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.: PACTR202109917007872 Date of Approval: 08/09/2021
Trial Status: Retrospective registration - This trial was registered after enrolment of the first participant
TRIAL DESCRIPTION
Public title COMPARATIVE EFFICACY OF CLINIC-BASED AND TELEREHABILITATION APPLICATION OF MCKENZIE THERAPY IN CHRONIC LOW-BACK PAIN
Official scientific title COMPARATIVE EFFICACY OF CLINIC-BASED AND TELEREHABILITATION APPLICATION OF MCKENZIE THERAPY IN CHRONIC LOW-BACK PAIN
Brief summary describing the background and objectives of the trial This study compared the effects of Telerehabilitation-Based McKenzie Therapy (TBMT) and Clinic-Based McKenzie Therapy (CBMT) among patients with 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 04/11/2019
Actual trial start date 11/11/2019
Anticipated date of last follow up 10/03/2020
Actual Last follow-up date 19/03/2020
Anticipated target sample size (number of participants) 47
Actual target sample size (number of participants) 47
Recruitment status Completed
Publication URL https://www.researchgate.net/publication/333759927_COMPARATIVE_EFFICACY_OF_CLINIC-BASED_AND_TELEREHABILITATION_APPLICATION_OF_MCKENZIE_THERAPY_IN_CHRONIC_LOW-BACK_PAIN
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 Permuted block randomization Sealed opaque envelopes Masking/blinding used Care giver/Provider
INTERVENTIONS
Intervention type Intervention name Dose Duration Intervention description Group size Nature of control
Control Group Clinic Based McKenzie Therapy Thrice weekly Eight weeks The Clinic-Based McKenzie Therapy group received the McKenzie extension protocol involving a course of specific lumbosacral repeated movements in extension that cause the symptoms to centralize, decrease, or abolish and a set of back care education instructions comprised of a 9-item instructional guide on standing, sitting, lifting, and other activities of daily living for home. 26 Active-Treatment of Control Group
Experimental Group Telerehabilitation Based McKenzie Therapy Three times a week Eight weeks Telerehabilitation-based McKenzie therapy is a comparable version of Clinic based McKenzie Therapy performed in the home with the assistance of a mobile phone app. It is an app of 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. 21
ELIGIBILITY CRITERIA
List inclusion criteria List exclusion criteria Age Category Minimum age Maximum age Gender
Patients with clinical diagnosis of chronic nonspecific LBP who were between the ages of 20 and 65 years. Patients without any obvious deformities affecting the trunk or upper and lower extremities. Patients with known co-morbidity or reported history of cardiovascular disease contraindicating exercise. Patients being pregnant. Patients with previous back surgery. Patients with previous experience of the McKenzie therapy. Patients having directional preference for flexion or no directional preference based on the McKenzie Assessment. Adult: 19 Year-44 Year,Middle Aged: 45 Year(s)-64 Year(s) 20 Year(s) 65 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 05/11/2020 Health research ethic committee
Ethics Committee Address
Street address City Postal code Country
Institute of public health, Obafemi Awolowo University Osogbo 220282 Nigeria
OUTCOMES
Type of outcome Outcome Timepoint(s) at which outcome measured
Primary Outcome Pain Intensity 4th and 8th week
Secondary Outcome Back Extensors Muscles’ Endurance, Activity Limitation, Participation Restriction and General Health Status 4th 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 220282 Nigeria
FUNDING SOURCES
Name of source Street address City Postal code Country
Maikudi Laminde Department of Medical rehabilitation, college of health sciences, Obafemi Awolowo University Osogbo 220282 Nigeria
SPONSORS
Sponsor level Name Street address City Postal code Country Nature of sponsor
Primary Sponsor Maikudi Laminde Department of Medical rehabilitation, college of health sciences, Obafemi Awolowo University Osogbo 220282 Nigeria Individual
COLLABORATORS
Name Street address City Postal code Country
CONTACT PEOPLE
Role Name Email Phone Street address
Principal Investigator Chidozie Mbada doziembada@yahoo.com +2348028252543 Department of Medical rehabilitation, college of health sciences, Obafemi Awolowo University
City Postal code Country Position/Affiliation
Osogbo 220282 Nigeria Researcher
Role Name Email Phone Street address
Public Enquiries Chidozie Mbada doziembada@yahoo.com +2348028252543 Department of Medical rehabilitation, college of health sciences, Obafemi Awolowo University
City Postal code Country Position/Affiliation
Osogbo 220282 Nigeria Researcher
Role Name Email Phone Street address
Scientific Enquiries Chidozie Mbada doziembada@yahoo.com +2348028252543 Department of Medical rehabilitation, college of health sciences, Obafemi Awolowo University
City Postal code Country Position/Affiliation
Osogbo 220282 Nigeria Researcher
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 underlie the results reported in this article, after deidentification (texts, 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://www.researchgate.net/publication/333759927_COMPARATIVE_EFFICACY_OF_CLINIC-BASED_AND_TELEREHABILITATION_APPLICATION_OF_MCKENZIE_THERAPY_IN_CHRONIC_LOW-BACK_PAIN 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