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.: PACTR202007743553152 Date of Approval: 13/07/2020
Trial Status: Retrospective registration - This trial was registered after enrolment of the first participant
TRIAL DESCRIPTION
Public title Effect of seated break time periods on prolonged standing on low back pain
Official scientific title Effect of seated break time on prolonged standing low back pain developers
Brief summary describing the background and objectives of the trial Background: Pan American Health Organization cited low back pain as one of three occupational problems that should be under surveillance, despite a high prevalence of low back pain (LBP) development during prolonged standing. Objectives: To investigate the effect of seated break time on prolonged standing low back pain developers
Type of trial CCT
Acronym (If the trial has an acronym then please provide)
Disease(s) or condition(s) being studied Injury, Occupational Diseases, Poisoning,Musculoskeletal Diseases,Orthopaedics
Sub-Disease(s) or condition(s) being studied
Purpose of the trial one shot study
Anticipated trial start date 01/11/2018
Actual trial start date 08/10/2019
Anticipated date of last follow up 08/12/2019
Actual Last follow-up date 30/12/2019
Anticipated target sample size (number of participants) 60
Actual target sample size (number of participants) 60
Recruitment status Completed
Publication URL
Secondary Ids Issuing authority/Trial register
P.T.REC 012002091 Research ethics committee faculty of physical therapy Cairo university
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 Care giver/Provider
INTERVENTIONS
Intervention type Intervention name Dose Duration Intervention description Group size Nature of control
Control Group stand 15 min. and take rest of sitting bouts for 5 min. 30 workers from ABB ARAB factory only males used (they will stand 15 min. and take rest of sitting bouts for 5 min. throughout the workday) by ratio 3:1. throughout the workday for one day 30 workers from ABB ARAB factory only males used (they will stand 15 min. and take rest of sitting bouts for 5 min. throughout the workday) by ratio 3:1. 30 Dose Comparison
Experimental Group sitting for 10 min. every 30 min. of standing. 30 workers (males only) from ABB ARAB factory will take bouts of sitting for 10 min. every 30 min. of standing.by ratio 3:1 throughout the workday for one day 30 workers (males only) from ABB ARAB factory will take bouts of sitting for 10 min. every 30 min. of standing throughout the workday by ratio 3:1 30
ELIGIBILITY CRITERIA
List inclusion criteria List exclusion criteria Age Category Minimum age Maximum age Gender
The subjects were screened to ensure that they met the criteria documented in the study which include the following: 1. Age from 20 to 35 years old (15). 2. The working period from 1 to 5 years. 3. All subjects are pain developers 4. Normal upper extremity structure (based on general observation of the upper limb). 5. Full ROM in all upper limb joints (assessed by asking the patient to complete the expected range of movement of the upper limb as part of screening). 6. Adequate strength in the upper limb. 7. Unimpaired sensation. 8. Intact coordination. 9. males only 1. not having prior low back injuries that required a visit to a medical doctor or to miss more than three days of work 2. the inability to stand for two hours. 3. previous lumbar/hip surgery or work in an occupation that required prolonged static standing within the last 12 months 4. Individuals with any or pervious lower extremity injury 5. Severe kyphosis, scoliosis or spinal stenosis 6. History of spinal surgery in the previous 3 months 7. Scheduled for surgery 8. History of more than one surgical procedure on the spine 9. Cancer 10. Rheumatoid Arthritis 11. Ankylosing Spondylitis, spondylolisthesis 12. . Neurological disease other than nerve root involvement at the spinal level. 13. Inability to stand and walk without the use of walking aid 14. Patients who had LBP for 12 weeks or more that were admitted to the pain clinic and enrolled in a pain management program for CLBP. Adult: 19 Year-44 Year 20 Year(s) 35 Year(s) Male
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 09/09/2018 Faculty of physical therapy Cairo university
Ethics Committee Address
Street address City Postal code Country
7 ahmed elziat st. bein srayyat giza ,Egypt Cairo 11411 Egypt
OUTCOMES
Type of outcome Outcome Timepoint(s) at which outcome measured
Primary Outcome The visual analogue scale was used to assess pain and BROM (back range of motion device) was used to assess the range of motion of the lumbar and thoracic spine. before and after intervention
Secondary Outcome 1. The visual analogue scale was used to assess pain. 2. BROM (back range of motion device) was used to assess the range of motion of the lumbar and thoracic spine. before and after intervention
RECRUITMENT CENTRES
Name of recruitment centre Street address City Postal code Country
ABB ARAB factory zone 7 industry area 10th of Ramadan district sharkia 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
Secondary Sponsor ABB ARAB factory zone 7 industry area 10th of Ramadan district sharkia Egypt provide us with workers
COLLABORATORS
Name Street address City Postal code Country
CONTACT PEOPLE
Role Name Email Phone Street address
Principal Investigator Mohamed Mostafa drsergany_79@hotmail.com 00201020921809 77 shalhoub street ahmed essmat ain shams
City Postal code Country Position/Affiliation
Cairo 11311 Egypt Associate professor department of basic science faculty of physical therapy Cairo university
Role Name Email Phone Street address
Public Enquiries Nabil AbdelAall nabil_45@hotmail.com 00201200133613 7Ahmed elzyat street bein srayat .Giza .Egypt
City Postal code Country Position/Affiliation
Cairo Egypt Lecturer of Physical Therapy Basic Sciences department Faculty of Physical Therapy Cairo University.
Role Name Email Phone Street address
Scientific Enquiries Mohamed Mostafa drsergany_79@hotmail.com 00201020921809 77 shalhoub street ahmed essmat ain shams
City Postal code Country Position/Affiliation
Cairo 11311 Egypt Associate professor department of basic science faculty of physical therapy Cairo university
REPORTING
Share IPD Description Additional Document Types Sharing Time Frame Key Access Criteria
Yes Individual Participant Data summary of results Study Protocol 5 month period of time after publication Controlling access to data
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