Biopsychosocial Model-based Care Versus Routine Physical Therapy in Chronic Back Pain
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 80
- 试验地点
- 1
- 主要终点
- Pain Intensity
研究概览
简要总结
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.
详细描述
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
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Triple (Participant, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 25 Years 至 60 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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.
排除标准
- •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.
研究组 & 干预措施
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.
干预措施: Biopsychosocial model based care (Other)
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.
干预措施: Routine Physical Therapy (Other)
结局指标
主要结局
Pain Intensity
时间窗: 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
时间窗: 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.
次要结局
- 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))
研究者
Muhammad Tariq
Dr. Muhammad Tariq Shafi
University of Lahore