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 0835 or +27 21 938 0967
Email: pactradmin@mrc.ac.za Website: pactr.samrc.ac.za
Trial no.: PACTR202007533977502 Date of Registration: 08/07/2020
Trial Status: Retrospective registration - This trial was registered after enrolment of the first participant
TRIAL DESCRIPTION
Public title COMPARATIVE EFFECTS OF CLINIC- AND VIRTUAL REALITY-BASED MCKENZIE EXTENSION THERAPY IN CHRONIC NON-SPECIFIC LOW-BACK PAIN
Official scientific title COMPARATIVE EFFECTS OF CLINIC- AND VIRTUAL REALITY-BASED MCKENZIE EXTENSION THERAPY IN CHRONIC NON-SPECIFIC LOW-BACK PAIN
Brief summary describing the background and objectives of the trial The study compared the influence of Clinic-Based McKenzie Therapy (CBMT) and a Virtual Reality Game (VRG) version on pain intensity, back extensor muscles endurance, activity limitation, participation restriction, fear avoidance belief, kinesiophobia, and general health status of patients with chronic non-specific low-back pain.
Type of trial RCT
Acronym (If the trial has an acronym then please provide)
Disease(s) or condition(s) being studied Musculoskeletal Diseases
Sub-Disease(s) or condition(s) being studied
Purpose of the trial Treatment: Devices
Anticipated trial start date 04/06/2017
Actual trial start date 11/09/2017
Anticipated date of last follow up 03/12/2017
Actual Last follow-up date 22/12/2017
Anticipated target sample size (number of participants) 46
Actual target sample size (number of participants) 46
Recruitment status Completed
Publication URL https://doi.org/10.5114/hm.2019.83998
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
Parallel: different groups receive different interventions at same time during study Randomised Permuted block randomization Sealed opaque envelopes Masking/blinding used Participants
INTERVENTIONS
Intervention type Intervention name Dose Duration Intervention description Group size Nature of control
Control Group Clinic Based McKenzie Therapy Three times in a week 8 weeks In standing, the participants were asked to stand upright with the feet slightly apart and to place their hands in the small of the back with the fingers pointing backwards. The participant then stretched the trunk backwards at the waist level as far as they could, using the hands as a fulcrum while keeping the knees straight. The movement was repeated up to 10 times. 22 Active-Treatment of Control Group
Experimental Group Back Extension Virtual Reality Game Therapy Three times in a week Eight weeks An interactive video game developed to be operational on the Microsoft Kinect Xbox, which allows for a less invasive 3-dimensional graphic environment on a computer screen, flat screen monitor, or projector screen. BE-VRG has virtual reality tasks developed and conducted on a Microsoft’s Kinect platform. The choice of tasks in the BE-VRG was based on the intention that they had to be comparable with the McKenzie extension protocol, as well as relevant in rehabilitation of LBP. Thus, a VRG involving heading of a projectile virtual soccer ball was developed. Each participant was asked to maintain an upright standing position with the feet, while holding the waist with both hands. Stretching the trunk, the subject was asked to head balls coming to them as seen on the screen. The intended therapeutic motion was extension of the spine while standing. However, side-glides of the spine to the left and also to the right were observed as accompanying motions in that position. The participants were instructed to head away virtual balls coming towards them while their feet were stationary but the trunk and head moved to accomplish the ball heading. 26
ELIGIBILITY CRITERIA
List inclusion criteria List exclusion criteria Age Category Minimum age Maximum age Gender
Patients with clinical diagnosis of long-term non-specific LBP Patients without any obvious deformities affecting the trunk or upper and lower extremities Patients that were able to respond to game instructions and commands Patients with serious spinal pathology (including fractures, tumours, and inflammatory diseases) or any obvious spinal deformity or neurological disease. A reported history of cardiovascular disease contra-indicated to exercise; or individuals who present with elevated blood pressure (>140/90mmHg). Patients who were pregnant or have had a previous back surgery. Patients with underlying systemic or visceral disease and specific condition such as dementia, cognitive dysfunction, visual impairment and previous history of epilepsy. Adult: 18 Year(s)-44 Year(s),Middle Aged: 45 Year(s)-64 Year(s) 19 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 11/09/2017 Health Research Ethics Committee of the Institute of Public Health Obafemi Awolowo University Ile Ife Nigeria
Ethics Committee Address
Street address City Postal code Country
Ile Ife Ile Ife 0013 Nigeria
OUTCOMES
Type of outcome Outcome Timepoint(s) at which outcome measured
Primary Outcome Pain, Disability, Fear Avoidance Belief, Kinesiophobia Baseline. 4th week and 8th week of study
Secondary Outcome Pain, Diability, Fear Avoidance Belief, Kinesiophobia Baseline. 4th week and 8th week of study
RECRUITMENT CENTRES
Name of recruitment centre Street address City Postal code Country
Obafemi Awolowo University Teaching Hospital Ile Ife Ile Ife Nigeria
Ladoke Akintola University of Technology Teaching Hospital Osogbo Osogbo Nigeria
Department of Medical Rehabilitation Obafemi Awolowo University Ile Ife Ile Ife Nigeria
FUNDING SOURCES
Name of source Street address City Postal code Country
Dr. Chidozie Mbada Obafemi Awolowo University Ile Ife Nigeria
SPONSORS
Sponsor level Name Street address City Postal code Country Nature of sponsor
Primary Sponsor Obafemi Awolowo University Ile Ife Ile Ife 0013 Nigeria University
COLLABORATORS
Name Street address City Postal code Country
CONTACT PEOPLE
Role Name Email Phone Street address
Principal Investigator Chidozie Mbada doziembada@yahoo.com +2348028252543 Ile Ife
City Postal code Country Position/Affiliation
Ile Ife Nigeria Senior Lecturer Obafemi Awolowo University
Role Name Email Phone Street address
Public Enquiries Moses Makinde momak4success@gmail.com +2348165312969 Ilesa
City Postal code Country Position/Affiliation
Ilesa Nigeria Student Obafemi Awolowo University
Role Name Email Phone Street address
Scientific Enquiries Chidozie Mbada doziembada@yahoo.com +2348028252543 Ile Ife
City Postal code Country Position/Affiliation
Ile Ife Nigeria Senior Lecturer Obafemi Awolowo University
REPORTING
Share IPD Description Additional Document Types Sharing Time Frame Key Access Criteria
Yes Federal Ministry of Health, through Institute of Pblic Health, Obafemi Awolowo University has gave us a Certificate of Confidentiality for this study. This Certificate adds special protection for research information. Informed Consent Form 2 years The information obtained during the study was used for scientific purpose with the aim of planning better treatment for patients with low back pain.
URL Results Available Results Summary Result Posting Date First Journal Publication Date
Yes Back extension-glide virtual reality game is comparable with the McKenzie extension therapy in its effect on pain and pain-related characteristics, disability, movement impairments, and quality of life. While the back extension-glide virtual reality game has superior effect in reducing Kp, it takes a higher toll on self-reported vitality/energy 12/06/2018 25/01/2019
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Result URL Hyperlinks Link To Protocol
Result URL Hyperlinks https://doi.org/10.5114/hm.2019.83998
Changes to trial information