NCT07280806 Biopsychosocial Model-based Care Versus Routine Physical Therapy in Chronic Back Pain
| NCT ID | NCT07280806 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Lahore University of Biological and Applied Sciences |
| Condition | Chronic Low-back Pain (cLBP) |
| Study Type | INTERVENTIONAL |
| Enrollment | 80 participants |
| Start Date | 2025-11-04 |
| Primary Completion | 2026-05-15 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
This trial targets 80 participants in total. It began in 2025-11-04 with a primary completion date of 2026-05-15.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
Chronic low back pain (CLBP) is a multifactorial condition influenced by physical, psychological, and social factors. Conventional physical therapy primarily targets biomechanical impairments, often neglecting psychosocial contributors that perpetuate chronic pain and disability. This randomized comparative clinical trial aims to evaluate the effectiveness of Biopsychosocial (BPS) model-based care versus routine physical therapy on pain, disability, psychosocial outcomes, and inflammatory response among adults with CLBP. A total of \_\_\_ participants with CLBP (≥12 weeks) will be randomly allocated into two groups: Routine Physical Therapy Group - receiving baseline hot pack and TENS, stretching (hamstring, gluteal, iliopsoas, and lumbar extensors), and strengthening/stabilization exercises (planks, abdominal bracing, gluteal isometrics, and bridging). BPS Model-Based Care Group - receiving the same baseline treatment plus Maitland mobilization (Grade I-II central PA), sciatic nerve slider, abdominal bracing, graded functional activity, cognitive behavioral therapy (CBT), pain neuroscience education (PNE), guided imagery, and group-based functional exercise therapy. Primary outcome measures include Pain Self-Efficacy, Oswestry Disability Index (ODI), and C-Reactive Protein (CRP). A secondary variable, Perceived Social Support, will assess the social component of recovery. This study hypothesizes that the BPS model-based care will produce superior improvements in pain self-efficacy, functional disability, and inflammatory markers compared to routine therapy, supporting the integration of biopsychosocial rehabilitation in chronic low back pain management.
Eligibility 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.
Contact & Investigator
Dr. Faiza Sharif, PhD
STUDY DIRECTOR
University of Lahore
Frequently Asked Questions
Who can join the NCT07280806 clinical trial?
This trial is open to participants of all sexes, aged 25 Years or older, up to 60 Years, studying Chronic Low-back Pain (cLBP). Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT07280806 currently recruiting?
Yes, NCT07280806 is actively recruiting participants. Contact the research team at muhammad.tariq@ubas.edu.pk for enrollment information.
Where is the NCT07280806 trial being conducted?
This trial is being conducted at Lahore, Pakistan.
Who is sponsoring the NCT07280806 clinical trial?
NCT07280806 is sponsored by Lahore University of Biological and Applied Sciences. The principal investigator is Dr. Faiza Sharif, PhD at University of Lahore. The trial plans to enroll 80 participants.