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.: PACTR202208757153267 Date of Approval: 25/08/2022
Trial Status: Retrospective registration - This trial was registered after enrolment of the first participant
TRIAL DESCRIPTION
Public title EFFECTS OF BACK EXTENSION MUSCLE ENDURANCE EXERCISE AND McKENZIE THERAPY ON SELECTED BIOMARKERS AND CLINIC OUTCOMES IN LONG-TERM LOW-BACK PAIN
Official scientific title EFFECTS OF BACK EXTENSION MUSCLE ENDURANCE EXERCISE AND McKENZIE THERAPY ON SELECTED BIOMARKERS AND CLINIC OUTCOMES IN LONG-TERM LOW-BACK PAIN
Brief summary describing the background and objectives of the trial This study determined the effect of McKenzie Extension Protocol and muscle endurance exercises on selected clinical characteristics (pain, functional disability and general health status); and biomarker of muscle status (creatinine kinase) and inflammation (anti-inflammatory cytokines i.e. IL-4 and IL-10); in patients with Long-term Low-back Pain; investigate the effects of static back extension endurance on selected clinical characteristics and biomarkers of muscle status and inflammation among patients with low back pain. It also evaluated the effects of dynamic back extension endurance on selected clinical characteristics and biomarkers of muscle status and inflammation.
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 10/12/2020
Actual trial start date 10/12/2020
Anticipated date of last follow up 22/03/2021
Actual Last follow-up date 22/03/2021
Anticipated target sample size (number of participants) 76
Actual target sample size (number of participants) 76
Recruitment status Completed
Publication URL
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 McKenzie Extension Protocol Three times a week Six weeks The McKenzie Extension Protocol group received McKenzie protocols involving a specific sequence of lumbosacral repeated movements in extension 25 Active-Treatment of Control Group
Experimental Group Static back extensors endurance Thrice weekly Six weeks The static back extensors endurance group were treated with five different low-back extensor muscles endurance protocols of increasing level of difficulty 22
Experimental Group Dynamic back extensors endurance Thrice weekly Six weeks The Dynamic back extensors endurance received a dynamic replica of the static back extensors endurance, instead of static posturing of the trunk in static back extensors endurance, the participants were asked to move the trunk and the suspended limbs. 29
ELIGIBILITY CRITERIA
List inclusion criteria List exclusion criteria Age Category Minimum age Maximum age Gender
Patients with clinical diagnosis of chronic non-specific 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 having a known co-morbidity or reported history of cardiovascular disease contraindicating exercise Patients being pregnant, previous back surgery, 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 10/12/2020 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, 3rd and 6th week
Secondary Outcome Level of serum creatinine kinase, IL4, and IL10, Back Extension Muscles’ Endurance, Activity Limitation, Participation Restriction, and General Health Status. Baseline, 3rd and 6th week
RECRUITMENT CENTRES
Name of recruitment centre Street address City Postal code Country
Physiotherapy Clinic Ladoke Akintola University Teaching Hospital Physiotherapy Clinic, Ladoke Akintola University Teaching Hospital 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 Mistura Olaoye olaoyemst@yahoo.com 08130708507 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 Mistura Olaoye olaoyemst@yahoo.com 08130708507 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
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