Effectiveness of Pain Neuroscience Education Combined With Therapeutic Exercise in People With Chronic Pain
试验速览
- 阶段
- 不适用
- 状态
- Enrolling By Invitation
- 入组人数
- 84
- 试验地点
- 1
- 主要终点
- Level of physical activity
研究概览
简要总结
Chronic pain is an unpleasant sensory and emotional experience associated with actual or potential tissue damage, with a high prevalence in Spain (25.9%) and an average duration of 6.83 years, highlighting its significant health and social impact. Among its manifestations, chronic low back pain (CLBP) is the most common, affecting 58.1% of individuals with chronic pain, while fibromyalgia (FM) accounts for 10.4%. In both cases, a relevant proportion of patients do not present a clear organic cause, which complicates diagnosis and treatment and reflects the complexity of nonspecific chronic pain.
CLBP is associated with a high functional and occupational impact, being one of the main causes of temporary disability. FM, on the other hand, is characterized by widespread musculoskeletal pain accompanied by fatigue, sleep disturbances, and emotional symptoms, constituting a condition with systemic involvement. Both conditions can occur throughout the lifespan, with variations in prevalence depending on age, sex, social class, and the presence of comorbidities.
Aging introduces relevant differences in pain experience and treatment response. At the physiological level, changes occur in the musculoskeletal system, such as the progressive loss of muscle mass (especially type II fibers) and decreased bone mineral density, which increases the risk of sarcopenia and frailty. In contrast, young adults show greater anabolic capacity, better hypertrophic response, and higher neuromuscular efficiency, favoring faster adaptations to exercise. These differences justify the need to consider age as a key factor in the therapeutic approach.
In addition to structural changes, central sensitization plays a fundamental role in the chronification of pain. This process involves sustained hyperexcitability of the central nervous system, with a reduced pain threshold and altered inhibitory mechanisms, contributing to the persistence of pain even in the absence of significant tissue damage.
Therapeutic exercise (TE) is one of the main non-pharmacological interventions for chronic pain and has demonstrated effectiveness in reducing pain and improving functionality. However, its long-term effects are limited, largely due to adherence issues related to pain, as well as psychological, social, and educational factors. Educational level influences both the understanding of the intervention and adherence, generally being higher in young adults, which may affect treatment outcomes.
In this context, Pain Neuroscience Education (PNE) has emerged as a complementary strategy aimed at improving understanding of pain mechanisms and promoting adaptive behavioral changes. The combination of PNE and TE has shown positive effects in patients with CLBP and FM, especially in variables related to pain and psychosocial factors.
However, there is a lack of evidence regarding the impact of this combination on objective functional parameters, such as spinal movement during functional activities. Therefore, it is necessary to investigate the effectiveness of the combined intervention of PNE and TE not only on pain but also on biomechanical variables such as range, velocity, and quality of movement, using precise measurement instruments.
详细描述
This study aims to evaluate the effectiveness of Pain Neuroscience Education (PNE) combined with Therapeutic Exercise (TE) in individuals with chronic low back pain (CLBP) and fibromyalgia (FM). Chronic pain conditions are frequently associated with maladaptive pain beliefs, pain catastrophizing, central sensitization, and functional limitations. PNE has been proposed as an educational approach to improve patients' understanding of pain mechanisms and promote adaptive coping strategies, potentially enhancing the effects of exercise-based interventions.
The study is designed as a randomized controlled clinical trial including participants with either CLBP or FM. Participants will be stratified according to age (<65 years and ≥65 years) and clinical condition (CLBP or FM) and then randomly assigned to one of two intervention groups: (1) PNE combined with TE, or (2) placebo education combined with the same TE program.
The intervention period will last eight weeks. All participants will perform a standardized therapeutic exercise program focused on physical function and movement. Participants allocated to the experimental group will additionally receive PNE sessions addressing contemporary pain neuroscience concepts, including pain mechanisms, central sensitization, the influence of psychosocial factors, fear of movement, and self-management strategies. Participants in the control group will receive placebo educational sessions focused on anatomy and biomechanics, matched for duration and attention.
Assessments will be conducted at baseline, immediately after the intervention, and during follow-up periods at 4, 12, and 24 weeks after treatment completion. The study will examine changes in pain-related, psychological, sensory, and functional outcomes over time and compare responses between clinical conditions and age groups.
The results of this study may contribute to understanding the added value of PNE when combined with therapeutic exercise and whether age and clinical diagnosis influence treatment response in individuals with chronic pain.
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
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Fibromyalgia (FM)
- •Inclusion Criteria:
- •Diagnosis of fibromyalgia according to the 2010/2011 American College of -Rheumatology criteria
- •Ability to understand and follow study instructions (Mini-Mental State Examination [MMSE] score >23)
排除标准
- •Changes in medication during the month prior to enrollment
- •Disorders affecting the central or peripheral nervous system
- •Chronic Low Back Pain (CLBP)
- •Inclusion Criteria:
- •Chronic low back pain lasting at least 3 months
- •Low back pain occurring on 3 or more days per week
- •Pain located between the lower rib margin and the gluteal folds
- •Ability to understand and follow study instructions (Mini-Mental State Examination [MMSE] score >23)
- •Exclusion Criteria:
- •Changes in medication during the month prior to enrollment
- •Disorders affecting the central or peripheral nervous system
- •History of spinal surgery
研究组 & 干预措施
EG Fibromyalgia
Fibromyalgia Intervention Group: Exercise and Pain Education
干预措施: Therapeutic Exercise and Education in Pain Neuroscience (Other)
CG Fibromyalgia
Fibromyalgia Control Group: Exercise and Placebo Education
干预措施: Therapeutic exercise and education in the neuroscience of pain: the placebo effect (Other)
EG Chronic Low Back Pain
Experimental Group for Chronic Low Back Pain: Exercise and Pain Education
干预措施: Therapeutic Exercise and Education in Pain Neuroscience (Other)
CG Chronic Low Back Pain
Experimental Group for Chronic Low Back Pain: Exercise and Placebo Education
干预措施: Therapeutic exercise and education in the neuroscience of pain: the placebo effect (Other)
结局指标
主要结局
Level of physical activity
时间窗: Before the procedure, after the procedure, one month later, three months later, and six months later the procedure.
Using the International Physical Activity Questionnaire (IPAQ). Scores are expressed in MET-minutes/week. Higher scores indicate higher levels of physical activity and a better outcome.
Central level of awareness
时间窗: Before the procedure, after the procedure, one month later, three months later, and six months later the procedure.
Using the Central Sensitization Inventory (CSI). Total score ranges from 0 to 100. Higher scores indicate greater symptoms related to central sensitization and a worse outcome.
Pain on movement
时间窗: Before the procedure, after the procedure, one month later, three months later, and six months later the procedure.
Pain using the Visual Analogue Scale (VAS): Scores range from 0 to 10, with higher scores indicating greater pain intensity and a worse outcome.
Level of catastrophizing
时间窗: Before the procedure, after the procedure, one month later, three months later, and six months later the procedure.
Level of catastrophizing using the Pain Catastrophizing Scale (PCS). Total score ranges from 0 to 52. Higher scores indicate greater pain catastrophizing and a worse outcome.
Functionality - Lumbar movements
时间窗: Before the procedure, after the procedure, one month later, three months later, and six months later the procedure.
Using a motion capture system. Each movement is performed 5 times (the middle 3 repetitions will be analyzed). In all cases, pain will be assessed using a visual analog scale ranging from 0 to 10. Thirty-six markers will be placed throughout the body, except on the hands. The tests measured using the motion capture system will be: lumbar flexion-extension, rotations, and lateral bending.
Functionality - The 5 Time Sit to Stand Test
时间窗: Before the procedure, after the procedure, one month later, three months later, and six months later the procedure.
Using a motion capture system. Each movement is performed 5 times (the middle 3 repetitions will be analyzed). In all cases, pain will be assessed using a visual analog scale ranging from 0 to 10. Thirty-six markers will be placed throughout the body, except on the hands. The test measured using the motion capture system will be the 5-Time Sit-to-Stand Test. he outcome is the time required to complete five consecutive sit-to-stand repetitions, measured in seconds. Scores range from 0 seconds to no theoretical maximum. Higher scores indicate poorer lower-limb functional performance and a worse outcome.
Functionality - Lifting a 5 kg ball off the floor
时间窗: Before the procedure, after the procedure, one month later, three months later, and six months later the procedure.
Using a motion capture system. Each movement is performed 5 times (the middle 3 repetitions will be analyzed). In all cases, pain will be assessed using a visual analog scale ranging from 0 to 10. Thirty-six markers will be placed throughout the body, except on the hands. The test measured using the motion capture system will be lifting a 5 kg ball from the floor in a free-standing position, in a deadlift and in a squat.
Degree of disability
时间窗: Before the procedure, after the procedure, one month later, three months later, and six months later the procedure.
Using the Oswestry Disability Index (ODI): Scores range from 0 to 100%, with higher scores indicating greater disability and a worse outcome.
Conditioned Sensitivity Test
时间窗: Before the procedure, after the procedure, one month later, three months later, and six months later the procedure.
Test to assess the condition of the nervous system. The test stimulus is applied using an algometer, and the pressure pain threshold is assessed on the tibialis anterior muscle (5 cm distal to the tibial tuberosity). The patient verbally reports the point at which pressure becomes painful (the average of three consecutive measurements is calculated). Next, a conditioning stimulus is applied using a blood pressure cuff at a constant pressure of 240 mmHg for 120 seconds. Finally, the pressure pain threshold in the tibialis anterior is assessed.
Biering-Sörensen Test
时间窗: Before the procedure, after the procedure, one month later, three months later, and six months later the procedure.
This is a functional test of the lumbar spine used to measure the isometric strength and endurance of the trunk extensor muscles, particularly in the lumbar spine. This test is measured using surface electromyography (EMG), and the electrodes-which are 20 mm in size-should be placed on the iliocostalis muscle 3-4 cm lateral to the midline and at the level of L2-L4.
次要结局
- Anthropometric data - Weigth(Before the procedure, after the procedure, one month later, three months later, and six months later the procedure.)
- Demographic data - Age(Before the procedure, after the procedure, one month later, three months later, and six months later the procedure.)
- Anthropometric data - Body Mass Index (BMI)(Before the procedure, after the procedure, one month later, three months later, and six months later the procedure.)
- Demographic data - Gender(In the initial valuation.)
- Sensitivity(Before the procedure, after the procedure, one month later, three months later, and six months later the procedure.)
- Anxiety and depression(Before the procedure, after the procedure, one month later, three months later, and six months later the procedure.)
- Kinesiophobia(Before the procedure, after the procedure, one month later, three months later, and six months later the procedure.)
- Fibromyalgia Index(Before the procedure, after the procedure, one month later, three months later, and six months later the procedure.)
研究者
Pilar Serra Añó
Full Professor
University of Valencia