Managing Chronic Low Back Pain Made Easier with a Mobile Health App

Phase 3

Not yet recruiting

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.

Recruitment & Eligibility

Inclusion Criteria

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.

Exclusion Criteria

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.

Primary Outcome Measures

Name	Time	Method
1. RMDQ for pain-related disability (0-24)	0, 6, 12 and 24 weeks.
2. NRS for pain intensity (0-10)	0, 6, 12 and 24 weeks.

Secondary Outcome Measures

Name	Time	Method
a) Brief Pain Inventory short form (BPI-SF).	b) Euro-QOL-5D
•Direct cost- Medical	oInsured medical costs

Locations (1): Post Graduate Institute of Medical Education and Research
🇮🇳
Chandigarh, CHANDIGARH, India
Post Graduate Institute of Medical Education and Research
🇮🇳Chandigarh, CHANDIGARH, India
Dr Babita Ghai
Principal investigator
7087009533
ghaibabita1@gmail.com