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

NCT07280806 | Recruiting

• 1 other identifier: UOL/IREB/25/12/00010
• Study Type: interventional
• Target: 80
• Locations: 1 country
• Sites: 1

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.

Conditions

Chronic Low-back Pain (cLBP)

Keywords

Biopsychosocial model based care; Routine Physical therapy; Chronic Low back pain

Outcome Measures

Primary Outcomes (2)

• 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 Outcomes (4)

• Lumbar Core Muscle Control:

  Baseline (pre-intervention), 4 weeks (post-intervention), and 8 weeks (follow-up)

• Pain Self-Efficacy

  Baseline (pre-intervention), 4 weeks (post-intervention), and 8 weeks (follow-up)

• Perceived Social Support

  Baseline (pre-intervention), 4 weeks (post-intervention), and 8 weeks (follow-up)

• Health-Related Quality of Life (SF-36)

  Baseline (pre-intervention), 4 weeks (post-intervention), and 8 weeks (follow-up)

Study Arms (2)

Group A (Biopsychosocial group)

EXPERIMENTAL

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

Group B ( Routine Physical Therapy)

ACTIVE COMPARATOR

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

Interventions

Biopsychosocial model based care 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 A (Biopsychosocial group)

Routine Physical Therapy 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.

Group B ( Routine Physical Therapy)

Eligibility Criteria

• Age: 25 Years - 60 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Lahore University of Biological and Applied Sciences: lead

Study Sites (1)

University of Lahore

Lahore, Punjab Province, 05450, Pakistan

RECRUITING

Study Officials

• Dr. Faiza Sharif, PhD

  University of Lahore

  STUDY DIRECTOR

• Prof. Dr shoaib waqas, PhD

  Lahore University of Biological and Applied Sciences

  STUDY CHAIR

Central Study Contacts

Muhammad Tariq, BSPT, tDPT

CONTACT

+923454190056; muhammad.tariq@ubas.edu.pk

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Dr. Muhammad Tariq Shafi

Study Record Dates

• First Submitted: November 19, 2025
• First Posted: December 12, 2025
• Study Start: November 4, 2025
• Primary Completion (Estimated): May 15, 2026
• Study Completion (Estimated): June 15, 2026
• Last Updated: March 9, 2026

Record last verified: 2026-03

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF, CSR
• 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.
• 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

Locations

PA (1)