique to the myofascial release technique on pain, function disability level and range of motion using a BROM device measuring back range of motion
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 Treatment: Devices
Anticipated trial start date 15/02/2019
Actual trial start date 01/03/2019
Anticipated date of last follow up 29/08/2019
Actual Last follow-up date 25/09/2019
Anticipated target sample size (number of participants) 30
Actual target sample size (number of participants) 25
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 Simple randomization using a randomization table created by a computer software program Numbered containers Open-label(Masking Not Used)
INTERVENTIONS
Intervention type Intervention name Dose Duration Intervention description Group size Nature of control
Experimental Group group B myofascial release for quadratus lambourm erectrospinae gluteus medius and hamstring 3times per week day after day 1 month myofascial release for trigger points for both muscles of gluteus medius ,sustained pressure will apply following,barrier upon barrier for minimum 2 min or until a release occur and also for quadratus lambourm and hamstring muscles 10
Experimental Group groupA of active release technique 3 times per week day after day 1 month active release for gletus medius trigger points ,in form of apply gentle tension and ask the the patient to perform active movement from shortening to lengthening position while hold the tissue tension 10
Control Group group C conventional physical therapy in form of infra red and therapeutic exercise 3 times per week day after day 1 month exercise back extension from prone .bridging exercise ,sit up exercise and posterior pelvic tilt exercise done 10 times with 6 seconds hold 10 Active-Treatment of Control Group
ELIGIBILITY CRITERIA
List inclusion criteria List exclusion criteria Age Category Minimum age Maximum age Gender
- Patients diagnosed as mechanical LBP due to myogenic cause - Patient will has active trigger point at least two points in each muscle (erectrospinae ,quadratus lambourum , gluteus medius and hamstring ) 1- Patients suffering from neurological diseases 2- Patients with nerve root disorders 3- Subjects with spinal pathology (Tumors & inflammatory diseases including spondylitis, scoliosis, spondylithesis) 4- Pregnant women 5- motor weakness 6- priformis syndrome 7- Patients suffering from infection or skin lesions 8- Patients with sensory disorders 9- Patients under gone back spinal surgery 10- Diabetic patients Adult: 19 Year-44 Year 20 Year(s) 41 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 14/06/2018 Faculty of physical therapy
Ethics Committee Address
Street address City Postal code Country
El tahrir street -in front of Ben Elsarayat traffic-Dokki -Giza Cairo 11432 Egypt
OUTCOMES
Type of outcome Outcome Timepoint(s) at which outcome measured
Primary Outcome pain ,pressure pain thershold using algometer .pain using NPRS numerical pain rating scale pre and post intervention measurement
Secondary Outcome back range of motion using BROM measuring back flexion extension ,right and left side bending and trunk rotation, and functional activity using Ronald Morris disability questionnaire RMDQ pre and post intervention
RECRUITMENT CENTRES
Name of recruitment centre Street address City Postal code Country
Matareyah teaching hospital one of general organization of teaching hospitals and institutes Ali Mekkawy Qesm al Matareyah Cairo 11753 Egypt
FUNDING SOURCES
Name of source Street address City Postal code Country
Reham Mokhtar Abdel Sadek 28 dar el saad building elzaytoun Cairo 11321 Egypt
SPONSORS
Sponsor level Name Street address City Postal code Country Nature of sponsor
Primary Sponsor Faculty of physical therapy Cairo university 7 Ahmed El Zayat street Giza 12613 Egypt University
COLLABORATORS
Name Street address City Postal code Country
DR Wadida Hassan 7 Ahmed El Zayat street Giza Egypt
CONTACT PEOPLE
Role Name Email Phone Street address
Principal Investigator Reham Mokhtar mokhtarreham89@yahoo.com 00201001453533 28 Dar El Saad building El Zaytoun
City Postal code Country Position/Affiliation
Cairo 11321 Egypt specialist physical therapy
Role Name Email Phone Street address
Public Enquiries Waddida Hassan dr.wadida.hassan@gmail.com +201001097571 7 Ahmed el Zayat street
City Postal code Country Position/Affiliation
Giza 12613 Egypt professor doctor of physical therapy
Role Name Email Phone Street address
Scientific Enquiries Dooa Ibrahim doaaamin38@yahoo.com +20100481999 7 Ahmed el Zayat
City Postal code Country Position/Affiliation
Giza 12613 Egypt assistant professor of physical therapy
REPORTING
Share IPD Description Additional Document Types Sharing Time Frame Key Access Criteria
Yes Patients diagnosed as mechanical LBP due to myogenic cause - Patient will has active trigger point at least two points in each muscle (erectrospinae ,quadratus lambourum , gluteus medius and hamstring ) patient age ranged from 20 -40 Study Protocol Patients diagnosed as mechanical LBP due to myogenic cause - Patient will has active trigger point at least two points in each muscle (erectrospinae ,quadratus lambourum , gluteus medius and hamstring ) patient age ranged from 20 -40 Patients diagnosed as mechanical LBP due to myogenic cause - Patient will has active trigger point at least two points in each muscle (erectrospinae ,quadratus lambourum , gluteus medius and hamstring ) patient age ranged from 20 -40
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