Biopsychosocial care compared with routine physical therapy for chronic low back pain
Biopsychosocial Model-based Care Versus Routine Physical Therapy in Chronic Back Pain
This trial will test whether adding a biopsychosocial approach to routine exercises helps adults with chronic low back pain more than routine physical therapy alone.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 80 (estimated) |
| Ages | 25 Years to 60 Years |
| Sex | All |
| Sponsor | Lahore University of Biological and Applied Sciences Academic / other |
| Locations | 1 site (Lahore, Punjab Province) |
| Trial ID | NCT07280806 on ClinicalTrials.gov |
What this trial studies
This randomized comparative trial will assign adults with non-specific chronic low back pain to either routine physical therapy (moist hot pack, TENS, stretching, and strengthening/stabilization exercises) or a biopsychosocial (BPS) model-based care package that adds Maitland mobilization (Grade I–II central PA) and targeted psychosocial strategies and education. Primary outcomes include pain self-efficacy and disability, with secondary outcomes of inflammatory markers and perceived social support measured at baseline and after the intervention period. Eligible participants are aged 25–60 with pain for at least 12 weeks and a VAS ≥3, and exclusions include specific spinal pathology, neurological deficits, prior lumbar surgery, major psychiatric illness, pregnancy, or current structured physiotherapy/psychological treatment. The study is conducted at the University of Lahore with random allocation to two equal groups receiving the described interventions.
Who should consider this trial
Good fit: Adults aged 25–60 with non-specific chronic low back pain lasting at least 12 weeks and a pain score of 3 or higher on the VAS who are not currently in structured physiotherapy or psychological treatment are ideal candidates.
Not a fit: Patients with specific spinal pathology, neurological deficits or radiculopathy, prior lumbar surgery, major psychiatric illness, pregnancy, or those taking systemic corticosteroids are unlikely to benefit from the interventions tested in this trial.
Why it matters
Potential benefit: If successful, this approach could reduce pain and disability while improving coping, self-efficacy, and social support for people with chronic low back pain.
How similar studies have performed: Previous trials of biopsychosocial interventions for chronic low back pain have produced mixed but generally promising results for improving function and coping compared with standard physical therapy.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * Diagnosed with non-specific chronic low back pain (pain persisting for more than 12 weeks). * Pain intensity score of ≥3 on the Visual Analog Scale (VAS). * Able to read and understand the study instructions and questionnaires (e.g., SF-36, Oswestry Disability Index). * Not undergoing any current structured physiotherapy or psychological treatment specifically for low back pain. Exclusion Criteria: * o History of specific spinal pathology (e.g., spinal fracture, tumor, infection, or inflammatory diseases like ankylosing spondylitis). * Presence of neurological deficits (e.g., radiculopathy, cauda equina syndrome). * Previous lumbar spine surgery. * Current diagnosis of major psychiatric illness (e.g., severe depression, psychosis) that may interfere with participation. * Pregnancy or within 6 months postpartum. * Ongoing treatment with systemic corticosteroids or other medications affecting musculoskeletal health. * Participation in another clinical trial within the past 3 months. * Any other medical condition deemed by the investigator to contraindicate participation in the study.
Where this trial is running
Lahore, Punjab Province
- University of Lahore — Lahore, Punjab Province, Pakistan (Recruiting)
Study contacts
- Study coordinator: Muhammad Tariq, BSPT, tDPT
- Email: muhammad.tariq@ubas.edu.pk
- Phone: +923454190056
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.