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.: PACTR202011636356540 Date of Registration: 16/11/2020
Trial Status: Retrospective registration - This trial was registered after enrolment of the first participant
TRIAL DESCRIPTION
Public title The combined effect of Maitland spinal mobilization with mechanical lumbar traction on patients with chronic non specific low back pain
Official scientific title The combined effect of Maitland spinal mobilization with mechanical lumbar traction on patients with chronic non specific low back pain
Brief summary describing the background and objectives of the trial Low back pain is one of the most prevalent health problems. Chronic non specific low back pain (CNSLBP) is the most common type of back pain and diagnosed when back pain has no specific pathology or disease. Numerous treatments have been used for CNSLBP two of them are posterior anterior mobilization ( Maitland spinal mobilization) and Mechanical lumbar traction.No clear evidence that investigate the combined effect of Maitland spinal mobilization with mechanical lumbar traction, so the purpose of this study to measure and investigate the combined effect of Maitland spinal mobilization with mechanical lumbar traction on patients with chronic non specific low back pain. The subjects of both genders with age ranging from 20 to 30 years old are randomly allocated to four groups A,B,C,D. Out comes measures will include: Range of motion will measure by inclinometer , pain intensity will measure by visual analog scale(VAS) and function will be quantified by Arabic version modified oswestry disability questionnaire ( MODQ ). The assessment will be done before and after treatment.
Type of trial RCT
Acronym (If the trial has an acronym then please provide) Acronym
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 26/03/2020
Actual trial start date
Anticipated date of last follow up 31/08/2020
Actual Last follow-up date
Anticipated target sample size (number of participants) 60
Actual target sample size (number of participants) 44
Recruitment status Completed
Publication URL URL will be added later
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 A 3 Sessions per week 4 weeks Group A: will receive posterior anterior mobilization with conventional physical therapy and advices. 15
Experimental Group Group B 3 sessions per week 4 weeks Group B: will receive mechanical lumbar traction with conventional physical therapy and advices. 15
Experimental Group Group C 3 sessions per week 4 weeks Group C: will receive posterior anterior mobilization with mechanical lumbar traction and conventional physical therapy and advices. 15
Control Group D 3 sessions per week 4 weeks Group D(control group) : will receive conventional physical therapy and Advices 15 Dose Comparison
ELIGIBILITY CRITERIA
List inclusion criteria List exclusion criteria Age Category Minimum age Maximum age Gender
Age from 20 to 30 years old. Body mass index not more than 30. Low back pain with a duration of at least 3 months ago. Diagnosed with non specific low back pain. Diabetic patients. Patient with any surgical procedures. Pregnant women. Un consciousness patient. History of epilepsy. Leg length discrepancy Patient with cognitive impairment. Adult: 19 Year-44 Year 20 Year(s) 30 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 30/12/2018 Faculty of physical therapy cairo university
Ethics Committee Address
Street address City Postal code Country
7 Ahmed El-zayat st - Ben Elsarayat Giza 11432 Egypt
OUTCOMES
Type of outcome Outcome Timepoint(s) at which outcome measured
Primary Outcome Range of motion Outcome measured pre and post treatment
Primary Outcome Function Pre and post treatment
Secondary Outcome Pain intensity Pre and post treatment
RECRUITMENT CENTRES
Name of recruitment centre Street address City Postal code Country
Outpatient clinic of Sohag Hospital Alaref st Sohag Egypt
FUNDING SOURCES
Name of source Street address City Postal code Country
Hamdy Hassan Sohag Sohag 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 st Giza 12613 Egypt University
COLLABORATORS
Name Street address City Postal code Country
Wadida Hassan Eldokki Giza Egypt
Yasser Anis Nassr Cairo Egypt
CONTACT PEOPLE
Role Name Email Phone Street address
Principal Investigator Hamdy Hassan drhamdy.elhawary.89@gmail.com 01143013877 Sohag
City Postal code Country Position/Affiliation
Sohag Egypt Researcher on master degree in faculty of physical therapy
Role Name Email Phone Street address
Public Enquiries Wadida Elsayed Prof.wadida@gmail.com 01001097571 Eldokki
City Postal code Country Position/Affiliation
Giza 11433 Egypt Professor of Basic science department faculty of physical therapy Cairo university
Role Name Email Phone Street address
Scientific Enquiries Yasser Anis dryasser.anis@gmail.com 01001743830 Nasr
City Postal code Country Position/Affiliation
Cairo 11511 Egypt Professor assistant of physical therapy Cairo university
REPORTING
Share IPD Description Additional Document Types Sharing Time Frame Key Access Criteria
Yes All of the individual participants data will be collected during the trial and after de-adentification Clinical Study Report,Study Protocol Immediately post publication no end date any one who wishes to access the data. For any purpose.
URL Results Available Results Summary Result Posting Date First Journal Publication Date
URL will be added later 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