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.: PACTR201707002001797 Date of Approval: 29/01/2017
Trial Status: Retrospective registration - This trial was registered after enrolment of the first participant
TRIAL DESCRIPTION
Public title Comparison of stratified care approaches (STart Back & STOPS) among individuals with non-specific Low back pain
Official scientific title Comparative effect of stratified Back care approaches (STarT Back & STOPS) among individuals with non-specific Low back pain
Brief summary describing the background and objectives of the trial The main aim of the study was to investigate the effects of stratified care approaches i.e STarT Back and STOPS approaches among individuals with non-specific Low Back pain, also to compare the clinical out comes of the two interventions after 8 weeks.
Type of trial RCT
Acronym (If the trial has an acronym then please provide)
Disease(s) or condition(s) being studied Non-specific Low back pain,Orthopaedics
Sub-Disease(s) or condition(s) being studied
Purpose of the trial Treatment: Other
Anticipated trial start date 01/05/2016
Actual trial start date 06/05/2016
Anticipated date of last follow up 12/08/2016
Actual Last follow-up date 31/08/2016
Anticipated target sample size (number of participants) 46
Actual target sample size (number of participants) 41
Recruitment status Completed
Publication URL
Secondary Ids Issuing authority/Trial register
NHREC/21/08/2008/AKTH/EC/1725
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 Patients were randomly assigned to groups by Toss of a coin Independent assessors were blinded to the treatment group of the patients and the intervention they received. Allocation was by toss of a coin Masking/blinding used Outcome Assessors
INTERVENTIONS
Intervention type Intervention name Dose Duration Intervention description Group size Nature of control
Experimental Group STarT Protocol twice per week 8 weeks Low risk group - Only advise, Medium risk - Encourage self-management for patients coupled with stabilization exercises. High risk - combined aerobic and stabilization exercises as well as cognitive behavioral therapy 23 Active-Treatment of Control Group
Control Group STOPs Protocol twice per week 8 weeks Exercise, advice to remain active and instruction on postural correction strategies as determined by the screening tool. 23 Active-Treatment of Control Group
ELIGIBILITY CRITERIA
List inclusion criteria List exclusion criteria Age Category Minimum age Maximum age Gender
-Participants who signed informed consent form. -Participants who are not receiving any other form of LBP treatment during this study -Participants diagnosed with NSLBP -Participants who are between ages of 18-60 years during the period of this study -Pregnancy -Individuals who had LBP surgery -Individuals with potentially serious disorders such as systemic or neo-plastic disease -Individuals with comorbidity (having neck pain, back pain or knee OA in addition to back pain) were also excluded 18 Year(s) 60 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 27/07/2016 Aminu kano Teaching Hospital
Ethics Committee Address
Street address City Postal code Country
Zaria Road kano 234777 Nigeria
OUTCOMES
Type of outcome Outcome Timepoint(s) at which outcome measured
Primary Outcome Pain and functinal disability Baseline, 4 weeks and 8 weeks
RECRUITMENT CENTRES
Name of recruitment centre Street address City Postal code Country
Dawakin Tofa General Hospital aminu Nigeria
physiotherapy Department of Aminu Kano Teaching Hospital Zaria Road Kano Kano 3452 Nigeria
FUNDING SOURCES
Name of source Street address City Postal code Country
self sponsored
SPONSORS
Sponsor level Name Street address City Postal code Country Nature of sponsor
Secondary Sponsor Aminu kano Teaching hospital Kano Zaria Road Kano Kano 3452 Nigeria University
Primary Sponsor Muhyiddeen S. Bichi No 240 Giginyu B Kano 234777 Nigeria University
COLLABORATORS
Name Street address City Postal code Country
Dr. Bashir Bello No 1 Zaria Road, Kano Kano 234777 Nigeria
CONTACT PEOPLE
Role Name Email Phone Street address
Principal Investigator Muhyiddeen Bichi msbichi@gmail.com 2348035943290 No. 240 Giginyu B, Nassarawa Kano
City Postal code Country Position/Affiliation
Kano Nil Nigeria Msc. Student/Bayero University, Kano
Role Name Email Phone Street address
Public Enquiries Abubakar Mahmud inquiry@akth.org.ng 2347068297399 No. 1 Zaria Road Kano
City Postal code Country Position/Affiliation
Kano 234777 Nigeria Secretary Ethics Committee AKTH
Role Name Email Phone Street address
Scientific Enquiries Bashir Bello nurubash@gmail.com 08037019137 Zaria Road Kano
City Postal code Country Position/Affiliation
Kano Nigeria Senior Lecturer/ Bayero University, Kano
REPORTING
Share IPD Description Additional Document Types Sharing Time Frame Key Access Criteria
URL Results Available Results Summary Result Posting Date First Journal Publication Date
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