Pain Neuroscience Education for Chronic Pain (PNE)

July 6, 2026 updated by: Pilar Serra Añó, University of Valencia

Effectiveness of Pain Neuroscience Education Combined With Therapeutic Exercise in People With Chronic Pain

Chronic pain is an unpleasant sensory and emotional experience associated with actual or potential tissue damage, with a high prevalence in Spain (25.9%) and an average duration of 6.83 years, highlighting its significant health and social impact. Among its manifestations, chronic low back pain (CLBP) is the most common, affecting 58.1% of individuals with chronic pain, while fibromyalgia (FM) accounts for 10.4%. In both cases, a relevant proportion of patients do not present a clear organic cause, which complicates diagnosis and treatment and reflects the complexity of nonspecific chronic pain.

CLBP is associated with a high functional and occupational impact, being one of the main causes of temporary disability. FM, on the other hand, is characterized by widespread musculoskeletal pain accompanied by fatigue, sleep disturbances, and emotional symptoms, constituting a condition with systemic involvement. Both conditions can occur throughout the lifespan, with variations in prevalence depending on age, sex, social class, and the presence of comorbidities.

Aging introduces relevant differences in pain experience and treatment response. At the physiological level, changes occur in the musculoskeletal system, such as the progressive loss of muscle mass (especially type II fibers) and decreased bone mineral density, which increases the risk of sarcopenia and frailty. In contrast, young adults show greater anabolic capacity, better hypertrophic response, and higher neuromuscular efficiency, favoring faster adaptations to exercise. These differences justify the need to consider age as a key factor in the therapeutic approach.

In addition to structural changes, central sensitization plays a fundamental role in the chronification of pain. This process involves sustained hyperexcitability of the central nervous system, with a reduced pain threshold and altered inhibitory mechanisms, contributing to the persistence of pain even in the absence of significant tissue damage.

Therapeutic exercise (TE) is one of the main non-pharmacological interventions for chronic pain and has demonstrated effectiveness in reducing pain and improving functionality. However, its long-term effects are limited, largely due to adherence issues related to pain, as well as psychological, social, and educational factors. Educational level influences both the understanding of the intervention and adherence, generally being higher in young adults, which may affect treatment outcomes.

In this context, Pain Neuroscience Education (PNE) has emerged as a complementary strategy aimed at improving understanding of pain mechanisms and promoting adaptive behavioral changes. The combination of PNE and TE has shown positive effects in patients with CLBP and FM, especially in variables related to pain and psychosocial factors.

However, there is a lack of evidence regarding the impact of this combination on objective functional parameters, such as spinal movement during functional activities. Therefore, it is necessary to investigate the effectiveness of the combined intervention of PNE and TE not only on pain but also on biomechanical variables such as range, velocity, and quality of movement, using precise measurement instruments.

Study Overview

Status

Enrolling by invitation

Conditions

Intervention / Treatment

Detailed Description

This study aims to evaluate the effectiveness of Pain Neuroscience Education (PNE) combined with Therapeutic Exercise (TE) in individuals with chronic low back pain (CLBP) and fibromyalgia (FM). Chronic pain conditions are frequently associated with maladaptive pain beliefs, pain catastrophizing, central sensitization, and functional limitations. PNE has been proposed as an educational approach to improve patients' understanding of pain mechanisms and promote adaptive coping strategies, potentially enhancing the effects of exercise-based interventions.

The study is designed as a randomized controlled clinical trial including participants with either CLBP or FM. Participants will be stratified according to age (<65 years and ≥65 years) and clinical condition (CLBP or FM) and then randomly assigned to one of two intervention groups: (1) PNE combined with TE, or (2) placebo education combined with the same TE program.

The intervention period will last eight weeks. All participants will perform a standardized therapeutic exercise program focused on physical function and movement. Participants allocated to the experimental group will additionally receive PNE sessions addressing contemporary pain neuroscience concepts, including pain mechanisms, central sensitization, the influence of psychosocial factors, fear of movement, and self-management strategies. Participants in the control group will receive placebo educational sessions focused on anatomy and biomechanics, matched for duration and attention.

Assessments will be conducted at baseline, immediately after the intervention, and during follow-up periods at 4, 12, and 24 weeks after treatment completion. The study will examine changes in pain-related, psychological, sensory, and functional outcomes over time and compare responses between clinical conditions and age groups.

The results of this study may contribute to understanding the added value of PNE when combined with therapeutic exercise and whether age and clinical diagnosis influence treatment response in individuals with chronic pain.

Study Type

Interventional

Enrollment (Estimated)

84

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Spain
    • Valencia
      • Valencia, Valencia, Spain, 46010
        • Facultat de Fisioteràpia

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

Fibromyalgia (FM)

Inclusion Criteria:

  • Diagnosis of fibromyalgia according to the 2010/2011 American College of -Rheumatology criteria
  • Ability to understand and follow study instructions (Mini-Mental State Examination [MMSE] score >23)

Exclusion Criteria:

  • Changes in medication during the month prior to enrollment
  • Disorders affecting the central or peripheral nervous system

Chronic Low Back Pain (CLBP)

Inclusion Criteria:

  • Chronic low back pain lasting at least 3 months
  • Low back pain occurring on 3 or more days per week
  • Pain located between the lower rib margin and the gluteal folds
  • Ability to understand and follow study instructions (Mini-Mental State Examination [MMSE] score >23)

Exclusion Criteria:

  • Changes in medication during the month prior to enrollment
  • Disorders affecting the central or peripheral nervous system
  • History of spinal surgery

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Triple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: EG Fibromyalgia
Fibromyalgia Intervention Group: Exercise and Pain Education
Other: Therapeutic Exercise and Education in Pain Neuroscience
For the experimental group, the intervention consists of an 8-week therapeutic exercise program combined with education on the neuroscience of pain, comprising 3 exercise sessions and 1 educational session per week.
Placebo Comparator: CG Fibromyalgia
Fibromyalgia Control Group: Exercise and Placebo Education
Other: Therapeutic exercise and education in the neuroscience of pain: the placebo effect
For the control group, the intervention consists of a therapeutic exercise program combined with placebo education, which introduces basic concepts of anatomy and biomechanics. The intervention lasts 8 weeks, with 3 exercise sessions and 1 education session per week.
Experimental: EG Chronic Low Back Pain
Experimental Group for Chronic Low Back Pain: Exercise and Pain Education
Other: Therapeutic Exercise and Education in Pain Neuroscience
For the experimental group, the intervention consists of an 8-week therapeutic exercise program combined with education on the neuroscience of pain, comprising 3 exercise sessions and 1 educational session per week.
Placebo Comparator: CG Chronic Low Back Pain
Experimental Group for Chronic Low Back Pain: Exercise and Placebo Education
Other: Therapeutic exercise and education in the neuroscience of pain: the placebo effect
For the control group, the intervention consists of a therapeutic exercise program combined with placebo education, which introduces basic concepts of anatomy and biomechanics. The intervention lasts 8 weeks, with 3 exercise sessions and 1 education session per week.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Level of physical activity
Time Frame: Before the procedure, after the procedure, one month later, three months later, and six months later the procedure.
Using the International Physical Activity Questionnaire (IPAQ). Scores are expressed in MET-minutes/week. Higher scores indicate higher levels of physical activity and a better outcome.
Before the procedure, after the procedure, one month later, three months later, and six months later the procedure.
Central level of awareness
Time Frame: Before the procedure, after the procedure, one month later, three months later, and six months later the procedure.
Using the Central Sensitization Inventory (CSI). Total score ranges from 0 to 100. Higher scores indicate greater symptoms related to central sensitization and a worse outcome.
Before the procedure, after the procedure, one month later, three months later, and six months later the procedure.
Pain on movement
Time Frame: Before the procedure, after the procedure, one month later, three months later, and six months later the procedure.
Pain using the Visual Analogue Scale (VAS): Scores range from 0 to 10, with higher scores indicating greater pain intensity and a worse outcome.
Before the procedure, after the procedure, one month later, three months later, and six months later the procedure.
Level of catastrophizing
Time Frame: Before the procedure, after the procedure, one month later, three months later, and six months later the procedure.
Level of catastrophizing using the Pain Catastrophizing Scale (PCS). Total score ranges from 0 to 52. Higher scores indicate greater pain catastrophizing and a worse outcome.
Before the procedure, after the procedure, one month later, three months later, and six months later the procedure.
Functionality - Lumbar movements
Time Frame: Before the procedure, after the procedure, one month later, three months later, and six months later the procedure.
Using a motion capture system. Each movement is performed 5 times (the middle 3 repetitions will be analyzed). In all cases, pain will be assessed using a visual analog scale ranging from 0 to 10. Thirty-six markers will be placed throughout the body, except on the hands. The tests measured using the motion capture system will be: lumbar flexion-extension, rotations, and lateral bending.
Before the procedure, after the procedure, one month later, three months later, and six months later the procedure.
Functionality - The 5 Time Sit to Stand Test
Time Frame: Before the procedure, after the procedure, one month later, three months later, and six months later the procedure.
Using a motion capture system. Each movement is performed 5 times (the middle 3 repetitions will be analyzed). In all cases, pain will be assessed using a visual analog scale ranging from 0 to 10. Thirty-six markers will be placed throughout the body, except on the hands. The test measured using the motion capture system will be the 5-Time Sit-to-Stand Test. he outcome is the time required to complete five consecutive sit-to-stand repetitions, measured in seconds. Scores range from 0 seconds to no theoretical maximum. Higher scores indicate poorer lower-limb functional performance and a worse outcome.
Before the procedure, after the procedure, one month later, three months later, and six months later the procedure.
Functionality - Lifting a 5 kg ball off the floor
Time Frame: Before the procedure, after the procedure, one month later, three months later, and six months later the procedure.
Using a motion capture system. Each movement is performed 5 times (the middle 3 repetitions will be analyzed). In all cases, pain will be assessed using a visual analog scale ranging from 0 to 10. Thirty-six markers will be placed throughout the body, except on the hands. The test measured using the motion capture system will be lifting a 5 kg ball from the floor in a free-standing position, in a deadlift and in a squat.
Before the procedure, after the procedure, one month later, three months later, and six months later the procedure.
Degree of disability
Time Frame: Before the procedure, after the procedure, one month later, three months later, and six months later the procedure.
Using the Oswestry Disability Index (ODI): Scores range from 0 to 100%, with higher scores indicating greater disability and a worse outcome.
Before the procedure, after the procedure, one month later, three months later, and six months later the procedure.
Conditioned Sensitivity Test
Time Frame: Before the procedure, after the procedure, one month later, three months later, and six months later the procedure.
Test to assess the condition of the nervous system. The test stimulus is applied using an algometer, and the pressure pain threshold is assessed on the tibialis anterior muscle (5 cm distal to the tibial tuberosity). The patient verbally reports the point at which pressure becomes painful (the average of three consecutive measurements is calculated). Next, a conditioning stimulus is applied using a blood pressure cuff at a constant pressure of 240 mmHg for 120 seconds. Finally, the pressure pain threshold in the tibialis anterior is assessed.
Before the procedure, after the procedure, one month later, three months later, and six months later the procedure.
Biering-Sörensen Test
Time Frame: Before the procedure, after the procedure, one month later, three months later, and six months later the procedure.
This is a functional test of the lumbar spine used to measure the isometric strength and endurance of the trunk extensor muscles, particularly in the lumbar spine. This test is measured using surface electromyography (EMG), and the electrodes-which are 20 mm in size-should be placed on the iliocostalis muscle 3-4 cm lateral to the midline and at the level of L2-L4.
Before the procedure, after the procedure, one month later, three months later, and six months later the procedure.

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Anthropometric data - Weigth
Time Frame: Before the procedure, after the procedure, one month later, three months later, and six months later the procedure.
Weight will be measured using a bioimpedance scale and will be reported in kilograms.
Before the procedure, after the procedure, one month later, three months later, and six months later the procedure.
Demographic data - Age
Time Frame: Before the procedure, after the procedure, one month later, three months later, and six months later the procedure.
Age. Age will be expressed in years.
Before the procedure, after the procedure, one month later, three months later, and six months later the procedure.
Anthropometric data - Body Mass Index (BMI)
Time Frame: Before the procedure, after the procedure, one month later, three months later, and six months later the procedure.
Body Mass Index. BMI will be measured using a bioimpedance scale and will be expressed as a percentage and in kg/m²
Before the procedure, after the procedure, one month later, three months later, and six months later the procedure.
Demographic data - Gender
Time Frame: In the initial valuation.
Gender (male or female)
In the initial valuation.
Sensitivity
Time Frame: Before the procedure, after the procedure, one month later, three months later, and six months later the procedure.
Using the Semmes-Weinstein monofilament test for tactile sensitivity and the pinprick test for pain sensitivity by dermatome.
Before the procedure, after the procedure, one month later, three months later, and six months later the procedure.
Anxiety and depression
Time Frame: Before the procedure, after the procedure, one month later, three months later, and six months later the procedure.
Using the Hospital Anxiety and Depression Scale (HADS). Total score ranges from 0 to 42. Higher scores indicate greater anxiety and depression symptoms and a worse outcome.
Before the procedure, after the procedure, one month later, three months later, and six months later the procedure.
Kinesiophobia
Time Frame: Before the procedure, after the procedure, one month later, three months later, and six months later the procedure.
Using the Fear-Avoidance Beliefs Questionnaire (FABQ). Total score ranges from 0 to 96. Higher scores indicate stronger fear-avoidance beliefs and a worse outcome.
Before the procedure, after the procedure, one month later, three months later, and six months later the procedure.
Fibromyalgia Index
Time Frame: Before the procedure, after the procedure, one month later, three months later, and six months later the procedure.
Using the Fibromyalgia Impact Questionnaire (FIQ).Total score ranges from 0 to 100. Higher scores indicate greater impact of fibromyalgia and a worse outcome.
Before the procedure, after the procedure, one month later, three months later, and six months later the procedure.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Valencia

Investigators

  • Study Director: Sara Mollá, Casanova, Universitat de València

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

May 5, 2026

Primary Completion (Estimated)

December 31, 2026

Study Completion (Estimated)

December 31, 2028

Study Registration Dates

First Submitted

June 4, 2026

First Submitted That Met QC Criteria

July 6, 2026

First Posted (Actual)

July 9, 2026

Study Record Updates

Last Update Posted (Actual)

July 9, 2026

Last Update Submitted That Met QC Criteria

July 6, 2026

Last Verified

June 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2025-FIS-4161138

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

IPD Plan Description

For data protection purposes.

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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