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.: PACTR202101786660911 Date of Approval: 11/01/2021
Trial Status: Retrospective registration - This trial was registered after enrolment of the first participant
TRIAL DESCRIPTION
Public title EFFECTS OF VERTICAL OSCILLATORY PRESSURE AND SELF-TREATMENT MOBILE-APPLICATION ON CLINICAL AND PSYCHOSOCIAL OUTCOMES OF PATIENTS WITH LONG-TERM LOW-BACK PAIN
Official scientific title EFFECTS OF VERTICAL OSCILLATORY PRESSURE AND SELF TREATMENT MOBILE APPLICATION ON CLINICAL AND PSYCHOSOCIAL OUTCOMES OF PATIENTS WITH LONG-TERM LOW-BACK PAIN
Brief summary describing the background and objectives of the trial This study compared the efficacy of vertical oscillatory pressure and mobile-phone application of McKenzie back extension technique in the management of long-term non-specific 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 04/03/2019
Actual trial start date 04/03/2019
Anticipated date of last follow up 15/07/2019
Actual Last follow-up date 15/07/2019
Anticipated target sample size (number of participants) 49
Actual target sample size (number of participants) 49
Recruitment status Completed
Publication URL None
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 Vertical oscillatory pressure 10 oscillations of a grade II digital pressure mobilization force on the offending spinous process Thrice weekly for eight weeks Nwugarian vertical oscillatory pressure 21 Active-Treatment of Control Group
Experimental Group Telerehabilitation based McKenzie therapy Three times Eight weeks The patients received a mobile phone-based application of ‘McKenzie Extension Protocol involving a specific sequence of lumbosacral repeated movements in extension aimed to centralize, decrease or abolish symptoms. 28
ELIGIBILITY CRITERIA
List inclusion criteria List exclusion criteria Age Category Minimum age Maximum age Gender
Patients diagnosed of non-specific LBP of not less than three months duration Patients without any obvious deformities affecting the trunk or upper and lower extremities. Patients having directional preference for extension on McKenzie Institute’s Lumbar Spine Assessment Algorithm. Patients with previous history of spinal surgery within the last 12 months. Patients with red flags (such as tumor, spinal infection, spinal fracture, cauda equine syndrome), yellow flags (such as depression, neurologic problems, etc). Patients that were pregnant. Adult: 19 Year-44 Year,Aged: 65+ Year(s),Middle Aged: 45 Year(s)-64 Year(s) 44 Year(s) 75 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 25/02/2019 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 Baseline, fourth week and eight week
Secondary Outcome Activity Limitation, Participation Restriction and Health-related Quality of Life. Baseline, fourth week and eight 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
Olanipekun Oladele 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 Olanipekun Oladele 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 Oladele Olanipekun oluwasegundele2@yahoo.com +2347038640133 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 Oladele Olanipekun oluwasegundele2@yahoo.com +2347038640133 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 Oladele Olanipekun Oluwasegundele2@yahoo.com +2347038640133 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 (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
None Yes 23/12/2020 18/11/2020
Result Upload 1: Result Upload 2: Result Upload 3: Result Upload 4: Result Upload 5:
Result - 23/12/2020
Result URL Hyperlinks Link To Protocol
Result URL Hyperlinks None
Changes to trial information