Pain Neuroscience Education Delivered During Aerobic Exercise Versus Exercise Alone in Chronic Low Back Pain
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 28
- 试验地点
- 1
- 主要终点
- Change in Pain Intensity (Visual Analog Scale, 0-10)
研究概览
简要总结
Chronic musculoskeletal pain is a common health condition that reduces quality of life and increases disability. Pain neuroscience education (PNE) has shown positive effects on pain perception, beliefs, and function, especially when combined with physical activity. This randomized controlled trial will compare the effectiveness of delivering PNE during aerobic exercise on a cycle ergometer versus aerobic exercise alone in patients with chronic musculoskeletal pain.
Participants will be randomly assigned to one of two groups:
PNE during aerobic exercise (experimental group),
Aerobic exercise alone (control group).
Both groups will perform supervised cycling sessions lasting 20-30 minutes at light intensity (Borg CR10 = 3, 40-50% HRmax). The experimental group will simultaneously receive interactive education about pain mechanisms, central sensitization, and self-management strategies, supported by visual aids and metaphors delivered by a therapist during cycling.
Outcomes will be measured at baseline and after the intervention, including:
Pain intensity (Visual Analog Scale),
Pressure pain threshold (algometry),
Functional performance (Sit-to-Stand test),
Perceived effort (Borg CR10),
Safety and comfort (Likert scale),
Muscle activity (surface EMG).
The study will enroll 28 participants (14 per group). The findings are expected to clarify whether integrating education with exercise provides superior benefits compared to exercise alone, offering an innovative, safe, and cost-effective strategy for managing chronic musculoskeletal pain.
详细描述
Objective To determine whether PNE delivered during cycling exercise produces greater improvements in pain intensity, pain thresholds, and functional outcomes than aerobic exercise alone.
Study Design This is a single-center, randomized controlled trial with two parallel arms (1:1 allocation). A total of 28 participants with chronic musculoskeletal pain will be recruited from the Hospital Clínico de la Universidad de Chile. Randomization will assign 14 participants to the experimental group and 14 to the control group, using the Randomization software (www.randomization.com). The random sequence will be determined prior to the start of the initial assessments and will only be known to an external research assistant with no access to participant characteristics. The assignment will remain hidden and stored in the cloud until the end of the intervention and the collection of all study data. When a participant enrolls in the study, the external research assistant will inform the therapist of the assigned intervention group.
Intervention Experimental group (PNE + exercise): 20-30 minutes of supervised cycling at light intensity (Perceived exertion, Borg CR10 = 3) while receiving interactive PNE. Education covers neurobiology of pain, central sensitization, and self-management, supported by visual aids and metaphors.
Control group (exercise alone): 20-30 minutes of supervised cycling at the same intensity (Perceived exertion, Borg CR10 = 3), without educational content.
Sample Size and Analysis Based on prior effect sizes, 28 participants (14 per group) provide sufficient power to detect moderate differences. Data will be analyzed with mixed-model ANOVA (time × group) and additional parametric or nonparametric tests as appropriate. Statistical significance is set at p < 0.05.
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
- Single (Outcomes Assessor)
盲法说明
Outcome assessors will be blinded to group allocation. Participants and care providers cannot be blinded due to the nature of the intervention.
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 18 to 65 years.
- •Diagnosis of chronic low back pain lasting ≥ 12 weeks.
- •Baseline pain intensity ≥ 4/10 on the Visual Analog Scale (VAS).
- •Able to perform light to moderate aerobic exercise
- •Willing and able to provide informed consent.
排除标准
- •Inability to understand or follow instructions.
- •Pregnancy.
- •Active cancer diagnosis.
- •Neurological disorders affecting the central nervous system (e.g., stroke).
- •Participation in alternative or concurrent therapies for pain management.
- •History of major orthopedic trauma or surgery in the last 12 months.
- •Any medical contraindication to light exercise identified during the medical screening.
结局指标
主要结局
Change in Pain Intensity (Visual Analog Scale, 0-10)
时间窗: Baseline (pre-session) and immediately post-intervention (within 30 minutes)
Pain intensity will be assessed using a 10-cm Visual Analog Scale (VAS; 0 = no pain, 10 = worst imaginable pain). The primary endpoint is the change score (post-session minus baseline). Higher scores indicate greater pain.
次要结局
- Change in Pressure Pain Threshold (kgf) by Algometry(Pressure pain threshold (PPT) will be measured at the most symptomatic lumbar region using a handheld algometer. Pressure is increased at a constant rate until the participant first perceives pain; the value (kgf) is recorded. The outcome is the change s)
- Change in Functional Performance (30-Second Sit-to-Stand Test)(Participants sit on a standard chair (≈43 cm height) with arms crossed and stand up/sit down as many times as possible in 30 seconds. The total number of full stands is recorded. The outcome is the change in repetitions from baseline.)
- Safety and Comfort Ratings (Likert Scales)(Immediately post-intervention (within 30 minutes))
研究者
RODRIGO NUNEZ
Assistant Professor, PhD
University of Chile