Health Condition 1: M545- Low back pain
Conditions
Interventions
Sponsors
Eligibility
Inclusion criteria
Inclusion criteria: 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.
Exclusion criteria
Exclusion criteria: 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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 1. RMDQ for pain-related disability (0-24) 2. NRS for pain intensity (0-10)Timepoint: 0, 6, 12 and 24 weeks. | — |
Secondary
| Measure | Time frame |
|---|---|
| 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)Timepoint: 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 ScaleTimepoint: 0, 6, 12 and 24 weeks. | — |
Countries
India
Contacts
Post Graduate Institute of Medical Education and Research