Pain Neuroscience Education for Chronic Pain

NCT07693998 | Enrolling By Invitation

• 1 other identifier: 2025-FIS-4161138
• Study Type: interventional
• Target: 84
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Chronic Low Back Pain (CLBP); Fibromyalgia (FM); Chronic Pain

Keywords

chronic low back pain; therapeutic exercise; pain neuroscience education; fibromyalgia; chronic pain

Outcome Measures

Primary Outcomes (10)

• Level of physical activity

  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

  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

  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

  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

  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

  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

  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

  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

  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

  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 Outcomes (8)

• Anthropometric data - Weigth

  Before the procedure, after the procedure, one month later, three months later, and six months later the procedure.

• Demographic data - Age

  Before the procedure, after the procedure, one month later, three months later, and six months later the procedure.

• Anthropometric data - Body Mass Index (BMI)

  Before the procedure, after the procedure, one month later, three months later, and six months later the procedure.

• Demographic data - Gender

  In the initial valuation.

• Sensitivity

  Before the procedure, after the procedure, one month later, three months later, and six months later the procedure.

Study Arms (4)

EG Fibromyalgia

EXPERIMENTAL

Fibromyalgia Intervention Group: Exercise and Pain Education

Other: Therapeutic Exercise and Education in Pain Neuroscience

CG Fibromyalgia

PLACEBO COMPARATOR

Fibromyalgia Control Group: Exercise and Placebo Education

Other: Therapeutic exercise and education in the neuroscience of pain: the placebo effect

EG Chronic Low Back Pain

EXPERIMENTAL

Experimental Group for Chronic Low Back Pain: Exercise and Pain Education

Other: Therapeutic Exercise and Education in Pain Neuroscience

CG Chronic Low Back Pain

PLACEBO COMPARATOR

Experimental Group for Chronic Low Back Pain: Exercise and Placebo Education

Other: Therapeutic exercise and education in the neuroscience of pain: the placebo effect

Interventions

Therapeutic Exercise and Education in Pain Neuroscience OTHER

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.

EG Chronic Low Back Pain; EG Fibromyalgia

Therapeutic exercise and education in the neuroscience of pain: the placebo effect OTHER

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.

CG Chronic Low Back Pain; CG Fibromyalgia

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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)

You may not qualify if:

• Changes in medication during the month prior to enrollment
• Disorders affecting the central or peripheral nervous system
• Chronic Low Back Pain (CLBP)
• 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)
• Changes in medication during the month prior to enrollment
• Disorders affecting the central or peripheral nervous system
• History of spinal surgery

Sponsors & Collaborators

• University of Valencia: lead

Study Sites (1)

Facultat de Fisioteràpia

Valencia, Valencia, 46010, Spain

Location

MeSH Terms

Conditions

Fibromyalgia; Chronic Pain

Interventions

Exercise Therapy; Educational Status

Condition Hierarchy (Ancestors)

Muscular Diseases; Musculoskeletal Diseases; Rheumatic Diseases; Neuromuscular Diseases; Nervous System Diseases; Pain; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Rehabilitation; Aftercare; Continuity of Patient Care; Patient Care; Therapeutics; Physical Therapy Modalities; Socioeconomic Factors; Population Characteristics

Study Officials

• Sara Mollá, Casanova

  Universitat de València

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Full Professor

Model Details: The study design is a clinical intervention trial. The study will be divided into two substudies conducted in parallel, based on the participants' condition-chronic low back pain (CLBP) or fibromyalgia (FM)-and their age (under 65 years and over 65 years).

Study Record Dates

• First Submitted: June 4, 2026
• First Posted: July 9, 2026
• Study Start: May 5, 2026
• Primary Completion (Estimated): December 31, 2026
• Study Completion (Estimated): December 31, 2028
• Last Updated: July 9, 2026

Record last verified: 2026-06

Data Sharing

• IPD Sharing: Will not share

Locations

ES (1)