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.: PACTR202007597569823 Date of Approval: 01/07/2020
Trial Status: Registered in accordance with WHO and ICMJE standards
TRIAL DESCRIPTION
Public title Effect of an educational program on the perception of pain on function after lumbar spinal surgery
Official scientific title Effect of an educational program on the perception of pain on function after lumbar spinal surgery
Brief summary describing the background and objectives of the trial Purpose on the study is to establish an effect of an educational program on the perception of pain on function after lumbar spinal surgery. It is an experimental design using a prospective single blinded randomized control trial to be explored. Data collection sheet, Keele STarT Back Screening Tool and Pain Catastrophizing scare questionnaires will be used. A 12 weeks intervention in the form of pain education videos will be given to experimental group after surgery.
Type of trial RCT
Acronym (If the trial has an acronym then please provide)
Disease(s) or condition(s) being studied Musculoskeletal Diseases,Orthopaedics
Sub-Disease(s) or condition(s) being studied
Purpose of the trial Education /Training
Anticipated trial start date 01/07/2020
Actual trial start date
Anticipated date of last follow up 23/09/2020
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
880 2019 University of Pretoria Research Ethics Committee
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 Masking/blinding used Outcome Assessors,Participants
INTERVENTIONS
Intervention type Intervention name Dose Duration Intervention description Group size Nature of control
Experimental Group Education Different video every second week after lumbar spinal surgery for twelve weeks twelve weeks Education videos on the patterns of pain and avoiding the fear of movement after lumbar spinal surgery 30
Control Group Control group no intervention. Only standard physiotherapy treatment as with experimental group 12 weeks study questionnaires mearsurements 30 Active-Treatment of Control Group
ELIGIBILITY CRITERIA
List inclusion criteria List exclusion criteria Age Category Minimum age Maximum age Gender
patient undergoing lumbar spinal surgery and have consented to study participation. patients above age of 18 patient undergoing lumbar spinal surgery for fractures and tumor removals. patients under age of 18 80 and over: 80+ Year,Adolescent: 13 Year-18 Year,Adult: 19 Year-44 Year,Aged: 65+ Year(s),Middle Aged: 45 Year(s)-64 Year(s) 18 Year(s) 85 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 16/03/2020 University of Pretoria Research Ethics Committee. Faculty of Health Sciences
Ethics Committee Address
Street address City Postal code Country
Room 4-60 Gezina 0031 South Africa
OUTCOMES
Type of outcome Outcome Timepoint(s) at which outcome measured
Primary Outcome Aims is to establish an effect of educational program on the perception of pain on function after lumbar spinal surgery. This will be achieved through determining extend of the perceived pain and disability before and after lumbar spinal surgery, determining the relationship between extent of pain perceived on function before and after surgery and ultimately determining perception of pain on function in control group versus experimental group. Before lumbar spinal surgery, after surgery and every two weeks for twelve weeks
Secondary Outcome This will be achieved through determining extend of the perceived pain and disability before and after lumbar spinal surgery, determining the relationship between extent of pain perceived on function before and after surgery and ultimately determining perception of pain on function in control group versus experimental group. This will be determined at end of the 12 weeks intervention
RECRUITMENT CENTRES
Name of recruitment centre Street address City Postal code Country
Kloofmediclinic 511 Jochemus Pretoria Erusmuskloof 0081 South Africa
FUNDING SOURCES
Name of source Street address City Postal code Country
Kgabo Dan Masoma 2797 Stand RosslynX46 Southern cross str Akasia Pretoria 0182 South Africa
SPONSORS
Sponsor level Name Street address City Postal code Country Nature of sponsor
Primary Sponsor Kgabo Masoma self Southern Cross Rosslyn 0182 South Africa Individual
COLLABORATORS
Name Street address City Postal code Country
Dr Nombeko Mshunqane and Miss Nontembiso Magida University of Pretoria Faculty of Health Sciences. Room 3-75.10 level 3 HW Snyman Building Gezina 0031 South Africa
CONTACT PEOPLE
Role Name Email Phone Street address
Principal Investigator Kgabo Masoma kgabza911@gmail.com 0736548734 Southern cross street
City Postal code Country Position/Affiliation
Rosslyn 0182 South Africa Masters student
Role Name Email Phone Street address
Public Enquiries Nombeko Mshunqane nombeko.mshunqane@up.ac.za +27123563235 Room 3-75.10, level 3 HW Snyman Building
City Postal code Country Position/Affiliation
Gezina 0031 South Africa Research Supervisor
Role Name Email Phone Street address
Scientific Enquiries Nontembiso Magida nontembiso.magida@up.ac.za 0829638547 Room 3-75.4, HW Snyman building
City Postal code Country Position/Affiliation
Gezina Pretoria 0031 South Africa Research supervisor
REPORTING
Share IPD Description Additional Document Types Sharing Time Frame Key Access Criteria
Yes The study results will be disseminated. upon request a protocol can be shared as well. Study Protocol Within 12 months of completion. PACTR
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