Pain Science Education and Graded Exposure for Chronic Low Back Pain

NCT07836946 | Not Yet Recruiting

• 2 other identifiers: FONDECYT-1126136211261362
• Study Type: interventional
• Target: 82
• Locations: 0 countries
• Sites: N/A

Brief 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. 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.

Conditions

Chronic Low-back Pain (cLBP)

Outcome Measures

Primary Outcomes (2)

• 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.

  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.

  Baseline and immediately after the 6-week intervention

Secondary Outcomes (7)

• Heart Rate Variability

  Baseline and immediately after the 6-week intervention

• Skin Conductance

  Baseline and immediately after the 6-week intervention

• Trunk Muscle Co-contraction During the Lifting Task

  Baseline and immediately after the 6-week intervention

• Kinesiophobia

  Baseline and immediately after the 6-week intervention

• Task-Specific Fear

  Baseline and immediately after the 6-week intervention

Study Arms (2)

Pain Science Education Plus Graded Exposure

EXPERIMENTAL

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

Usual Physical Therapy

ACTIVE COMPARATOR

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

Interventions

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.

Also known as: Pain Neuroscience Education Plus Graded Exposure

Pain Science 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.

Usual Physical Therapy

Eligibility Criteria

• Age: 18 Years - 60 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• University of Chile: lead
• Agencia Nacional de Investigación y Desarrollo: collaborator

Central Study Contacts

Rodrigo Núñez-Cortés, PhD

CONTACT

928777254; r_nunez@uchile.cl

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: September 17, 2026
• First Posted: September 23, 2026
• Study Start (Estimated): November 2, 2026
• Primary Completion (Estimated): March 31, 2028
• Study Completion (Estimated): March 31, 2028
• Last Updated: September 23, 2026

Record last verified: 2026-09

Data Sharing

• IPD Sharing: Will share