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.: PACTR202004688676622 Date of Approval: 24/04/2020
Trial Status: Registered in accordance with WHO and ICMJE standards
TRIAL DESCRIPTION
Public title Effect of Maitland Mobilization on Lumbar Proprioception in Chronic Non-specific Low Back Pain Patients (randomized controlled trial)
Official scientific title Effect of Maitland Mobilization on Lumbar Proprioception in Chronic Non-specific Low Back Pain Patients
Brief summary describing the background and objectives of the trial proprioception deficits and decrease in ROM and slowed movement in patients with LBP compared with normal counterparts.Maitland Poster-anterior spinal mobilization is one of most common used manual therapy. Maitland P A restores spinal mobility and decrease spinal stiffness . Maitland Poster-anterior passive mobilization technique restores the normal mechanics and improves muscular function, mobility, and flexibility, as well as psychological response .study will be conducted to determine the effect of maitland mobilization on pain ,function ,lumbar proprioception,lumbar curvature and under whole effect of maitland on chronic non specific low back pain .
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: Other
Anticipated trial start date 22/03/2020
Actual trial start date 22/03/2020
Anticipated date of last follow up 25/04/2021
Actual Last follow-up date 25/04/2021
Anticipated target sample size (number of participants) 40
Actual target sample size (number of participants) 40
Recruitment status 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 Central randomisation by phone/fax Masking/blinding used Participants
INTERVENTIONS
Intervention type Intervention name Dose Duration Intervention description Group size Nature of control
Experimental Group Maitland mobilization 3seession per week One month Control group recieves strech ,strength and stabilization exercises Experimental group receives Maitland in addition to treatment of control 20
Control Group Convential physical therapy 3 times per week 4 weeks Stretch, strength and stabilization exercises 20 Active-Treatment of Control Group
ELIGIBILITY CRITERIA
List inclusion criteria List exclusion criteria Age Category Minimum age Maximum age Gender
Inclusive criteria - The patient’s age from18–45 years (Candotti et al., 2015). - Both sex patients, their body mass index is less than 30K/M 2 - Pain in the lumbar and/or buttock region (defined as pain reported below the level of T12 and no lowers than the buttock line). - The patients have at least 3 months of continuous or intermittent LBP symptoms. -Signs of serious spinal pathology (red flags) including significant trauma, unexplained weight loss and widespread neurologic changes (Georgy, 2011). -Any vestibular, visual problems and current inner ear infection affecting balance. (Georgy, 2011) -Current radiating symptoms (and/or neurological deficit) below the level of the buttock crease. -Current pregnancy or obese. -History of spinal fracture and malignancy -Specific LBP, defined as herniated disc, ankylosing spondylitis, spondylolisthesis. -Patients had any contraindication to physiotherapy and manual therapy(Dutton, 2002). -Patients with any spinal operation, pathology and lower limb problems. -Patients with congenital postural deformities (Georgy, 2011). Adult: 19 Year-44 Year 18 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 22/03/2020 Faculty of physical therapy ethics research
Ethics Committee Address
Street address City Postal code Country
7Ahmed El Zayad street, Dooki, Giza, Egypt Giza 12613 Egypt
OUTCOMES
Type of outcome Outcome Timepoint(s) at which outcome measured
Primary Outcome Measurement of lumbar proprioception by active repositioning by isokinetic dynamometer Before and after 4 weeks
Secondary Outcome Pain, function and lumbar curvature Before and after 4 weeks
RECRUITMENT CENTRES
Name of recruitment centre Street address City Postal code Country
Outpatient clinic of faculty of physical therapy 7Ahmed El Zayad street, Dooki, Giza, Egypt Giza Egypt
FUNDING SOURCES
Name of source Street address City Postal code Country
SPONSORS
Sponsor level Name Street address City Postal code Country Nature of sponsor
Primary Sponsor Cairo university 1 Gamaa Street, Giza Giza 12613 Egypt University
COLLABORATORS
Name Street address City Postal code Country
CONTACT PEOPLE
Role Name Email Phone Street address
Principal Investigator Adel Mohammed Adelmhmd4444@gmail.com 01126937665 15 A Mustafa Safwat st, Helwan, Cairo
City Postal code Country Position/Affiliation
Cairo Egypt Lecturer assistant at faculty of physical therapy Cairo university
Role Name Email Phone Street address
Public Enquiries Maher Elkabalwy MaherElkabalwy@yahoo.com 01001419544 1 games street
City Postal code Country Position/Affiliation
Giza Egypt Professor of Basic Science Department Faculty of Physical Therapy Cairo University
Role Name Email Phone Street address
Scientific Enquiries Ahmed Elerian Dr_ahmed_elerian77@yahoo.com 01116752333 16 Alnassr st, Elmaadi
City Postal code Country Position/Affiliation
Cairo Egypt Assistant professor of Basic Science Department Faculty of Physical Therapy Cairo University
Role Name Email Phone Street address
Scientific Enquiries Mariam Omran Mariamomran333@yahoo.com 01005541018 5 Ahmed elzayad st, dokii
City Postal code Country Position/Affiliation
Giza Egypt Lecturer of Basic Science Department Faculty of Physical Therapy Cairo University
REPORTING
Share IPD Description Additional Document Types Sharing Time Frame Key Access Criteria
Yes Age, pain, lumbar curvature ,lumbar proprioception Informed Consent Form,Statistical Analysis Plan,Study Protocol One year Open access
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