Biopsychosocial Model-based Care Versus Routine Physical Therapy in Chronic Back Pain

NCT ID: NCT07280806

Last Updated: 2025-12-12

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: NA
• Total Enrollment: 80 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2025-11-04
• Study Completion Date: 2026-06-15

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.

Detailed Description

Chronic low back pain (CLBP) is a complex and persistent condition with multifactorial origins involving physical, psychological, and social dimensions. Traditional physiotherapy management typically emphasizes biomechanical correction through exercises and modalities; however, recent evidence underscores the significant contribution of psychosocial factors-such as maladaptive beliefs, fear-avoidance behaviors, and low self-efficacy-in the persistence of pain and disability. The biopsychosocial (BPS) model of care integrates these dimensions to promote holistic recovery and long-term functional improvement.

This randomized comparative clinical trial aims to determine the effectiveness of BPS model-based care versus routine physical therapy on pain self-efficacy, disability, inflammatory status, and perceived social support in individuals with CLBP. A total of ___ participants meeting the inclusion criteria (age 25-60 years, pain duration ≥12 weeks) will be recruited and randomly assigned into two equal groups.

The Routine Physical Therapy Group will receive:

Baseline care: Moist hot pack and Transcutaneous Electrical Nerve Stimulation (TENS)

Stretching of hamstrings, glutei, iliopsoas, and lumbar extensors

Strengthening/stabilization: abdominal bracing, planks, gluteal isometrics, and bridging exercises

The BPS Model-Based Care Group will receive:

The same baseline treatment as the control group

Maitland mobilization (Grade I-II central posteroanterior)

Sciatic nerve slider

Abdominal bracing and graded functional activities

Cognitive Behavioral Therapy (CBT) sessions focusing on fear-avoidance and coping skills

Pain Neuroscience Education (PNE)

Guided imagery and group exercise therapy to enhance engagement and motivation

Interventions will be administered three times per week for 6 weeks under physiotherapist supervision.

Outcome Measures:

Primary outcomes will include Pain Self-Efficacy (PSEQ), Oswestry Disability Index (ODI), and C-Reactive Protein (CRP) as a biochemical indicator of systemic inflammation. Perceived Social Support (Multidimensional Scale of Perceived Social Support) will be evaluated as a secondary variable reflecting the social dimension of recovery.

Assessments will be conducted at baseline and after 6 weeks of intervention. Data will be analyzed using appropriate statistical tests to compare within- and between-group changes.

This study will provide evidence on the role of integrated biopsychosocial rehabilitation in improving physical, psychological, and social outcomes in chronic low back pain, potentially guiding future physiotherapy practice toward a more holistic model of patient-centered care.

Conditions

Chronic Low-back Pain (cLBP)

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: TRIPLE

Study Groups

Group A (Biopsychosocial group)

Participants allocated to the Biopsychosocial Model-Based Care group will receive a structured, multimodal physical therapy program that integrates physical, psychological, and social components of rehabilitation. The protocol is designed to address not only musculoskeletal impairments but also cognitive, emotional, and behavioral factors that influence chronic low back pain (CLBP).

Each session will last approximately 45 minutes, conducted three times per week for the four weeks under the supervision of a licensed physiotherapist trained in the BPS approach.

Group Type: EXPERIMENTAL

Biopsychosocial model based care

Intervention Type: OTHER

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.

Group B ( Routine Physical Therapy)

Participants in the Routine Physical Therapy group will receive a standardized physical therapy program designed to address the physical and functional components of chronic low back pain (CLBP). This approach represents standard clinical practice focused primarily on pain reduction, muscle flexibility, and core stabilization, without formal incorporation of psychological or social interventions.

Each treatment session will last 45 minutes, administered three times per week for the 4 weeks by a qualified physiotherapist.

Group Type: ACTIVE_COMPARATOR

Routine Physical Therapy

Intervention Type: OTHER

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.

Interventions

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.

Intervention Type: 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.

Intervention Type: OTHER

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.

• Minimum Eligible Age: 25 Years
• Maximum Eligible Age: 60 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Lahore University of Biological and Applied Sciences

OTHER

Sponsor Role: lead

Responsible Party

Muhammad Tariq

Dr. Muhammad Tariq Shafi

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Dr. Faiza Sharif, PhD

Role: STUDY_DIRECTOR

University of Lahore

Prof. Dr shoaib waqas, PhD

Role: STUDY_CHAIR

Lahore University of Biological and Applied Sciences

Locations

University of Lahore

Lahore, Punjab Province, Pakistan

Site Status: RECRUITING

Countries

Pakistan

Central Contacts

Muhammad Tariq, BSPT, tDPT

Role: CONTACT

muhammad.tariq@ubas.edu.pk

+923454190056

Facility Contacts

Muhammad Tariq, BSPT, tDPT

Role: primary

muhammad.tariq@ubas.edu.pk

03454190056

Other Identifiers

UOL/IREB/25/12/00010

Identifier Type: -

Identifier Source: org_study_id