The Effect of Pain Neuroscience Education Added to Aerobic Exercise on Pain, Symptom Severity, and Cortisol Levels in Patients With Irritable Bowel Syndrome
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 入组人数
- 33
- 试验地点
- 1
- 主要终点
- Abdominal Pain Intensity (Numeric Pain Rating Scale)
研究概览
简要总结
Irritable Bowel Syndrome (IBS) is a chronic disorder of gut-brain interaction characterized by abdominal pain and changes in bowel habits. The aim of this study is to compare the effects of moderate-intensity aerobic exercise alone and aerobic exercise combined with Pain Neuroscience Education on abdominal pain, IBS symptom severity, quality of life, and salivary cortisol levels in individuals with IBS.
Participants will be randomly allocated into three groups: (1) Aerobic Exercise Group, (2) Aerobic Exercise plus Pain Neuroscience Education Group, and (3) Control Group. The aerobic exercise program will consist of supervised walking sessions performed twice weekly for six weeks. Pain Neuroscience Education will be delivered in short, structured sessions over the same six-week period. Assessments will be conducted at baseline and at the end of the intervention. Primary outcomes include abdominal pain intensity, IBS symptom severity, and salivary cortisol levels. Secondary outcomes include quality of life, stool form, and pain-related psychosocial measures. This study aims to provide evidence for non-pharmacological, biopsychosocial approaches in the management of IBS.
详细描述
This is a single-center, randomized controlled interventional study designed to investigate the added effects of Pain Neuroscience Education (PNE) to aerobic exercise on abdominal pain, symptom severity, and stress-related biological responses in individuals with Irritable Bowel Syndrome (IBS).
IBS is a multifactorial disorder of gut-brain interaction characterized by visceral hypersensitivity, central sensitization, and dysregulation of stress-response systems, particularly the hypothalamic-pituitary-adrenal (HPA) axis. Given the heterogeneous nature of IBS and the limited long-term effectiveness of pharmacological treatments, there is increasing interest in non-pharmacological, biopsychosocial approaches that target both physiological and cognitive-behavioral mechanisms.
Aerobic exercise has been shown to modulate autonomic nervous system activity, inflammatory processes, and stress regulation, which are relevant to IBS symptom expression. Pain Neuroscience Education is a structured educational intervention aimed at reducing perceived threat associated with pain by improving understanding of pain neurophysiology, addressing central sensitization mechanisms, and modifying maladaptive beliefs and avoidance behaviors. The integration of aerobic exercise with PNE is hypothesized to produce more comprehensive and sustainable clinical benefits than exercise alone by simultaneously targeting peripheral, central, and cognitive components of pain.
Adults aged 18-65 years diagnosed with IBS according to Rome IV criteria will be recruited. Participants will be stratified by IBS subtype and sex before being randomly allocated into three study groups.
The aerobic exercise intervention will consist of supervised walking sessions conducted in accordance with the American College of Sports Medicine (ACSM) guidelines. Exercise intensity will be prescribed using the Karvonen heart rate reserve method, targeting 40-59% of heart rate reserve, with progression based on individual tolerance over the six-week intervention period.
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
- None
入排标准
- 年龄范围
- 18 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Adults aged between 18 and 65 years
- •Diagnosis of Irritable Bowel Syndrome according to Rome IV criteria
- •Presence of abdominal pain for at least the past 3 months
- •Ability to understand and follow study instructions
- •Willingness to participate in the exercise and education sessions
- •Provision of written informed consent
排除标准
- •Presence of organic gastrointestinal diseases (e.g., inflammatory bowel disease, celiac disease)
- •History of gastrointestinal surgery affecting bowel function
- •Severe cardiovascular, neurological, or musculoskeletal conditions contraindicating aerobic exercise
- •Current participation in a structured exercise program
- •Use of medications that may significantly affect gastrointestinal motility or pain perception
- •Pregnancy
- •Cognitive impairment as indicated by Mini-Mental State Examination score below the cutoff value
- •Any medical condition deemed by the investigators to interfere with safe participation in the study
研究组 & 干预措施
Aerobic Exercise Group
Participants in this group will receive a supervised moderate-intensity aerobic exercise program designed according to the American College of Sports Medicine (ACSM) guidelines. The program will consist of treadmill-based walking sessions performed twice weekly for six weeks. Exercise intensity will be set at 40-59% of Heart Rate Reserve using the Karvonen method, and session duration will be progressively increased.
干预措施: Exercise (Behavioral)
Aerobic Exercise plus Pain Neuroscience Education Group
Participants in this group will receive the same aerobic exercise program as the Aerobic Exercise Group. In addition, structured Pain Neuroscience Education sessions will be delivered over a six-week period. The education will address pain neurophysiology, central sensitization, stress responses, safety cues, and cognitive-behavioral strategies aimed at reducing perceived threat related to pain and enhancing engagement in physical activity.
干预措施: Exercise (Behavioral)
Aerobic Exercise plus Pain Neuroscience Education Group
Participants in this group will receive the same aerobic exercise program as the Aerobic Exercise Group. In addition, structured Pain Neuroscience Education sessions will be delivered over a six-week period. The education will address pain neurophysiology, central sensitization, stress responses, safety cues, and cognitive-behavioral strategies aimed at reducing perceived threat related to pain and enhancing engagement in physical activity.
干预措施: Pain Neuroscience Education (Behavioral)
Control Group
Participants in the control group receive standard care and are provided with an informational brochure containing general information related to the condition. No structured exercise program or educational intervention is delivered during the study period.
结局指标
主要结局
Abdominal Pain Intensity (Numeric Pain Rating Scale)
时间窗: Baseline and at the end of the 6-week intervention period
Abdominal pain intensity is assessed using the Numeric Pain Rating Scale, where participants rate their average abdominal pain intensity over the previous week on an 11-point scale ranging from 0 (no pain) to 10 (worst imaginable pain). Higher scores indicate greater pain intensity.
IBS Symptom Severity (Irritable Bowel Syndrome Symptom Severity Score)
时间窗: Baseline and at the end of the 6-week intervention period
IBS symptom severity will be assessed using the Irritable Bowel Syndrome Symptom Severity Score (IBS-SSS). This validated questionnaire consists of five items evaluating abdominal pain severity, abdominal pain frequency, abdominal bloating, dissatisfaction with bowel habits, and interference of IBS symptoms with daily life. Each item is scored from 0 to 100, resulting in a total score ranging from 0 to 500. Higher total scores indicate greater IBS symptom severity. Symptom severity is commonly categorized as: 75-174: Mild IBS 175-299: Moderate IBS ≥300: Severe IBS
Salivary Cortisol Level
时间窗: Baseline and at the end of the 6-week intervention period
Salivary cortisol levels are measured as a biomarker of physiological stress response. Saliva samples are collected using standardized procedures and analyzed using enzyme-linked immunosorbent assay methods. Cortisol concentrations are normalized to total protein concentration.
次要结局
- IBS-Related Quality of Life (Irritable Bowel Syndrome Quality of Life Questionnaire)(Baseline and at the end of the 6-week intervention period)
- Stool Form (Bristol Stool Form Scale)(Daily during the 6-week intervention period)
- Pain Catastrophizing (Pain Catastrophizing Scale)(Baseline and at the end of the 6-week intervention period)
- Pain Beliefs (Pain Beliefs Scale)(Baseline and at the end of the 6-week intervention period)
- Pain Knowledge (Revised Neurophysiology of Pain Questionnaire)(Baseline and at the end of the 6-week intervention period)
- Physical Activity Level (International Physical Activity Questionnaire - Short Form)(Baseline and at the end of the 6-week intervention period)