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 0835 or +27 21 938 0967
Email: pactradmin@mrc.ac.za Website: pactr.samrc.ac.za
Trial no.: PACTR202607620563644 Date of Registration: 29/07/2026
Trial Status: Registered in accordance with WHO and ICMJE standards
TRIAL DESCRIPTION
Public title Pilot Feasibility of HRehab4Back: A Culturally Tailored Mobile Application for Self-Management of Chronic Low Back Pain in Katsina State, Nigeria
Official scientific title A Single-Arm Mixed-Methods Pilot Feasibility Study of HRehab4Back, a Culturally Tailored Digital Physiotherapy Intervention for Supporting Self-Management of Chronic Low Back Pain in Katsina State, Nigeria
Brief summary describing the background and objectives of the trial Chronic low back pain is the leading cause of disability worldwide and places a considerable burden on individuals, healthcare systems, and society. Access to physiotherapy services in Northwest Nigeria is limited by shortages of rehabilitation professionals, long travel distances, financial constraints, and insecurity. Digital physiotherapy interventions may improve access to evidence-based self-management support. HRehab4Back is a culturally tailored mobile application designed to provide education, exercise therapy, behavioral support, symptom monitoring, and personalized feedback for individuals with chronic low back pain. This pilot study aims to determine the feasibility, usability, acceptability, and preliminary clinical outcomes of the intervention. The primary objective is to determine the feasibility and usability of the HRehab4Back mobile application among adults with chronic low back pain. and the secondary objective is to evaluate acceptability of HRehab4Back, participant adherence, pain intensity, disability, physical activity, kinesiophobia, self-efficacy, and health-related quality of life
Type of trial Non-Randomised
Acronym (If the trial has an acronym then please provide) HRehab4Back Pilot Trial
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 07/09/2026
Actual trial start date 07/09/2026
Anticipated date of last follow up 02/11/2026
Actual Last follow-up date 02/11/2026
Anticipated target sample size (number of participants) 50
Actual target sample size (number of participants) 50
Recruitment status Not yet 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
Single Group Non-randomised Allocation Sequence/Code was not concealed Open-label(Masking Not Used)
INTERVENTIONS
Intervention type Intervention name Dose Duration Intervention description Group size Nature of control
Experimental Group HRehab4Back Participants will have HRehab4Back installed on their mobile phones and will be guided on how to use the app. Participants will be ask to use the app in addition for the stipulated period participants will use the app and follow instructions for education and daily exercises, which are personalized for the period of 8 weeks; however, participants will be back for evaluation at 4 and 8 weeks The HRehab4Back is a digital physiotherapy intervention that will be developed and tested for effectiveness on specific outcome measures, the intervention will be developed in the form of mHealth application; it will contain modules on Evidence-based patient education, Individually prescribed exercise programmes, structured exercise videos, goal setting, behavioural support, daily reminders, symptom monitoring, progress tracking and personalised feedback to enhance active participation and adherence to home programs specific to the disadvantaged population of Northwest Nigeria affected with problems of transportation and insecurity 50
ELIGIBILITY CRITERIA
List inclusion criteria List exclusion criteria Age Category Minimum age Maximum age Gender
Participants must: Be ≥18 years of age; Have chronic low back pain for >3 months; Own an Android smartphone; Understand read and write hausa language; Be willing to provide informed consent. Participants with: Spinal fracture; Spinal tumour; Inflammatory spinal disease; Previous spinal surgery; Pregnancy; Severe neurological disorders; Cognitive impairment; Contraindications to exercise Adult: 18 Year(s)-44 Year(s),Aged: 65 Year(s)-79 Year(s),Middle Aged: 45 Year(s)-64 Year(s) 18 Year(s) 80 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
No 01/06/2026 Katsina State Ministry of Health Research and Ethics Committee
Ethics Committee Address
Street address City Postal code Country
Ministry of Health Katsina State Secretariate Complex Katsina 820211 Nigeria
OUTCOMES
Type of outcome Outcome Timepoint(s) at which outcome measured
Primary Outcome Usability is to be measured using System Usability Scale (SUS) Acceptability is to be measured Technology Acceptance Model (TAM) questionnaire Feasibility Recruitment, retention, adherence, and completion rates at 4 weeks and 8 weeks post intervention
Secondary Outcome Pain intensity using Numerical Rating Scale Disability using Oswestry Disability Index Kinesiophobia using Tampa Scale of Kinesiophobia Self-efficacy using Self-Efficacy for Exercise Scale Physical activity using International Physical Activity Questionnaire Quality of life using SF-12 or SF-36 (use the one specified in your protocol) outcomes will be measured at baseline, 4 weeks post intervention and 8 weeks post intervention
RECRUITMENT CENTRES
Name of recruitment centre Street address City Postal code Country
General Amadi Rimi Specialist Hospital Katsina and Federal Teaching Hospital Katsina Dutsinma road and murtala muhammad way respectively katsina 820211 Nigeria
FUNDING SOURCES
Name of source Street address City Postal code Country
Aliyu Musa N0. 4 Kankiyan Katsina Road, Barhim Estate Katsina Katsina 820211 Nigeria
SPONSORS
Sponsor level Name Street address City Postal code Country Nature of sponsor
Primary Sponsor Umaru Musa Yaradua University Dutsinma Road Katsina Katsina 820211 Nigeria University
COLLABORATORS
Name Street address City Postal code Country
CONTACT PEOPLE
Role Name Email Phone Street address
Principal Investigator Aliyu Musa aliyu.m@umyu.edu.ng +2348063428364 No. 4 Kankiyan Katsina, Barhim Estate Katsina
City Postal code Country Position/Affiliation
Katsina 820211 Nigeria Lecturer Umaru Musa Yaradua University Katsina
Role Name Email Phone Street address
Public Enquiries Usman Abubakar Modibbo ptmodibbo@gmail.com +2348038427127 Dutsen safe low cost katsina
City Postal code Country Position/Affiliation
Kasina 820211 Nigeria Administrator
Role Name Email Phone Street address
Scientific Enquiries Mukaddas O Akindele mukaakin@gmail.com +2348035537101 BUK Staff Quaters
City Postal code Country Position/Affiliation
Kano 713281 Nigeria Professor Bayero University Kano
REPORTING
Share IPD Description Additional Document Types Sharing Time Frame Key Access Criteria
Yes De-identified individual participant data (IPD) underlying the results reported in the publication, including baseline and post-intervention outcome measures (e.g., pain intensity, functional disability, kinesiophobia, self-efficacy, physical activity, quality of life, usability, feasibility, and acceptability measures), together with the study protocol, statistical analysis plan, data dictionary, and informed consent template. Clinical Study Report,Informed Consent Form,Statistical Analysis Plan,Study Protocol Data will become available beginning 6 months after publication of the primary study results and will remain available for 5 years thereafter. Available upon reasonable request to qualified researchers with a methodologically sound proposal, subject to approval by the Principal Investigator and a signed Data Sharing Agreement.
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
Section Name Field Name Date Reason Old Value Updated Value
Ethics Ethics List 23/07/2026 Phone number and email changed to institutional from personal details FALSE, Katsina State Ministry of Health Research and Ethics Committee , Ministry of Health Katsina State Secretariate Complex, Katsina, 820211, Nigeria, 01 Jun 2026, , +2348035943290, msbichi@gmail.com, FALSE, Katsina State Ministry of Health Research and Ethics Committee , Ministry of Health Katsina State Secretariate Complex, Katsina, 820211, Nigeria, 01 Jun 2026, , +2348061194975, smoh.katsinastate@yahoo.com,
Section Name Field Name Date Reason Old Value Updated Value
Funding Source FundingSources List 23/07/2026 Name changed to that of principal investigator self funded, N0. 4 Kankiyan Katsina Road, Barhim Estate Katsina, Katsina, 820211, Nigeria, Self Funded, Aliyu Musa, N0. 4 Kankiyan Katsina Road, Barhim Estate Katsina, Katsina, 820211, Nigeria, Self Funded,