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.: PACTR202105581994227 Date of Approval: 07/05/2021
Trial Status: Retrospective registration - This trial was registered after enrolment of the first participant
TRIAL DESCRIPTION
Public title Effects of McKenzie, Stabilization,and Combined McKenzie and Stabilization Protocols on Clinical and Psycho-social Variables in individuals with Chronic Mechanical Low Back Pain.
Official scientific title Effects of McKenzie, Stabilization,and Combined McKenzie and Stabilization Protocols on Clinical and Psycho-social Variables in individuals with Chronic Mechanical Low Back Pain.
Brief summary describing the background and objectives of the trial Chronic Mechanical Low Back Pain is a universal health problem affecting more than 80% of a given population, with the attending or associated psycho-social challenges. Different types of exercises have being used for the condition,with less convincing outcome or effectiveness. McKenzie and Stabilization exercises have been proven to be effective in Acute and Sub-acute mechanical Low Back Pain,but the effects on Chronic Low Back Pain is sparsely documented. This study is aimed at finding the effects of each, and combination of the two exercises on individuals presenting with this often debilitating health condition.
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 Rehabilitation
Anticipated trial start date 11/07/2019
Actual trial start date 12/07/2019
Anticipated date of last follow up 10/07/2020
Actual Last follow-up date 15/01/2020
Anticipated target sample size (number of participants) 141
Actual target sample size (number of participants) 143
Recruitment status Completed
Publication URL
Secondary Ids Issuing authority/Trial register
UI EC 17 0076 Institute For Advanced Medical Research And Training, Collrge of Medicine, University of Ibadan, Ibadan. Nigeria.
LTH OGB EC 2016 135 Ethical Committee, LAUTECH Teaching Hospital, Ogbomoso, Oyo State. Nigeria.
LTH EC 2017 07 328 Research Ethics Committee, Ladoke Akintola University of Technology Teaching Hospital, Osogbo, Osun State. Nigeria.
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 Non-randomised Allocation was determined by the holder of the sequence who is situated off site Open-label(Masking Not Used)
INTERVENTIONS
Intervention type Intervention name Dose Duration Intervention description Group size Nature of control
Experimental Group McKenzie Exercise 30 minutes treatment exercise,twice a week for eight weeks duration At least 30 minutes per session. 10 minutes warm up exercise,followed by about 20-25 minutes exercise and cool down period. The exercise consists of the 5 stages of the McKenzie exercises as a progression, or the 3 stages of Stabilization as a progression from one stage to another, or each of the 5 stages of McKenzie exercise follow by the 3 stages of Stabilization exercise (Combined exercise group) for each of the 8 weeks therapeutic exercise period. 47
Experimental Group Stabilization exercise Twice per week 8 weeks 10 minutes low intensity warm up exercise made up of 3 minutes walk around research venue at self determined pace, 2 minutes free active shoulder abduction and flexion exercises, and 5 minutes free loaded bicycle ergometry. 47
Control Group Combined exercise Twice per week 8 weeks 10 minutes warm up made up of 3 minutes walk around research venue at self determined pace,2 minutes repeated free active shoulder flexion and abduction, and 5 minutes free loaded bicycle ergometry. 48 Active-Treatment of Control Group
ELIGIBILITY CRITERIA
List inclusion criteria List exclusion criteria Age Category Minimum age Maximum age Gender
Chronic mechanical low back pain of at least 3 months duration. Posterior derangement using McKenzie Institute Lumbar spine Screening Form Red flags in Low back pain Uncontrolled blood pressure Pregnancy Spinal surgery Pheriperilization of symptoms with repeated spinal extension or McKenzie Institute Screening Form Anterior derangement, lateral derangement, or no derangement with McKenzie screening 80 and over: 80+ Year,Adult: 19 Year-44 Year,Aged: 65+ Year(s),Middle Aged: 45 Year(s)-64 Year(s) 19 Year(s) 80 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 11/07/2019 University of Ibadan ETHICS COMMITTEE
Ethics Committee Address
Street address City Postal code Country
College of Medicine University of Ibadan Ibadan 20001 Nigeria
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 05/01/2017 Ladoke Akintola University of Technology Teaching Hospital Ethical Committee
Ethics Committee Address
Street address City Postal code Country
LAUTECH Teaching Hospital Ogbomoso 20003 Nigeria
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 25/07/2017 Research Ethics Committee Ladoke Akintola University of Technology Teaching Hospital
Ethics Committee Address
Street address City Postal code Country
Station Road Osogbo 230001 Nigeria
OUTCOMES
Type of outcome Outcome Timepoint(s) at which outcome measured
Primary Outcome Quadruple Visual Analogue Scale, Oswestry Disability Questionnaire, and Fear Avoidance Belief Questionnaire. At baseline, at 4th week of treatment, and at 8th week of treatment.
Secondary Outcome Pain intensity, Functional Disability, and Fear Avoidance/activity restriction. At baseline, at 4th week of intervention, and at 8th week of intervention.
RECRUITMENT CENTRES
Name of recruitment centre Street address City Postal code Country
LAUTECH Teaching Hospital Station Road Osogbo 23001 Nigeria
State Specialist Hospital Asubiaro Osogbo 23001 Nigeria
LAUTECH Teaching Hospital Ilorin - Ogbomoso Expressway Ogbomoso Nigeria
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 NUDAMAJO OLUWASEGUN Sunday Physiotherapy Department,State Hospital Ogbomoso Nigeria Individual
COLLABORATORS
Name Street address City Postal code Country
CONTACT PEOPLE
Role Name Email Phone Street address
Principal Investigator NUDAMAJO OLUWASEGUN Sunday segun_nuda@yahoo.com +2348035261430 Ilorin-Ogbomoso Expressway
City Postal code Country Position/Affiliation
Ogbomoso Nigeria Deputy Director of Physiotherapy
Role Name Email Phone Street address
Public Enquiries Ayanniyi Olusola Mckdalos@yahoo.com +2348033830601 Physiotherapy Department, College of Medicine, University of Ibadan
City Postal code Country Position/Affiliation
Ibadan 20001 Nigeria Associate Professor
Role Name Email Phone Street address
Scientific Enquiries NUDAMAJO OLUWASEGUN SUNDAY segunnuda@gmail.com +2348127020463 Physiotherapy Department,State Hospital
City Postal code Country Position/Affiliation
Ogbomoso 210214 Nigeria Researcher
REPORTING
Share IPD Description Additional Document Types Sharing Time Frame Key Access Criteria
Yes All of the Individual Patients Data that underlies the results of the study will be available after deidentification of individual participants. Analytic Code,Statistical Analysis Plan,Study Protocol Immediately after publication of the results of the research study Anyone who wishes to access the study, especially for research purposes with good methodological proposal.
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