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NCT Number: NCT07836946

Pain Science Education and Graded Exposure for 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.

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Key information

Conditions

Chronic Low-back Pain (cLBP)

Age range

18 year–60 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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.

Exclusion criteria

  • 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.

Treatment and study plan

Pain Science Education Plus Graded Exposure

Behavioral

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.

Other names: Pain Neuroscience Education Plus Graded Exposure

Usual Physical Therapy

Other

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.

Primary outcomes

  1. Pain Intensity

    Time frame: Baseline and immediately after the 6-week intervention

    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.

  2. Low Back Pain-Related Disability

    Time frame: Baseline and immediately after the 6-week intervention

    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.

Secondary outcomes

  1. Heart Rate Variability

    Time frame: Baseline and immediately after the 6-week intervention

    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.

  2. Skin Conductance

    Time frame: Baseline and immediately after the 6-week intervention

    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.

  3. Trunk Muscle Co-contraction During the Lifting Task

    Time frame: Baseline and immediately after the 6-week intervention

    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.

  4. Kinesiophobia

    Time frame: Baseline and immediately after the 6-week intervention

    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.

  5. Task-Specific Fear

    Time frame: Baseline and immediately after the 6-week intervention

    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.

  6. Pain Catastrophizing

    Time frame: Baseline and immediately after the 6-week intervention

    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

  7. Intolerance of Uncertainty

    Time frame: Baseline and immediately after the 6-week intervention

    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.

Interested in participating?

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Sponsors and collaborators

Lead sponsor

University of Chile

Other

Collaborators

  • Agencia Nacional de Investigación y Desarrollo

Registry information

Official study 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

Acronym: PSE-GEM

Important dates

Study start
2026
Primary completion
2028
Study completion
2028
First posted
Sep 23, 2026
Registry last updated
Sep 23, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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