Pain Science Education and Graded Exposure for Chronic Low Back Pain

ConditionChronic Low-back Pain (cLBP)

Trial statusNot yet recruiting

Trial phaseNot applicable

Trial typeInterventional

Biological sexAll

Age18-60

SponsorUniversity of Chile

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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.

Disqualifiers

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.

Trial design

Design model

Parallel

Treatments tested in this trial

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.
Usual Physical Therapy
Other intervention
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.

Treatment groups

82 Participants

are divided into 2 treatment groups

Group A: Pain Science Education Plus Graded ExposureExperimental treatment 1 intervention

Group B: Usual Physical TherapyActive comparator 1 intervention

Trial outcomes

Primary outcomes

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