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.: PACTR202208887892516 Date of Approval: 25/08/2022
Trial Status: Retrospective registration - This trial was registered after enrolment of the first participant
TRIAL DESCRIPTION
Public title EFFICACY AND COST-EFFECTIVENESS OF A CLINIC-BASED AND TWO DIGITAL APPLICATIONS OF MCKENZIE THERAPY IN LONG-TERM LOW-BACK PAIN
Official scientific title EFFICACY AND COST-EFFECTIVENESS OF A CLINIC-BASED AND TWO DIGITAL APPLICATIONS OF MCKENZIE THERAPY IN LONG-TERM LOW-BACK PAIN
Brief summary describing the background and objectives of the trial This study evaluated the effectiveness of a clinic-based McKenzie therapy on pain, disability, psychosocial outcome and general health status in patients with long-term Low-Back Pain; assessed the effectiveness of a mobile-phone based McKenzie therapy; investigated the effectiveness of a virtual-reality based McKenzie therapy in these patients; and compared the efficacy and cost-effectiveness of mobile-app and virtual reality modes relative to CBMT in patients with long-term Low-Back Pain
Type of trial RCT
Acronym (If the trial has an acronym then please provide) RCT
Disease(s) or condition(s) being studied Musculoskeletal Diseases
Sub-Disease(s) or condition(s) being studied
Purpose of the trial Rehabilitation
Anticipated trial start date 05/11/2019
Actual trial start date 05/11/2019
Anticipated date of last follow up 03/02/2020
Actual Last follow-up date 03/02/2020
Anticipated target sample size (number of participants) 120
Actual target sample size (number of participants) 120
Recruitment status Completed
Publication URL https://ir.oauife.edu.ng/handle/123456789/7503
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 Masking/blinding used Outcome Assessors
INTERVENTIONS
Intervention type Intervention name Dose Duration Intervention description Group size Nature of control
Control Group Clinic based McKenzie therapy Three times a week Eight weeks The participants received standard McKenzie extension protocol. The protocol involves a course of specific lumbosacral repeated movements in extension that cause the symptoms to centralize, decrease, or abolish. The extension activities include Extension Lying Prone, Extension in Prone, and Extension in Standing, repeated up to ten times. 43 Active-Treatment of Control Group
Experimental Group Telerehabilitation based McKenzie therapy Thrice weekly Eight weeks Telerehabilitation-based McKenzie therapy is a comparable version of CBMT performed in the home with the assistance of a mobile phone app. The TBMT app is a combination of the McKenzie extension protocols and back care education developed and enabled to run on a smartphone or android phone with Operating System of 3.0. 36
Experimental Group Virtual reality based McKenzie therapy Thrice weekly Eight weeks The virtual reality tasks developed and conducted on a Microsoft’s Kinect platform. The choice of tasks in the virtual reality is comparable with the McKenzie extension protocol, as well as relevant in rehabilitation of low back pain. 41
ELIGIBILITY CRITERIA
List inclusion criteria List exclusion criteria Age Category Minimum age Maximum age Gender
Patients with Long term mechanical low back pain refers to back pain lasting not less than 3 months, of musculoskeletal origin, and with symptoms varying with physical activity. The standard McKenzie Institute Lumbar Spine Assessment Algorithm (MILSAA) was used to determine eligibility for participation. Patients with positive history of red flags indicative of serious spinal pathology (i.e. those with complaints of dermatomal sensory loss, myotomal muscle weakness, and reduced lower limb reflexes). Patients with any obvious spinal deformity or neurological disease. Patients with pregnancy or previous spinal surgery. Patients with previous experience of MDT extension protocol and underlying systemic or visceral disease or specific condition such as dementia, cognitive dysfunction, visual impairment, history of epilepsy. Adult: 19 Year-44 Year,Middle Aged: 45 Year(s)-64 Year(s) 19 Year(s) 64 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 05/11/2019 Health Research Ethic Committee
Ethics Committee Address
Street address City Postal code Country
Obafemi Awolowo University, Ile-Ife Osogbo 220232 Nigeria
OUTCOMES
Type of outcome Outcome Timepoint(s) at which outcome measured
Primary Outcome Pain Intensity Baseline, 4th week, 8th week
Secondary Outcome Back Extension Muscles’ Endurance, Activity Limitation, Participation Restriction, Fear Avoidance Belief, Kinesiophobi, and General Health Status. Baseline, 4th week and 8th week
RECRUITMENT CENTRES
Name of recruitment centre Street address City Postal code Country
Obafemi Awolowo University Department of Medical Rehabilitation, College of Health Sciences, Obafemi Awolowo University Osogbo 220232 Nigeria
FUNDING SOURCES
Name of source Street address City Postal code Country
Chidozie Mbada Department of Medical Rehabilitation, College of Health Sciences, Obafemi Awolowo University Osogbo 220232 Nigeria
SPONSORS
Sponsor level Name Street address City Postal code Country Nature of sponsor
Primary Sponsor Chidozie Mbada Department of Medical Rehabilitation, College of Health Sciences, Obafemi Awolowo University Osogbo 220232 Nigeria Individual
COLLABORATORS
Name Street address City Postal code Country
CONTACT PEOPLE
Role Name Email Phone Street address
Principal Investigator Chidozie Mbada cembada@oauife.edu.ng +2348028252543 Department of Medical Rehabilitation, College of Health Sciences, Obafemi Awolowo University
City Postal code Country Position/Affiliation
Osogbo 220232 Nigeria Senior Lecturer
Role Name Email Phone Street address
Public Enquiries Laminde Maikudi maikudilami@gmail.com 07032879862 Department of Medical Rehabilitation, College of Health Sciences, Obafemi Awolowo University
City Postal code Country Position/Affiliation
Osogbo 220232 Nigeria Clinician
Role Name Email Phone Street address
Scientific Enquiries Laminde Maikuidi maikudilami@gmail.com 07032879862 Department of Medical Rehabilitation, College of Health Sciences, Obafemi Awolowo University
City Postal code Country Position/Affiliation
Osogbo 220232 Nigeria Clinician
REPORTING
Share IPD Description Additional Document Types Sharing Time Frame Key Access Criteria
Yes Individual participant data will be made available. Individual participant data that underline the results reported in this article, after deidentification (text, tables, figures and appendices) will be shared. Statistical Analysis Plan,Study Protocol Immediately following publication. No end date. Researchers who provide a methodological sound proposal to achieve aims in the research proposal
URL Results Available Results Summary Result Posting Date First Journal Publication Date
https://ir.oauife.edu.ng/handle/123456789/7503 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