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.: PACTR202208607830603 Date of Approval: 16/08/2022
Trial Status: Retrospective registration - This trial was registered after enrolment of the first participant
TRIAL DESCRIPTION
Public title EFFECT OF TELEREHABILITATION-BASED CORE-STABILITY EXERCISE ON PAIN-RELATED DISABILITY, PAIN SELF-EFFICACY AND PSYCHOLOGICAL FACTORS IN PATIENTS WITH NON-SPECIFIC CHRONIC LOW BACK PAIN.
Official scientific title EFFECT OF TELEREHABILITATION-BASED CORE-STABILITY EXERCISE ON PAIN-RELATED DISABILITY, PAIN SELF-EFFICACY AND PSYCHOLOGICAL FACTORS IN PATIENTS WITH NON-SPECIFIC CHRONIC LOW BACK PAIN.
Brief summary describing the background and objectives of the trial Telerehabilitation has been used to improve on health care in recent times. However, not so much is known on the effects of telerehabilitation incorporating core-stability exercise in the management of pain-related disability, pain-self efficacy and psychological factors of patients with non-specific chronic low back pain. This study is aimed to determine and compare the efficacy of telerehabilitation-based core-stability exercise (TCSE) and clinical-based core stability exercise (CCSE) in the management of pain-related disability, pain-self efficacy and psychological factors (depression, anxiety and stress) in patients with non-specific chronic 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 Rehabilitation
Anticipated trial start date 04/01/2022
Actual trial start date 07/01/2022
Anticipated date of last follow up 03/06/2022
Actual Last follow-up date 10/06/2022
Anticipated target sample size (number of participants) 50
Actual target sample size (number of participants) 50
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
Crossover: all participants receive all interventions in different sequence during study Randomised Simple randomization using a randomization table created by a computer software program Numbered containers Masking/blinding used Participants
INTERVENTIONS
Intervention type Intervention name Dose Duration Intervention description Group size Nature of control
Experimental Group TELEREHABILITATION 8 WEEKS Assessment of Demographics and outcome measures using google forms. Participants were treated virtually over interactive devices, and a WhatsApp group created to treat core-stability exercises for 30 minutes duration with a frequency of two treatment sessions per week with a day interval for 8 consecutive weeks. 25
Control Group Group A 8 WEEKS Assessment of Demographics and outcome measures physically. Participants were treated physically with core-stability exercises for 30 minutes duration with a frequency of two treatment sessions per week with a day interval for 8 consecutive weeks. 25 Active-Treatment of Control Group
ELIGIBILITY CRITERIA
List inclusion criteria List exclusion criteria Age Category Minimum age Maximum age Gender
1. Patients referred to physiotherapy outpatient`s clinic with diagnosis of non-specific chronic low back pain with and without pain radiating to one or both lower limbs. 2. Patients with greater than 5 on the Visual Analogue Scale (VAS). 1. Participants with cognitive limitation. 2. Participants with medical or surgical conditions which may hinder exercise performance e.g Systemic lupus erythematosus, Lymphedema. 3. Participants who have a history of orthopaedics problem including conditions of the back that would affect their abilities to sustain core stability exercise. 4. Patients who are not knowledgeable in the use of Information and Communication Technology (ICT). Adult: 19 Year-44 Year,Aged: 65+ Year(s),Middle Aged: 45 Year(s)-64 Year(s) 18 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 07/07/2022 College of Medicine University of Lagos Health Research Ethics Committee
Ethics Committee Address
Street address City Postal code Country
2nd Floor Biomedical Engineering Block College of Medicine University of Lagos, Idi-Araba, Lagos Lagos 100254 Nigeria
OUTCOMES
Type of outcome Outcome Timepoint(s) at which outcome measured
Primary Outcome Pain Disability At Baseline- 0 week, Midline - 4 weeks and End line - 8 weeks
Primary Outcome Pain Self- Efficacy At Baseline - 0 week, Midline - 4 weeks and End line - 8 weeks
Secondary Outcome Depression, Anxiety and Stress DASS Factor At Baseline - 0 week, Midline - 4 weeks and End line - 8 weeks
RECRUITMENT CENTRES
Name of recruitment centre Street address City Postal code Country
National Orthopedic hospital Lagos. 120/124 Ikorodu- Ososun Rd, Igbobi 102216, Lagos Lagos 102216 Nigeria
FUNDING SOURCES
Name of source Street address City Postal code Country
Adedeji Adebola Department of Physiotherapy, College of Medicine, University of Lagos Lagos 101014 Nigeria
SPONSORS
Sponsor level Name Street address City Postal code Country Nature of sponsor
Primary Sponsor Mr Adedeji Adeyinka No 4, Agbowa Ibeshe, Off Owode Ibeshe, Ikorodu Lagos 104214 Nigeria Individual
COLLABORATORS
Name Street address City Postal code Country
CONTACT PEOPLE
Role Name Email Phone Street address
Principal Investigator Ashiyat Akodu akoduashiyat@gmail.com +2348034269053 Department of Physiotherapy, College of Medicine, University of Lagos
City Postal code Country Position/Affiliation
Lagos 101014 Nigeria Senior Lecturer
Role Name Email Phone Street address
Public Enquiries Adebola Adedeji adeboladedeji@gmail.com +2349054550820 Department of Physiotherapy, College of Medicine, University of Lagos
City Postal code Country Position/Affiliation
Lagos 101014 Nigeria Student Researcher
Role Name Email Phone Street address
Scientific Enquiries Adebola Adedeji adeboladedeji@gmail.com +2349054550820 Department of Physiotherapy, College of Medicine, University of Lagos
City Postal code Country Position/Affiliation
Lagos 101014 Nigeria Student Researcher
REPORTING
Share IPD Description Additional Document Types Sharing Time Frame Key Access Criteria
Yes The Individual Participant Data would include socio-demographic data and outcome measures which would be obtained from the participants before the trial (baseline), during the trial and after trial. An informed consent would be obtained from each of the participants and they will be assured of confidentiality of all data given. After completion of the trial and following publication, participants data obtained for the purpose of the research would be made available to anyone who wishes to access the study, with the identity of the participants held confidential. Informed Consent Form,Statistical Analysis Plan,Study Protocol Following publication, No end date Anyone who wishes to access the data
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