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Chronic Low-back Pain (cLBP)NCT07280806

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

A study testing Biopsychosocial model based care and Routine Physical Therapy in people with Chronic Low-back Pain (cLBP), run by Lahore University of Biological and Applied Sciences at 1 site in Pakistan.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 25 to 60 years
Conditions the study is for
Chronic Low-back Pain (cLBP)
What is being tested?
Biopsychosocial model based care and Routine Physical Therapy
Could I receive a placebo?
No, everyone receives an active treatment
How many people
80 participants
Where
1 sitePakistan
Study dates
4 Nov 2025to 15 May 2026
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 25 to 60 years
  • All sexes
  • No healthy volunteers
  • Adult

Who may be able to join

  • 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.

Who cannot join

  • 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.

Trial locations and contacts

1 site in 1 country.

Pakistan1 site
  • University of Lahore

    Lahore, Punjab Province, 05450

Other trials in Pakistan

About this study

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:

Read more

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.

Read the 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.

Being tested
Biopsychosocial model based care, Routine Physical Therapy
Keywords
Biopsychosocial model based care, Routine Physical therapy, Chronic Low back pain

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Biopsychosocial model based careOther

    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.

  • Routine Physical TherapyOther

    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.

Study groups in NCT07280806
Study groupRoleWhat they receive
Group A (Biopsychosocial group)ExperimentalParticipants 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.
Receives: Other: Biopsychosocial model based care
Group B ( Routine Physical Therapy)Active comparatorParticipants 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.
Receives: Other: Routine Physical Therapy

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. 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)

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

  2. 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.

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

Secondary outcomes (4)
  1. 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.

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

  2. 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)

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

  3. 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.

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

  4. 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

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

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted12 Dec 2025
  2. Study start4 Nov 2025
  3. Primary completion15 Feb 2026
  4. Study completion15 May 2026

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Triple blind
Who is masked
Participant, Investigator, Outcomes assessor
Enrolment
80 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT07280806
Sponsor's protocol ID
UOL/IREB/25/12/00010
Status last verified
Jun 2026
First submitted
19 Nov 2025
Last updated
12 Jun 2026
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
Yes: baseline participants

Publications

  • Tariq M, Sharif F, Ahmad A, Waqas S, Hussain SI, Mehboob A. Effectiveness of Biopsychosocial Model-Based Care versus Routine Physical Therapy on Clinical, Sensorimotor, and Psychosocial Outcomes in Patients with Chronic Low Back Pain: A Randomized Clinical Trial. J Pain Res. 2026 Oct 3;19:628766. doi: 10.2147/JPR.S628766. eCollection 2026.

    PubMed 42846470

Questions about this trial

What is this clinical trial studying?

A study testing Biopsychosocial model based care and Routine Physical Therapy in people with Chronic Low-back Pain (cLBP), run by Lahore University of Biological and Applied Sciences at 1 site in Pakistan.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 4 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 12 Jun 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Pakistan. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Pain Intensity (time frame: Baseline (pre-intervention), 4 weeks (post-intervention), and 8 weeks (follow-up)). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT07280806, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 12 Jun 2026.

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