Pain Neuroscience Education for Chronic Pain

Sponsor
University of Valencia
Study ID
NCT07693998
Status
Enrolling By Invitation

Conditions

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

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

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.
  • 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.

Study Details

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.

Key Dates

First listed
Jul 9, 2026
Start date
May 5, 2026
Status verified
Jun 2026
Primary completion
Dec 31, 2026
Completion
Dec 31, 2028

Study Design

Enrollment
84 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: EG Fibromyalgia
    Fibromyalgia Intervention Group: Exercise and Pain Education
  • Placebo Comparator: CG Fibromyalgia
    Fibromyalgia Control Group: Exercise and Placebo Education
  • Experimental: EG Chronic Low Back Pain
    Experimental Group for Chronic Low Back Pain: Exercise and Pain Education
  • Placebo Comparator: CG Chronic Low Back Pain
    Experimental Group for Chronic Low Back Pain: Exercise and Placebo Education

Primary Outcome Measure

Level of physical activity [ Time Frame: Before the procedure, after the procedure, one month later, three months later, and six months later the procedure. ]

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