Chronic Low-back Pain (cLBP)
Conditions
Keywords
Biopsychosocial model based care, Routine Physical therapy, Chronic Low back pain
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.
Interventions
OTHERBiopsychosocial 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.
OTHERRoutine 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
Lahore University of Biological and Applied Sciences
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
TRIPLE (Subject, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
25 Years to 60 Years
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Pain Intensity | Baseline (pre-intervention), 4 weeks (post-intervention), and 8 weeks (follow-up) | 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) |
| Functional Disability | Baseline (pre-intervention), 4 weeks (post-intervention), and 8 weeks (follow-up) | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Lumbar Core Muscle Control: | Baseline (pre-intervention), 4 weeks (post-intervention), and 8 weeks (follow-up) | 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. |
| Pain Self-Efficacy | Baseline (pre-intervention), 4 weeks (post-intervention), and 8 weeks (follow-up) | 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) |
| Perceived Social Support | Baseline (pre-intervention), 4 weeks (post-intervention), and 8 weeks (follow-up) | 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. |
| Health-Related Quality of Life (SF-36) | Baseline (pre-intervention), 4 weeks (post-intervention), and 8 weeks (follow-up) | 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 |
Countries
Pakistan
Contacts
STUDY_DIRECTORDr. Faiza Sharif, PhD
University of Lahore
STUDY_CHAIRProf. Dr shoaib waqas, PhD
Lahore University of Biological and Applied Sciences
Outcome results
None listed