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Enrolling By Invitation
NCT07693998
Pain Neuroscience Education for Chronic Pain
Conditions: Fibromyalgia (FM), Chronic Low Back Pain (CLBP), Chronic Pain
Sex: All
Ages: 18 Years – N/A
Healthy volunteers: No
Phase: NA
Enrollment: 84
Sponsor: University of Valencia
Location: Facultat de Fisioteràpia Valencia Valencia
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.
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
Source: ClinicalTrials.gov (NCT07693998). StuddyBuddy aggregates publicly available trial information.