An interventional study of Pain Science Education Plus Graded Exposure and Usual Physical Therapy in Chronic Low-back Pain (cLBP), sponsored by University of Chile. Not yet recruiting. Open to participants aged 18 Years to 60 Years. Per ClinicalTrials.gov, last updated 2026-09-23.
Sponsored by University of Chile · Not applicable, Interventional, and Treatment
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.
2,922 studies on the registry are indexed under Low Back Pain; 580 are open to participants now.
This study's planned enrollment of 82 is above the median of 60 across 2,364 interventional studies indexed under Low Back Pain.
Browse Low Back Pain studies →University of Chile is the lead sponsor of 194 studies on the registry; 38 are open to participants now.
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Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Weight in kilograms divided by height in metres squared. Example: 70 kg and 1.75 m gives 70 ÷ (1.75 × 1.75) ≈ 22.9.
What counts as overweight or obesity differs between countries (some use lower cut-offs), so go by the range the study states.
BMI (body mass index)
Weight in kilograms divided by height in metres squared. Example: 70 kg and 1.75 m gives 70 ÷ (1.75 × 1.75) ≈ 22.9.
What counts as overweight or obesity differs between countries (some use lower cut-offs), so go by the range the study states.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Participants 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.
Behavioral: Pain Science Education Plus Graded Exposure
Participants 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.
Other: Usual Physical Therapy
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.
Also known as: Pain Neuroscience Education Plus Graded Exposure
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.
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.
Time frame: Baseline and immediately after the 6-week intervention
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.
Time frame: Baseline and immediately after the 6-week intervention
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.
Time frame: Baseline and immediately after the 6-week intervention
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.
Time frame: Baseline and immediately after the 6-week intervention
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.
Time frame: Baseline and immediately after the 6-week intervention
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.
Time frame: Baseline and immediately after the 6-week intervention
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.
Time frame: Baseline and immediately after the 6-week intervention
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
Time frame: Baseline and immediately after the 6-week intervention
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.
Time frame: Baseline and immediately after the 6-week intervention
No study locations are listed for this record.
Plan to share: 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.
No publications or documents are linked to this record.
This study is not yet recruiting, as verified in Sep 2026. You cannot join it, but the record below documents what was studied.
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