Biopsychosocial Model-based Care Versus Routine Physical Therapy in Chronic Back Pain (NCT07280806) | Clinical Trial Compass
CompletedNot Applicable
Biopsychosocial Model-based Care Versus Routine Physical Therapy in Chronic Back Pain
Pakistan80 participantsStarted 2025-11-04
Plain-language 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.
Who can participate
Age range
25 Years – 60 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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.
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1This trial compared a biopsychosocial model-based approach to routine physical therapy for chronic low back pain — can you explain what 'biopsychosocial' means in practice, and whether addressing the psychological and social factors alongside the physical ones might be relevant to my situation?
2Since this trial has already been completed, have any results been published yet, and if so, did the biopsychosocial approach show meaningful improvements in pain intensity or functional disability compared to standard physical therapy?
3Given that this study measured both pain levels and functional disability as its main outcomes, which of those two issues is more of a priority for my care, and does that affect which type of treatment approach might suit me better?
4This trial used a non-standard care model rather than a conventional physical therapy program — is biopsychosocial-based care something that's currently available to me, or would I need to seek out a specialist or specific clinic to access it?
5Before considering a specialized approach like the one studied in this trial, would it make sense to first try or continue with routine physical therapy, and how would we decide together if it's time to explore something different?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Pain Intensity
Timeframe: Baseline (pre-intervention), 4 weeks (post-intervention), and 8 weeks (follow-up)
2
Functional Disability
Timeframe: Baseline (pre-intervention), 4 weeks (post-intervention), and 8 weeks (follow-up)
Trial details
NCT IDNCT07280806
SponsorLahore University of Biological and Applied Sciences