Ignite Creation Date:
2025-12-26 @ 4:02 PM
Ignite Modification Date:
2026-01-04 @ 8:38 AM
Study NCT ID:
NCT07280806
Status:
RECRUITING
Last Update Posted:
2025-12-12
First Post:
2025-11-19
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Biopsychosocial Model-based Care Versus Routine Physical Therapy in Chronic Back Pain
Sponsor:
Lahore University of Biological and Applied Sciences
Organization:
Study Overview
Official Title:
Biopsychosocial Model-based Care Versus Routine Physical Therapy in Chronic Back Pain
Status:
RECRUITING
Status Verified Date:
2025-12
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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.
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.
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 Oversight
Has Oversight DMC:
False
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: