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.: PACTR202001829834757 Date of Approval: 27/01/2020
Trial Status: Registered in accordance with WHO and ICMJE standards
TRIAL DESCRIPTION
Public title Physical activity effectiveness for chronic non-specific low back pain treatment in Burundi
Official scientific title Physical activity in chronic low back pain: A randomized controlled clinical trial comparing group-based walking plus yoga versus individual physical therapy
Brief summary describing the background and objectives of the trial Low back pain (LBP) occurs in all countries and in all age groups. Working population is more disabled, especially in low-income and middle-income countries and at chronic stage. Chronicity in LBP is more closely related to biopsychosocial factors; and the best management should integrates these factors. Current guidelines recommend graded exercise or physical activity and biopsychosocial framework. Yoga is a physical activity that offers a combination of physical, psychological and spiritual well-being. Walking is low cost and easily performed physical activity that can be performed during daily activities, and requires no special training or supervision. Performed in group, yoga and walking are getting closer to the biopsychosocial framework and require minimal accessories and are therefore, more economically convenient. that is why we thought this therapy could meet the needs of chronic low back pain population in low-income countries. This study aims to highlight the effectiveness of collective and combined physical activities (yoga plus graded walking) in chronic low back patients on impairments, activity limitations and participation restriction.
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 03/02/2020
Actual trial start date 17/02/2020
Anticipated date of last follow up 02/08/2020
Actual Last follow-up date
Anticipated target sample size (number of participants) 56
Actual target sample size (number of participants)
Recruitment status Recruiting
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
Parallel: different groups receive different interventions at same time during study Randomised Stratified allocation where factors such as age, gender, center, or previous treatment are used in the stratification Sealed opaque envelopes Masking/blinding used Outcome Assessors,Participants
INTERVENTIONS
Intervention type Intervention name Dose Duration Intervention description Group size Nature of control
Experimental Group group based of yoga plus graded walking - Thirty minutes, three time a week for graded walking - Sixty minutes, three time a week for yoga Six months Experimental intervention will be implemented as group-based yoga sessions of 60 min and group-based graded walking sessions of 30 min. Graded walking will be performed by using pedometer. 28
Control Group individual physical therapy 75 min, three time a week Six months Passive mobilizations and stretch, massage, electrotherapy, thermotherapy 28 Active-Treatment of Control Group
ELIGIBILITY CRITERIA
List inclusion criteria List exclusion criteria Age Category Minimum age Maximum age Gender
- 18-65 years old - Patients willing to attend a 12-wk treatment programme - Patients with chronic (≥3 mo) or recurrent (≥3 episodes in previous 12 mo) LBP of mechanical origin - Sufficiently mobile: eg, can get up off floor unaided - Cognitive deficit - Pregnant women - Red flags indicating serious spinal pathology (eg, cancer, cauda equina lesion) - Radicular pain indicative of nerve root compression - Patients diagnosed with severe spinal stenosis, spondylolisthesis, and fibromyalgia - Comorbidities that prevent the patient from participating in group-based physical activity - Contraindication to physical activity Adolescent: 13 Year-18 Year,Adult: 19 Year-44 Year,Aged: 65+ Year(s),Middle Aged: 45 Year(s)-64 Year(s) 18 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 12/12/2019 National ethics committee
Ethics Committee Address
Street address City Postal code Country
3 Hospital Avenue Bujumbura 6807 Burundi
OUTCOMES
Type of outcome Outcome Timepoint(s) at which outcome measured
Primary Outcome Activity limitations (Roland-Morris Disability questionnaire) baseline, after three months, after six months
Secondary Outcome Pain intensity (Numerical rating scale) Baseline, at three months, at six months
Secondary Outcome Muscular endurance (Shirado test, Sorensen test) Baseline, at three months, at six months
Secondary Outcome Depression (Beck Depression Inventory) Baseline, at three months, at six months
Secondary Outcome Patient beliefs (Fear-Avoidance Beliefs Questionnaire) Baseline, at three months, at six months
Secondary Outcome Physical Fitness (Borg Rating of Perceived Exertion scale, resting heart rate) baseline, at three months, at six months
Secondary Outcome Self-perception of performance (Canadian occupational performance measure) Baseline, at three months, at six months
Secondary Outcome Participation (5-Item Pain Disability Index) Baseline, at three months, at six months
RECRUITMENT CENTRES
Name of recruitment centre Street address City Postal code Country
Physical Therapy and Rehabilitation Department of University Hospital Center of Kamenge Boulevard du 28 Novembre Bujumbura 2210 Burundi
FUNDING SOURCES
Name of source Street address City Postal code Country
Wallonie Bruxelles International and Catholic University of Louvain Place Sainctelette 2 Brussels 1080 Belgium
SPONSORS
Sponsor level Name Street address City Postal code Country Nature of sponsor
Secondary Sponsor APEFE 2 Place Sainctelette Brussels 1080 Belgium Equipment for the Study
COLLABORATORS
Name Street address City Postal code Country
Felix Kinanira 2 Bujumbura Burundi
Bleyenheuft Yannick 53 Avenue Mounier Brussels 1200 Belgium
Jean Louis Thonnard 53 Avenue Mounier Brussels 1200 Belgium
Alexis Sinzakaraye Boulevard du 28 Novembre Bujumbura Burundi
Oyene Kossi Wansirou Parakou Benin
CONTACT PEOPLE
Role Name Email Phone Street address
Principal Investigator Ildephonse Nduwimana ilwimana@gmail.com 25779376031 115 Avenue Mpungwe
City Postal code Country Position/Affiliation
Bujumbura Burundi PhD student at Catholic University of Louvain
Role Name Email Phone Street address
Scientific Enquiries Jean Louis Thonnard jean-Louis.Thonnard@uclouvain.be +32478278233 53 Avenue Mounier
City Postal code Country Position/Affiliation
Brussels 1200 Belgium Profesor emeritus at Catholic University of Louvain
Role Name Email Phone Street address
Public Enquiries Oyene Kossi oyene.kossi@gmail.com +22995016605 Parcelle I, lot W64
City Postal code Country Position/Affiliation
Parakou Benin Professor and Researcher at National School of Public Health and Epidemiology of Parakou University in Benin
REPORTING
Share IPD Description Additional Document Types Sharing Time Frame Key Access Criteria
Yes Data for each participant Informed Consent Form,Statistical Analysis Plan,Study Protocol 1 year Controlled access
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