Pain Neuroscience Education for Chronic Pain

Official title

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

Overview

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.

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.

Interventions

• 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.
• 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.

Primary outcome measures

• Level of physical activity [Time frame: 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.]
• Pain on movement [Time frame: 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.]
• Functionality - Lumbar movements [Time frame: 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.]
• 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.]
• Degree of disability [Time frame: 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.]
• Biering-Sörensen Test [Time frame: Before the procedure, after the procedure, one month later, three months later, and six months later the procedure.]

Secondary outcome measures (8)

• Anthropometric data - Weigth [Time frame: 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.]
• 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.]
• Demographic data - Gender [Time frame: 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.]
• Anxiety and depression [Time frame: 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.]
• Fibromyalgia Index [Time frame: Before the procedure, after the procedure, one month later, three months later, and six months later the procedure.]

Eligibility criteria

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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation

Randomized

Model

Parallel assignment

Masking

Triple blind

Primary purpose

Treatment

Study locations

Spain · 1 center

• Facultat de Fisioteràpia — Valencia

Identifiers

NCT: NCT07693998 · 2025-FIS-4161138

Primary sources (government registries)

• ClinicalTrials.gov (US NIH)

View this study on ClinicalTrials.gov ↗