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.: PACTR202105740118709 Date of Approval: 06/05/2021
Trial Status: Registered in accordance with WHO and ICMJE standards
TRIAL DESCRIPTION
Public title A Crossover Design for Comparative Effectiveness: A Randomised Controlled Trial of Backward Walking for Chronic Low Back Pain Patients in Solwezi District, Zambia
Official scientific title A Crossover Design for Comparative Effectiveness: A Randomised Controlled Trial of Backward Walking for Chronic Low Back Pain Patients in Solwezi District, Zambia
Brief summary describing the background and objectives of the trial Chronic low back pain (LBP) is a growing health challenge globally. Though exercise is recommended in all clinical guidelines, little is know on the effects of backward walking. Experimental and observational studies have reported potential and with the growing endorsement and popularity of BW in rehabilitation and fitness, it is worthwhile testing the intervention in a controlled environment like a RCT. The objectives of the present study are: 1. To establish baseline clinical profile of LBP patients in Solwezi 2. To determine the effects with usual care physiotherapy (UCPT) on pain intensity when compared to UCPT alone. 3. To analyze the effects of BW with UCPT on physical function performance in comparison to UCPT 4. To investigate the comparative impact of BW with UCPT on levels of disability when compared to UCPT alone.
Type of trial RCT
Acronym (If the trial has an acronym then please provide)
Disease(s) or condition(s) being studied Orthopaedics
Sub-Disease(s) or condition(s) being studied
Purpose of the trial Rehabilitation
Anticipated trial start date 01/06/2021
Actual trial start date 01/06/2021
Anticipated date of last follow up 19/07/2021
Actual Last follow-up date 12/07/2021
Anticipated target sample size (number of participants) 26
Actual target sample size (number of participants) 25
Recruitment status Completed
Publication URL https://sciencepg.com/journal/paperinfo?journalid=251&doi=10.11648/j.sjph.20221005.15
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 Permuted block randomization Sealed opaque envelopes Masking/blinding used Outcome Assessors
INTERVENTIONS
Intervention type Intervention name Dose Duration Intervention description Group size Nature of control
Experimental Group Backward walking on treadmill as adjunct to heat therapy massage and home exercise program Three sessions of 45 minutes three time a week for two weeks before crossing over to opposite arm (usual care physiotherapy alone) 2 weeks on each arm with 1 week wash out period (total 4 weeks) 5 minutes forward walking on treadmill as warm up. Upright backward walking on treadmill self paced but encouraged to walk as fast as one can for 10 minutes 13
Control Group Usual care physiotherapy alone three sessions per week for 2 weeks 2 weeks 1. heat therapy: Infrared radiation or hot pack on the back for 10 minutes 2. Back massage 3. Advice to exercise at home 13 Active-Treatment of Control Group
ELIGIBILITY CRITERIA
List inclusion criteria List exclusion criteria Age Category Minimum age Maximum age Gender
1. Pain, stiffness in lower back below costal margin and above iliac crest with or without leg pain of unknown cause of three months or more duration. 2. Above the age of 18 years 3. Able to stand and walk backwards independently 4. Able to comply with study requirements including able to read and understand the questionnaire 1. History or presence of any red flag of LBP including cancer, night sweats and fever 2. Severe back pain of intensity above 8 on visual analogue scale 3. Lower limb injury or surgery interfering with walking 4. Pregnant women Adult: 19 Year-44 Year,Aged: 65+ Year(s),Middle Aged: 45 Year(s)-64 Year(s) 18 Year(s) 70 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 21/07/2021 ERES Converge Limited
Ethics Committee Address
Street address City Postal code Country
Cnr Joseph Mwilwa and Great East road, Rhodes Park Lusaka 10101 Zambia
OUTCOMES
Type of outcome Outcome Timepoint(s) at which outcome measured
Primary Outcome Pain intensity session one and six of each of the two treatment periods
Secondary Outcome Physical performance level session one and six on each of the two treatment periods
Secondary Outcome Self rated disability session one and six on each of the two treatment periods
RECRUITMENT CENTRES
Name of recruitment centre Street address City Postal code Country
Solwezi General Hospital Along Kansanshi road Solwezi 110009 Zambia
Kansanshi Mine Hospital Mushitala off old Congo road Solwezi 110536 Zambia
FUNDING SOURCES
Name of source Street address City Postal code Country
Justin Bwalya Mushitala along old Congo road Solwezi 110536 Zambia
SPONSORS
Sponsor level Name Street address City Postal code Country Nature of sponsor
Primary Sponsor Justin Bwalya Mushitala off old Congo road Solwezi 110536 Zambia Individual
COLLABORATORS
Name Street address City Postal code Country
Brian Chanda Chiluba Ridgeway campus Lusaka 50110 Zambia
Dr. Martha Banda Chalwe Ridgeway campus Lusaka 110536 Zambia
Professor Kristen Mussellman 27 kings collage circle Ontario M5S United States Minor Outlying Islands
CONTACT PEOPLE
Role Name Email Phone Street address
Principal Investigator Justin Bwalya justinbwalya@yahoo.co.uk +260961486078 Mushitala off old Congo road
City Postal code Country Position/Affiliation
Solwezi 110536 Zambia Post graduate MSc Student University of Zambia
Role Name Email Phone Street address
Scientific Enquiries Brian Chiluba brian.chiluba@unza.zm +260977896377 Ridgeway campus
City Postal code Country Position/Affiliation
Lusaka 50110 Zambia Lecturer and researcher University of Zambia School of health sciences
Role Name Email Phone Street address
Public Enquiries Martha Banda martha.chalwe@unza.zm +260966754576 Ridgeway campus
City Postal code Country Position/Affiliation
Lusaka 50110 Zambia Lecturer researcher and post graduate coordinator University of Zambia School of Health Sciences.
REPORTING
Share IPD Description Additional Document Types Sharing Time Frame Key Access Criteria
Yes IPD will be shared with other researchers Clinical Study Report,Informed Consent Form,Statistical Analysis Plan,Study Protocol Will be available in December 2021 for period unlimited Open 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