Chronic Low Back PainPNE-MOVENCT07152171
Pain Neuroscience Education Delivered During Aerobic Exercise Versus Exercise Alone
A study testing Pain Neuroscience Education During Aerobic Exercise and Aerobic Exercise Alone in people with Chronic Low Back Pain, run by University of Chile at 1 site in Chile.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Chronic Low Back Pain
- What is being tested?
- Pain Neuroscience Education During Aerobic Exercise and Aerobic Exercise Alone
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 24 participants
- Where
- 1 siteChile
- Study dates
- 25 Aug 2025to 15 Jan 2026
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Pain Neuroscience Education Delivered During Aerobic Exercise Versus Exercise Alone in Chronic Low Back Pain
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:
Read more
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.
Read the 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 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.
- Conditions
- Chronic Low Back Pain
- Being tested
- Pain Neuroscience Education During Aerobic Exercise, Aerobic Exercise Alone
- Keywords
- Musculoskeletal Pain, Pain Neuroscience Education, Aerobic Exercise, Physical Therapy, Rehabilitation
- Medical subject headings
- Musculoskeletal Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Pain Neuroscience Education During Aerobic ExerciseBehavioural
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 AloneBehavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: Behavioral: Aerobic Exercise Alone |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Baseline (pre-session) and immediately post-intervention (within 30 minutes)
Secondary outcomes (3)
Change in Pressure Pain Threshold (kgf) by Algometry
Baseline (pre-session) and immediately post-intervention (within 30 minutes)
Measured: 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)
Baseline (pre-session) and immediately post-intervention (within 30 minutes)
Measured: 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)
Participants rate statements such as "I felt physically comfortable during the session" and "The environment felt safe to exercise" on 5-point Likert scales. Higher scores reflect greater perceived safety/comfort.
Measured: Immediately post-intervention (within 30 minutes)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Sep 2025
- Study start25 Aug 2025
- Primary completion15 Jan 2026
- Study completion15 Jan 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Chronic Low Back PainStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- 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.
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 24 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Chile
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, RODRIGO NUNEZ, University of Chile
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07152171
- Sponsor's protocol ID
- 0469
- Acronym
- PNE-MOVE
- Status last verified
- Feb 2026
- First submitted
- 21 Aug 2025
- Last updated
- 27 Feb 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 27 Feb 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Pain Neuroscience Education Delivered During Aerobic Exercise Versus Exercise Alone in Chronic Low Back Pain
- ClinicalTrials.gov ID
- NCT07152171
- Acronym / sponsor ID
- PNE-MOVE / 0469
- Conditions
- Chronic Low Back Pain
- Keywords
- Musculoskeletal Pain, Pain Neuroscience Education, Aerobic Exercise, Physical Therapy, Rehabilitation
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 24 participants (actual)
- Lead sponsor
- University of ChileUniversity, hospital or other
- Study start
- 25 Aug 2025 (actual)
- Primary completion
- 15 Jan 2026 (actual)
- Study completion
- 15 Jan 2026 (actual)
- First posted
- 3 Sep 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
- Model description
- 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.
| Arm | Type | Receives |
|---|---|---|
| Pain Neuroscience Education During Aerobic Exercise | Experimental | Behavioral: Pain Neuroscience Education During Aerobic ExerciseParticipants 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. |
| Aerobic Exercise Alone | Active comparator | Behavioral: Aerobic Exercise AloneParticipants 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. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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.
Key exclusion criteria (7 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Pain Neuroscience Education During Aerobic ExerciseParticipants 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. | Behavioural | Pain Neuroscience Education During Aerobic Exercise |
| Aerobic Exercise AloneParticipants 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. | Behavioural | Aerobic Exercise Alone |
Primary outcome
Change in Pain Intensity (Visual Analog Scale, 0-10)
Time frame: 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.
3 secondary outcomes
Change in Pressure Pain Threshold (kgf) by Algometry
Time frame: 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)
Time frame: 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)
Time frame: Immediately post-intervention (within 30 minutes)
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Feb 2026.
- Individual participant dataSharing planned: No
Related trials for Chronic Low Back Pain
Not yet recruiting
Effect of Lumbar Stabilization Exercises With and Without YTWL (Scapular Stabilization Exercises) on Reducing Chronic Low Back Pain and Related Disability. A Randomized Clinical Trial,
Chronic Non Specific Mechanical Low Back Pain
Not yet recruiting
Comparing Non-Medicine Strategies for Improving Low Back Pain
Chronic Low-back Pain (cLBP), High-Impact Chronic Pain (HICP)
Not yet recruiting
Spinery Basivertebral Nerve Ablation for Vertebrogenic Chronic Low Back Pain
Low Back Pain, Chronic Low Back Pain (CLBP)
Enrolling by invitation
Effects of 3-dimensional Versus Dynamic Myofascial Release Techniques With Lumbar Mobilization and Exercise Therapy Program in Chronic Non-specific Low Back Pain.
Chronic Non-Specific Low Back Pain, Myofascial Release
RecruitingPhase 2
A Master Protocol Study (LY900028) of Multiple Intervention-Specific-Appendices (ISAs) in Participants With Chronic Pain
Osteoarthritis, Knee, Diabetic Neuropathic Pain
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Pain Neuroscience Education During Aerobic Exercise and Aerobic Exercise Alone in people with Chronic Low Back Pain, run by University of Chile at 1 site in Chile.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 27 Feb 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Chile. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in Pain Intensity (Visual Analog Scale, 0-10) (time frame: Baseline (pre-session) and immediately post-intervention (within 30 minutes)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 27 Feb 2026.