Pain Neuroscience Education Delivered During Aerobic Exercise Versus Exercise Alone

NCT ID: NCT07152171

Last Updated: 2025-09-03

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: NA
• Total Enrollment: 28 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2025-08-25
• Study Completion Date: 2025-12-20

Brief Summary

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.

Detailed Description

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.

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.

Conditions

Chronic Low Back Pain

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

Pain Neuroscience Education During Aerobic Exercise

Participants will perform 20-30 minutes of supervised aerobic exercise on a cycle ergometer at light intensity (Borg CR10 = 3; 40-50% HRmax). During cycling, they will receive interactive pain neuroscience education covering neurobiology of pain, central sensitization, and self-management strategies. Education will be delivered by a therapist using metaphors and visual aids to facilitate understanding while exercising.

Group Type: EXPERIMENTAL

Pain Neuroscience Education During Aerobic Exercise

Intervention Type: BEHAVIORAL

Participants will cycle on an ergometer for 20-30 minutes at light intensity (Borg CR10 = 3; 40-50% HRmax). During cycling, they will receive interactive pain neuroscience education delivered by a therapist, including neurobiology of pain, central sensitization, and self-management strategies. Visual aids and metaphors will be used to facilitate understanding.

Aerobic Exercise Alone

Participants will perform 20-30 minutes of supervised aerobic exercise on a cycle ergometer at light intensity (Borg CR10 = 3; 40-50% HRmax). No educational content will be provided. Sessions include warm-up, main cycling phase, and cool-down. Exercise parameters (cadence, resistance, and effort perception) will be matched to the experimental group.

Group Type: ACTIVE_COMPARATOR

Aerobic Exercise Alone

Intervention Type: BEHAVIORAL

Participants will perform 20-30 minutes of supervised cycling on an ergometer at light intensity (Borg CR10 = 3; 40-50% HRmax). No educational content will be provided. Sessions will include warm-up, main phase, and cool-down, matched in duration and intensity to the experimental group.

Interventions

Pain Neuroscience Education During Aerobic Exercise

Participants will cycle on an ergometer for 20-30 minutes at light intensity (Borg CR10 = 3; 40-50% HRmax). During cycling, they will receive interactive pain neuroscience education delivered by a therapist, including neurobiology of pain, central sensitization, and self-management strategies. Visual aids and metaphors will be used to facilitate understanding.

Intervention Type: BEHAVIORAL

Aerobic Exercise Alone

Participants will perform 20-30 minutes of supervised cycling on an ergometer at light intensity (Borg CR10 = 3; 40-50% HRmax). No educational content will be provided. Sessions will include warm-up, main phase, and cool-down, matched in duration and intensity to the experimental group.

Intervention Type: BEHAVIORAL

Eligibility Criteria

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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 65 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

University of Chile

OTHER

Sponsor Role: lead

Responsible Party

RODRIGO NUNEZ

Assistant Professor, PhD

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

Hospital Clínico Universidad de Chile

Santiago, , Chile

Site Status: RECRUITING

Countries

Chile

Central Contacts

Rodrigo Núñez-Cortés, PhD

Role: CONTACT

r_nunez@uchile.cl

928777254

Facility Contacts

Christian Caballero-Sepulveda, BSc

Role: primary

christian.caballero.sepulveda@gmail.com

2978 8037

Other Identifiers

0469

Identifier Type: -

Identifier Source: org_study_id