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Chronic Low-back Pain (cLBP)PSE-GEMNCT07836946

Pain Science Education and Graded Exposure for Chronic Low Back Pain

A study testing Pain Science Education Plus Graded Exposure and Usual Physical Therapy in people with Chronic Low-back Pain (cLBP), run by University of Chile.

Not yet recruiting

Opening soon. The study is approved but enrolment has not started yet. Sites may already take enquiries.

Sites and contacts
Official record
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Trial summary

Chronic low back pain can affect daily activities and may be influenced by how people understand pain, their fear of movement, and their responses to stressful or uncertain physical activities. Read more about this study

Who is it for?
Ages 18 to 60 years
Conditions the study is for
Chronic Low-back Pain (cLBP)
What is being tested?
Pain Science Education Plus Graded Exposure and Usual Physical Therapy
Could I receive a placebo?
No, everyone receives an active treatment
How many people
82 participants
Where
No sites listed yet
Study dates
2 Nov 2026to 31 Mar 2028
Phase
Interventional
Are there results?
Not yet: the study is under way

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 60 years
  • All sexes
  • No healthy volunteers
  • Adult

Who may be able to join

  • Men and women aged 18 to 60 years.
  • Diagnosis of chronic low back pain, defined as low back pain occurring every day for at least 3 months or on at least half of the days during the previous 6 -months.
  • Willingness to participate in the study.

Who cannot join

  • Body mass index >30 kg/m².
  • Inability to understand study instructions.
  • Neurological conditions affecting the central nervous system (e.g., stroke or spinal cord injury).
  • Pregnancy.
  • Currently receiving alternative therapies.
  • Previous participation in a pain education program.
  • History of trauma or orthopedic surgery within the previous 12 months.

Trial locations and contacts

No sites are listed yet. Contact the study team or a site near you to ask about taking part.

Rodrigo Núñez-Cortés, PhD contact

928777254

r_nunez@uchile.cl

About this study

Official title: Effect of Pain Science Education Combined With Graded Exposure to Movement on Physiological Stress Responses and Motor Performance in Patients With Chronic Low Back Pain

Chronic low back pain can affect daily activities and may be influenced by how people understand pain, their fear of movement, and their responses to stressful or uncertain physical activities. This clinical trial will evaluate whether a 6-week program combining pain science education with graded exposure to movement is more effective than usual physical therapy for adults with chronic low back pain.

Participants will be randomly assigned to one of two groups: pain science education combined with graded exposure to movement, or usual physical therapy. The study will assess changes in pain, disability, fear of movement, and pain-related thoughts. It will also examine physiological responses to stress and muscle activity while participants perform a lifting task.

The study aims to determine whether combining education about pain with gradual exposure to feared movements can improve clinical outcomes, physiological responses to stress, and motor performance in people with chronic low back pain.

Being tested
Pain Science Education Plus Graded Exposure, Usual Physical Therapy

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Pain Science Education Plus Graded ExposureBehavioural

    Also called Pain Neuroscience Education Plus Graded Exposure

    Participants will receive six 30-minute pain science education sessions over 6 weeks, including two group sessions, two individual online sessions, and two asynchronous sessions. Education will address pain neurobiology, the relationship between pain and tissue damage, pain modulation, cognitive and emotional influences on pain, neuroplasticity, self-management, and the role of movement. Participants will also receive six weekly individual, in-person graded exposure sessions. Feared or avoided functional activities will be identified and hierarchically ordered, and participants will be gradually exposed to these activities. Progression will be individualized by modifying load, speed, or range of motion.

  • Usual Physical TherapyOther

    Participants will receive one 30-minute group educational session addressing mechanical causes of low back pain, spinal anatomy, physiology and biomechanics, self-care and ergonomics, lifting techniques, and therapeutic exercise. Participants will also receive one in-person physical therapy session per week for 6 weeks, including stretching, thermotherapy, electrotherapy, and conventional core stabilization exercises (3-4 sets of 20-30 repetitions). Participants will be instructed to perform trunk stabilization exercises at home three days per week.

Study groups in NCT07836946
Study groupRoleWhat they receive
Pain Science Education Plus Graded ExposureExperimentalParticipants will receive a 6-week program combining pain science education with graded exposure to movement. Pain science education will be delivered once weekly through a hybrid format, including group, individual online, and asynchronous sessions. Participants will also receive one individual, in-person graded exposure session per week for 6 weeks. Graded exposure will be individualized according to activities that participants fear or avoid, with progressive modification of load, speed, or range of motion.
Receives: Behavioral: Pain Science Education Plus Graded Exposure
Usual Physical TherapyActive comparatorParticipants will receive usual physical therapy for 6 weeks. The intervention will include one group-based educational session on low back pain and one in-person physical therapy session per week for 6 weeks. Physical therapy will include stretching, thermotherapy, electrotherapy, and conventional core stabilization exercises. Participants will also be instructed to perform trunk stabilization exercises at home three days per week.
Receives: Other: Usual Physical Therapy

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Pain Intensity

    Pain intensity will be assessed using a 100-mm Visual Analog Scale (VAS), ranging from 0 mm ("no pain") to 100 mm ("worst pain imaginable"). Higher scores indicate greater pain intensity.

    Measured: Baseline and immediately after the 6-week intervention

  2. Low Back Pain-Related Disability

    Disability will be assessed using the validated Spanish version of the Roland-Morris Disability Questionnaire (RMDQ). The questionnaire consists of 24 items scored as 0 or 1, resulting in a total score ranging from 0 to 24. Higher scores indicate greater low back pain-related disability.

    Measured: Baseline and immediately after the 6-week intervention

Secondary outcomes (7)

  1. Heart Rate Variability

    Heart rate variability (HRV) will be assessed using time- and frequency-domain measures, including high-frequency (HF) power, low-frequency (LF) power, and the root mean square of successive differences (RMSSD). HRV will be assessed at rest and during anticipation of the lifting task.

    Measured: Baseline and immediately after the 6-week intervention

  2. Skin Conductance

    Skin conductance will be assessed using the MED-STORM PAIN MONITOR. The number of fluctuations in skin conductance per second (NFSC) will be recorded using electrodes placed on the palms of the hands. Skin conductance will be assessed at rest and during anticipation of the lifting task, with higher NFSC values indicating greater sympathetic reactivity.

    Measured: Baseline and immediately after the 6-week intervention

  3. Trunk Muscle Co-contraction During the Lifting Task

    Surface electromyography (sEMG) will be recorded from the external oblique, rectus abdominis, erector spinae, and multifidus during the lifting task. Muscle co-contraction will be calculated from the area of overlap between paired muscle activation profiles, resulting in values ranging from 0 to 1, where 1 represents complete overlap.

    Measured: Baseline and immediately after the 6-week intervention

  4. Kinesiophobia

    Kinesiophobia will be assessed using the Spanish version of the 11-item Tampa Scale for Kinesiophobia (TSK-11). Total scores range from 11 to 44, with higher scores indicating greater kinesiophobia.

    Measured: Baseline and immediately after the 6-week intervention

  5. Task-Specific Fear

    Fear related specifically to the lifting task will be assessed using an 11-point Numerical Rating Scale ranging from 0 to 10, with higher scores indicating greater task-specific fear.

    Measured: Baseline and immediately after the 6-week intervention

  6. Pain Catastrophizing

    Pain catastrophizing will be assessed using the 13-item Pain Catastrophizing Scale (PCS). Each item is scored from 0 to 4, resulting in a total score ranging from 0 to 52. Higher scores indicate greater pain catastrophizing

    Measured: Baseline and immediately after the 6-week intervention

  7. Intolerance of Uncertainty

    Intolerance of uncertainty will be assessed using the 27-item Intolerance of Uncertainty Scale. Each item is rated on a 5-point scale from 1 ("not at all characteristic of me") to 5 ("entirely characteristic of me"), with higher scores indicating greater intolerance of uncertainty.

    Measured: Baseline and immediately after the 6-week intervention

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted23 Sep 2026
  2. Study start2 Nov 2026 (estimated)
  3. Primary completion31 Mar 2028 (estimated)
  4. Study completion31 Mar 2028 (estimated)

Resources

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
Masking
Single blind
Who is masked
Outcomes assessor
Enrolment
82 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT07836946
Sponsor's protocol ID
FONDECYT-11261362
Other IDs
11261362
Acronym
PSE-GEM
Status last verified
Sep 2026
First submitted
17 Sep 2026
Last updated
23 Sep 2026
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
Yes: Deidentified individual participant data underlying the results reported in the primary publication may be made available to qualified researchers upon reasonable request to the corresponding author.

Questions about this trial

What is this clinical trial studying?

A study testing Pain Science Education Plus Graded Exposure and Usual Physical Therapy in people with Chronic Low-back Pain (cLBP), run by University of 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 3 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: opening soon, as of the sponsor's last update on 23 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.

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?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

Contact Rodrigo Núñez-Cortés, PhD (928777254, r_nunez@uchile.cl), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Pain Intensity (time frame: Baseline and immediately after the 6-week intervention). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT07836946.

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 23 Sep 2026.

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