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

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.

Study Overview

• Status: Recruiting
• Conditions: Chronic Low-back Pain (cLBP)
• Intervention / Treatment: Other: Biopsychosocial model based care; Other: Routine Physical Therapy

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.

• Study Type: Interventional
• Enrollment (Estimated): 80
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Muhammad Tariq, BSPT, tDPT; Phone Number: +923454190056; Email: muhammad.tariq@ubas.edu.pk

Study Locations

• Pakistan
  • Punjab Province
    • Lahore, Punjab Province, Pakistan, 05450
      • Recruiting
      • University of Lahore
      • Contact: Muhammad Tariq, BSPT, tDPT; Phone Number: 03454190056; Email: muhammad.tariq@ubas.edu.pk

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult
• Accepts Healthy Volunteers: No

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Triple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: 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.	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.
Active Comparator: 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.	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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Pain Intensity	Measured using the Short-Form McGill Pain Questionnaire-2 (Short-Form McGill Pain Questionnaire Version 2), which evaluates sensory and affective dimensions of pain in individuals with chronic low back pain. The scale uses 22 items rated from 0 to 10, where 0 indicates "no pain" and 10 indicates "worst possible pain." The final score is the mean of all items, with higher scores representing worse pain. The instrument demonstrates excellent internal consistency (Cronbach's α = 0.89-0.91)	Baseline (pre-intervention), 4 weeks (post-intervention), and 8 weeks (follow-up)
Functional Disability	Disability will be assessed using the Oswestry Disability Index , a 10-item questionnaire that measures functional limitations and activity restrictions related to chronic low back pain. Each item is scored on a 6-point scale from 0 to 5, giving a total possible score range of 0 to 50. The total score is then converted to a percentage (0%-100%), where higher scores indicate worse disability. The ODI demonstrates high reliability, with Cronbach's alpha values reported between 0.86 and 0.94.	Baseline (pre-intervention), 4 weeks (post-intervention), and 8 weeks (follow-up)

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Perceived Social Support	Perceived social support will be measured using the Multidimensional Scale of Perceived Social Support. This is a 12-item scale with responses scored on a 7-point Likert format ranging from 1 to 7, where 1 = Very strongly disagree and 7 = Very strongly agree. The total MSPSS score ranges from 12 to 84, and subscale scores (Family, Friends, Significant Others) range from 4 to 28. Higher scores indicate better (greater) perceived social support. The scale has demonstrated strong internal consistency, with Cronbach's alpha values 0.88-0.93.	Baseline (pre-intervention), 4 weeks (post-intervention), and 8 weeks (follow-up)
Lumbar Core Muscle Control:	Measure Description: Lumbar core muscle control is evaluated using a Pressure Biofeedback Unit (PBU) to assess the motor control and activation of the deep abdominal musculature, specifically the transversus abdominis. Following the protocol by Richardson and Jull (1995), participants are positioned in a crook-lying posture with the PBU cuff placed under the lumbar spine and inflated to a baseline of 40 mmHg. Participants perform the abdominal drawing-in maneuver (ADIM) while maintaining steady breathing. A successful activation is defined as a controlled pressure reduction of 4-10 mmHg. Greater accuracy and the ability to sustain this pressure change reflect superior muscle control. The PBU demonstrates high reliability with ICC values between 0.81 and 0.93.	Baseline (pre-intervention), 4 weeks (post-intervention), and 8 weeks (follow-up)
Pain Self-Efficacy	Evaluated using the Pain Self-Efficacy Questionnaire (Pain Self-Efficacy Questionnaire, which measures an individual's confidence in performing daily activities despite pain. The scale contains 10 items scored from 0 ("not at all confident") to 6 ("completely confident"), resulting in a total score range of 0 to 60. Higher scores indicate greater pain self-efficacy. The instrument demonstrates excellent reliability in musculoskeletal populations (Cronbach's α = 0.92)	Baseline (pre-intervention), 4 weeks (post-intervention), and 8 weeks (follow-up)
Health-Related Quality of Life (SF-36)	Measure Description: Quality of life is assessed using the Short Form-36 Health Survey (SF-36) across eight domains: physical functioning, role limitations (physical/emotional), bodily pain, general health, vitality, social functioning, and mental health. Scores are transformed to a 0-100 scale, where higher scores represent better perceived health-related quality of life	Baseline (pre-intervention), 4 weeks (post-intervention), and 8 weeks (follow-up)

Collaborators and Investigators

• Sponsor: Lahore University of Biological and Applied Sciences
• Investigators: Study Director: Dr. Faiza Sharif, PhD, University of Lahore; Study Chair: Prof. Dr shoaib waqas, PhD, Lahore University of Biological and Applied Sciences

Study record dates

Study Major Dates

• Study Start (Actual): November 4, 2025
• Primary Completion (Estimated): May 15, 2026
• Study Completion (Estimated): June 15, 2026

Study Registration Dates

• First Submitted: November 19, 2025
• First Submitted That Met QC Criteria: December 10, 2025
• First Posted (Actual): December 12, 2025

Study Record Updates

• Last Update Posted (Actual): March 9, 2026
• Last Update Submitted That Met QC Criteria: March 5, 2026
• Last Verified: March 1, 2026

More Information

Terms related to this study

• Keywords: Chronic Low back pain; Biopsychosocial model based care; Routine Physical therapy
• Other Study ID Numbers: UOL/IREB/25/12/00010

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: baseline participants

IPD Sharing Time Frame

Start Date: The de-identified individual participant data (IPD) and supporting information will be available after publication of the primary trial results, expected approximately 12 months after trial completion.

End Date: Access will remain available for 5 years from the start date to qualified researchers who submit a formal request and agree to the data use terms.

IPD Sharing Access Criteria

De-identified individual participant data (IPD) and supporting information will be available to qualified researchers for academic, non-commercial purposes. Researchers must submit a written request outlining the research objectives and intended use of the data. Requests will be reviewed by the principal investigator (Dr. Muhammad Tariq Shafi) and the institutional ethics committee to ensure appropriate use and participant privacy.

Data Available:

The shared dataset will include de-identified information on:

Demographics (age, sex)

Pain intensity (SF-MPQ-2)

Disability (ODI)

Pain self-efficacy (PSEQ)

Perceived social support (MSPSS)

Exercise adherence (EARS)

Serum C-Reactive Protein (CRP) levels

Supporting documents will include the study protocol, statistical analysis plan, and data dictionary to facilitate accurate interpretation.

Access Method:

Approved researchers will receive the dataset and supporting materials via secure institutional file transfer or password-protected

• IPD Sharing Supporting Information Type: STUDY_PROTOCOL; SAP; ICF; CSR

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No