Pain Neuroscience Education Delivered During Aerobic Exercise Versus Exercise Alone

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 24 participants with chronic low back pain will be recruited from the Hospital Clínico de la Universidad de Chile. Randomization will assign 12 participants to the experimental group and 12 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.

Ethical Considerations The study is approved by the Ethics Committee of Hospital Clínico de la Universidad de Chile. Participants will provide informed consent before participation. Risks are minimal (fatigue or mild discomfort), while expected benefits include improved pain understanding, reduced pain intensity, and improved function. This study will be conducted in accordance with the Declaration of Helsinki.

Inclusion criteria

• 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.

Exclusion criteria

• 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.