Pain Neuroscience Education Delivered During Aerobic Exercise Versus Exercise Alone

NCT07152171 | Completed DMC

• 1 other identifier: 0469
• Study Type: interventional
• Target: 24
• Locations: 1 country
• Sites: 1

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), Safety and comfort (Likert scale), The study will enroll 24 participants (12 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.

Conditions

Chronic Low Back Pain

Keywords

Musculoskeletal Pain; Pain Neuroscience Education; Aerobic Exercise; Physical Therapy; Rehabilitation

Outcome Measures

Primary Outcomes (1)

• Change in Pain Intensity (Visual Analog Scale, 0-10)

  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.

  Baseline (pre-session) and immediately post-intervention (within 30 minutes)

Secondary Outcomes (3)

• 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)

Study Arms (2)

Pain Neuroscience Education During Aerobic Exercise

EXPERIMENTAL

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.

Behavioral: Pain Neuroscience Education During Aerobic Exercise

Aerobic Exercise Alone

ACTIVE COMPARATOR

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.

Behavioral: Aerobic Exercise Alone

Interventions

Pain Neuroscience Education During Aerobic Exercise 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.

Pain Neuroscience Education During Aerobic Exercise

Aerobic Exercise Alone 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.

Aerobic Exercise Alone

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• University of Chile: lead

Study Sites (1)

Hospital Clínico Universidad de Chile

Santiago, Chile

Location

MeSH Terms

Conditions

Musculoskeletal Pain

Interventions

Exercise

Condition Hierarchy (Ancestors)

Muscular Diseases; Musculoskeletal Diseases; Pain; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Motor Activity; Movement; Musculoskeletal Physiological Phenomena; Musculoskeletal and Neural Physiological Phenomena

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Masking Details: Outcome assessors will be blinded to group allocation. Participants and care providers cannot be blinded due to the nature of the intervention.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor, PhD

Model Details: This is a two-arm, single-center randomized controlled trial with parallel assignment. Participants with chronic low back pain will be randomized (1:1) to receive either pain neuroscience education delivered during aerobic cycling exercise or aerobic exercise alone. Outcome assessors will be blinded to group allocation.

Study Record Dates

• First Submitted: August 21, 2025
• First Posted: September 3, 2025
• Study Start: August 25, 2025
• Primary Completion: January 15, 2026
• Study Completion: January 15, 2026
• Last Updated: February 27, 2026

Record last verified: 2026-02

Data Sharing

• IPD Sharing: Will not share

Locations

CL (1)