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CTRI Number  CTRI/2025/06/088412 [Registered on: 06/06/2025] Trial Registered Prospectively
Last Modified On: 04/06/2025
Post Graduate Thesis  No 
Type of Trial  Interventional 
Type of Study   Physiotherapy (Not Including YOGA)
Behavioral 
Study Design  Randomized, Parallel Group, Active Controlled Trial 
Public Title of Study   Managing Chronic Low Back Pain Made Easier with a Mobile Health App 
Scientific Title of Study   Development, testing, and evaluating the effectiveness of mobile health-based multi-disciplinary management of chronic low back pain 
Trial Acronym  NIL 
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Babina Rani 
Designation  Physiotherapist 
Affiliation  Post Graduate Institute of Medical Education and Research 
Address  Room No.5023, Pain Clinic, New OPD, Post Graduate Institute of Medical Education and Research, Sector 12, Chandigarh

Chandigarh
CHANDIGARH
160012
India 
Phone  9996499061  
Fax    
Email  says2babina@gmail.com  
 
Details of Contact Person
Scientific Query  
Name  Babina Rani 
Designation  Physiotherapist 
Affiliation  Post Graduate Institute of Medical Education and Research 
Address  Room No.5023, Pain Clinic, New OPD, Post Graduate Institute of Medical Education and Research, Sector 12, Chandigarh

Chandigarh
CHANDIGARH
160012
India 
Phone  9996499061  
Fax    
Email  says2babina@gmail.com  
 
Details of Contact Person
Public Query  
Name  Babina Rani 
Designation  Physiotherapist 
Affiliation  Post Graduate Institute of Medical Education and Research 
Address  Room No.5023, Pain Clinic, New OPD, Post Graduate Institute of Medical Education and Research, Sector 12, Chandigarh

Chandigarh
CHANDIGARH
160012
India 
Phone  9996499061  
Fax    
Email  says2babina@gmail.com  
 
Source of Monetary or Material Support  
Post Graduate Institute of Medical Education and Research, Sector 12, Chandigarh 
 
Primary Sponsor  
Name  Post Graduate Institute of Medical Education and Research 
Address  Sector 12, Chandigarh-160012, India 
Type of Sponsor  Research institution and hospital 
 
Details of Secondary Sponsor  
Name  Address 
NIL  NIL 
 
Countries of Recruitment     India  
Sites of Study  
No of Sites = 1  
Name of Principal Investigator  Name of Site  Site Address  Phone/Fax/Email 
Dr Babita Ghai  Post Graduate Institute of Medical Education and Research  Room No. 5023, Pain Clinic, New OPD, Post Graduate Institute of Medical Education and Research, Sector 12, Chandigarh
Chandigarh
CHANDIGARH 		 7087009533

ghaibabita1@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
PGIMER IEC  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: M545||Low back pain,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Intervention  App Intervention  In addition to usual care, the mobile application will be installed in the patient’s smartphones, and the application will guide the subjects through textual facts or pre-recorded patient education and management strategies content, including various forms of symptom- and goal- specific exercises. The videos will teach a graded way of progressing through the exercises, as per the progress in patient’s condition recorded week wise. The subjects will be instructed to perform exercises 2 times daily, 5 days a week, and to follow the management plan for a duration of minimum 12 weeks. 
Comparator Agent  Usual Care  Routine care includes a back care booklet/information pamphlet, patient education, motivational interviewing, and prescribing and demonstrating the specific exercises and medicines. The subjects will be instructed to perform exercises 2 times daily, 5 days a week, and to follow the management plan for a duration of minimum 12 weeks. 
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  65.00 Year(s)
Gender  Both 
Details  1) non-specific CLBP (of more than3months duration and severity of 4-8 on NPRS)
2) Both group subjects or their caregivers should have a smartphone operated on Android system, and a basic operational knowledge of the same. 
 
ExclusionCriteria 
Details  1) uncontrolled DM/HTN/CAD, 2) cognitive deficit, 3) systemic/organic/traumatic/surgical cause of LBP, 4) serious depression or any other mental disorder, 5) pregnant/lactating mothers, 6) any relative/absolute contraindication for exercise, and 7) h/o minimally invasive injection intervention pain management in 3 months prior to enrolment.  
 
Method of Generating Random Sequence   Computer generated randomization 
Method of Concealment   Sequentially numbered, sealed, opaque envelopes 
Blinding/Masking   Outcome Assessor Blinded 
Primary Outcome  
Outcome  TimePoints 
1. RMDQ for pain-related disability (0-24)
2. NRS for pain intensity (0-10) 		 0, 6, 12 and 24 weeks. 
 
Secondary Outcome  
Outcome  TimePoints 
a) Brief Pain Inventory short form (BPI-SF).
b) Euro-QOL-5D
c) Hospital Anxiety and Depression Scale (HADS)
d) Patients’ Global Impression of Change (PGIC)
e) Clinical adherence scale (CAS)
f) Exercise Adherence Scale (EARS) 		 BPI-SF, Euro-QoL, HADS: 0, 6, 12 and 24 weeks.
PGIC, CAS, EARS: 6, 12 and 24 weeks 
• Direct cost- Medical
o Insured medical costs
o Uninsured/Out-of-pocket expenses (OOPE)
• Direct cost- Non-Medical
o Boarding, lodging, and transportation
o Caregiver costs
• Indirect cost
o Productivity loss
• Financial Sources
• Health Insurance
• Catastrophic health spending
• Socioeconomic status: using modified Kuppuswamy Scale  		 0, 6, 12 and 24 weeks. 
 
Target Sample Size   Total Sample Size="50"
Sample Size from India="50" 
Final Enrollment numbers achieved (Total)= "Applicable only for Completed/Terminated trials"
Final Enrollment numbers achieved (India)="Applicable only for Completed/Terminated trials" 
Phase of Trial   Phase 3 
Date of First Enrollment (India)   01/12/2025 
Date of Study Completion (India) Applicable only for Completed/Terminated trials 
Date of First Enrollment (Global)  Date Missing 
Date of Study Completion (Global) Applicable only for Completed/Terminated trials 
Estimated Duration of Trial   Years="2"
Months="0"
Days="0" 
Recruitment Status of Trial (Global)   Not Yet Recruiting 
Recruitment Status of Trial (India)  Not Yet Recruiting 
Publication Details   N/A 
Individual Participant Data (IPD) Sharing Statement

Will individual participant data (IPD) be shared publicly (including data dictionaries)?  

Response - NO
Brief Summary  

Primary Purpose:
To develop, test, and evaluate the effectiveness of a mobile health-based multidisciplinary management application for patients with non-specific chronic low back pain. The goal is to complement usual clinical care by improving adherence, promoting self-management, and reducing pain-related disability and economic burden.

Hypothesis:
The smartphone application-based multidisciplinary management will be more clinically effective and significantly reduce the economic burden for patients with non-specific chronic low back pain compared to routine care alone.

Methodology:
The study will be conducted in three phases. Phase one involves development and validation of the application content with expert input. Phase two will assess feasibility and acceptability of the app prototype in a prospective, uncontrolled trial involving 15 patients. Phase three will consist of a two-arm pilot randomized controlled trial enrolling 50 patients, randomized to either routine care alone or routine care plus app-guided management. Primary outcomes will include changes in pain intensity and disability scores. Secondary outcomes will include quality of life, mental health, global impression of change, adherence, and economic burden measures. Follow-up assessments will be conducted at baseline, 6 weeks, 12 weeks, and 24 weeks.

 
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