Biopsychosocial Model-based Care Versus Routine Physical Therapy in Chronic Back Pain
NCT07280806 · Status: RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 80
Last updated 2026-03-09
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.
Conditions
- Chronic Low-back Pain (cLBP)
Interventions
- OTHER
-
Biopsychosocial model based care
Participants receive a multimodal physical therapy program integrating physical, psychological, and social dimensions of care. Each session lasts 45 minutes, conducted three times per week for the four weeks. The intervention includes: Baseline modalities: Electrical hot pack (10 min) and TENS (10 min, 80-100 Hz, 100 µs) for pain relief. Manual therapy: Maitland central postero-anterior mobilizations (Grade I-II, 3 × 60 s). Neural mobilization: Sciatic nerve slider, 2 sets × 10 repetitions. Exercise therapy: Abdominal bracing, gluteal activation, graded functional activities, progressed by FITT principles. Psychological education: Cognitive Behavioral Therapy (CBT) and Pain Neuroscience Education (PNE) modules targeting fear-avoidance beliefs, catastrophizing, and maladaptive pain perceptions. Guided imagery and relaxation: Short sessions for body awareness and movement confidence. Social component: Group exercise sessions (3 to 4 participants) to encourage peer interaction.
- OTHER
-
Routine Physical Therapy
Participants in the control group will receive standard physical therapy for chronic low back pain, focusing on pain relief, flexibility, and core/lower limb strengthening. Each session lasts 45 minutes, three times per week for four weeks. Baseline modalities include an electrical hot pack (10 min) and TENS (10 min; 80-100 Hz, 100 µs). Stretching targets the hamstrings, glutei, iliopsoas, and lumbar extensors (20-30 s × 3-5 reps). Strengthening and stabilization involve abdominal bracing, gluteal isometrics, bridging, and planks, progressed per FITT principles (10-15 reps, 40-60% effort). Brief patient education covers ergonomics, posture, activity modification, home exercises, and strategies for managing flare-ups. No psychological or social interventions are included.
Sponsors & Collaborators
-
Lahore University of Biological and Applied Sciences
lead OTHER
Principal Investigators
-
Dr. Faiza Sharif, PhD · University of Lahore
-
Prof. Dr shoaib waqas, PhD · Lahore University of Biological and Applied Sciences
Study Design
- Allocation
- RANDOMIZED
- Purpose
- TREATMENT
- Masking
- TRIPLE
- Model
- PARALLEL
Eligibility
- Min Age
- 25 Years
- Max Age
- 60 Years
- Sex
- ALL
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2025-11-04
- Primary Completion
- 2026-05-15
- Completion
- 2026-06-15
Countries
- Pakistan
Study Locations
More Related Trials
-
Time Course Effects of Functional Resistance Training on Fitness and Quality of Life Chronic Low Back Pain Patients
NCT05449262 ·Status: COMPLETED ·Phase: NA
-
Efficacy of Two Physiotherapy's Approaches in Chronic Low Back Pain: Is Addressing Psychosocial Factors Beneficial?
NCT04979403 ·Status: COMPLETED ·Phase: NA
-
Effects of Core Stabilization Training With and Without Pressure Biofeedback in Patients With Low Back Pain
NCT05021003 ·Status: COMPLETED ·Phase: NA
-
Positional Release Technique Versus Stretching Exercises In Patients With Chronic Non-Specific Low Back Pain
NCT07026071 ·Status: COMPLETED ·Phase: NA
-
Kinetic Control Exercises to Reduce Pain and Improve Balance, Walking, and Stamina in Sacroiliac Joint Issues
NCT07229287 ·Status: COMPLETED ·Phase: NA
-
Post Isometric Relaxation Versus Post Facilitation Stretch Techniques in Chronic Low Back Pain
NCT07026045 ·Status: RECRUITING ·Phase: NA
-
Yoga and Mindfulness for Chronic Low Back Pain: A Randomized Controlled Trial
NCT06910982 ·Status: ENROLLING_BY_INVITATION ·Phase: NA
-
Chiropractic Manipulation and Medical Care for Low Back Pain
NCT01211613 ·Status: COMPLETED ·Phase: NA
-
Physical Activity and Exercise for Disability and Improving Mental Health in Elderly With Chronic Low Back Pain
NCT07178561 ·Status: NOT_YET_RECRUITING ·Phase: NA
-
Standardizing Management of Patients With Low Back Pain in Primary Care and Physical Therapy
NCT00769626 ·Status: TERMINATED ·Phase: PHASE3
-
Effectiveness of Cat-Cow Yoga in Managing Chronic Low Back Pain
NCT04723225 ·Status: COMPLETED ·Phase: NA
-
Chronic Low Back Pain Patients' Expectations Toward Physiotherapy
NCT02123680 ·Status: COMPLETED
-
Psychological Variables in Physiotherapy Treatment of Low Back Pain: A Comparison of Group and Individual Treatment
NCT02138071 ·Status: COMPLETED
-
Efficacy of a Multimodal Physical Activity Intervention in Patients With Chronic Nonspecific Low Back Pain
NCT03200509 ·Status: UNKNOWN ·Phase: NA
-
Combined Effects of Core Stability Exercises and Back Strengthening Exercises on Pregnancy-Induced Back Pain.
NCT06351267 ·Status: COMPLETED ·Phase: NA
-
Comparative Effect of Diaphragmatic Training in Patients With Chronic Non-specific Low Back Pain
NCT07167212 ·Status: WITHDRAWN ·Phase: NA
-
Lumber Stabilization Exercise Versus Back Endurance Exercise Among Female University Students
NCT07163117 ·Status: RECRUITING ·Phase: NA
-
Conventional Exercises Plan With or Without Laser Guided Feedback for Patients With Non-Specific Low Back Pain
NCT06428565 ·Status: ACTIVE_NOT_RECRUITING ·Phase: NA
-
Effect of Multidimensional Physiotherapy in Chronic Nonspecific Low Back Pain
NCT04270422 ·Status: COMPLETED ·Phase: NA
-
Comparison of Moderate Load Eccentric Core Exercises and Pilates in Patients With Non-Specific Low Back Pain
NCT07332390 ·Status: RECRUITING ·Phase: NA
-
Effects of Manual Therapy and Inclined Board Standing on Low Back Pain
NCT05780593 ·Status: COMPLETED ·Phase: NA
-
Effect of Diaphragm Manual Therapy With Conventional Physical Therapy in Chronic Non-Specific Low Back Pain Patients
NCT05299216 ·Status: COMPLETED ·Phase: NA
-
Nature-based Intervention for Chronic Pain in Older People
NCT07002853 ·Status: RECRUITING ·Phase: NA
-
Plyometric Exercise Training in Athletes With Chronic Low Back Pain
NCT06369558 ·Status: COMPLETED ·Phase: NA
-
Bronkow Program and Lumbar Stabilization Exercises in Chronic Non Specific Low Back Pain
NCT06110026 ·Status: RECRUITING ·Phase: NA