An interventional study of Conventional Treatment (CT) and Conventional Treatment plus Neural Mobilization (CTNM) in Fibromyalgia, Disabilities and Pain, sponsored by Pontificia Universidad Catolica de Chile. Enrolling by invitation at 1 site in Chile. Open to female participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-09-17.
Sponsored by Pontificia Universidad Catolica de Chile · Not applicable, Interventional, and Treatment
This study aims to compare the change in overall impact and functional variables of fibromyalgia between a group receiving conventional treatment plus neural mobilization and a group receiving only conventional treatment over 12 weeks.
Fibromyalgia is a syndrome of chronic widespread pain with a high clinical and functional impact, characterized by persistent multisite pain, fatigue, sleep disturbances, cognitive symptoms, and reduced quality of life. In Chile, the estimated prevalence of fibromyalgia was reported to be 3.3% in the most recent national report on chronic pain, with a higher frequency in women. Despite advances in clinical recognition, diagnostic and therapeutic challenges persist, and a significant proportion of patients continue to experience pain and disability despite usual treatment. Current recommendations emphasize non-pharmacological and multidisciplinary management, especially education, therapeutic exercise, and self-management strategies. However, clinical response is variable, and there is still interest in identifying complementary interventions that improve the functional impact of the disease.Neural mobilization has shown benefits in neuromusculoskeletal conditions, and only one randomized clinical trial has been conducted in patients with fibromyalgia, reporting improvements in pain, fatigue, neurodynamic range, and functional status; however, the results were only evaluated after 8 weeks (short term), and the assessments were limited to questionnaires, pain intensity, and range in neurodynamic tests, without evaluating functionality with objective tests. On the other hand, it's very important to highlight that the clinical study carried out in 2014 looked at neural mobilization as an isolated therapy and was compared with a control group that only received education, without any active intervention or real therapeutic treatment. With all this background, we can say that the evidence for neurodynamics is still very limited, its long-term effects are unclear, and it's not well integrated into real physiotherapy programs in our setting.
1,243 studies on the registry are indexed under Fibromyalgia; 256 are open to participants now.
This study's planned enrollment of 20 is below the median of 60 across 937 interventional studies indexed under Fibromyalgia.
Browse Fibromyalgia studies →Pontificia Universidad Catolica de Chile is the lead sponsor of 224 studies on the registry; 59 are open to participants now.
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Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
A biopsy takes a small piece of tissue to examine. “Archival tissue” is a sample already taken, for example at diagnosis, and kept by the hospital.
Whether a stored sample will do depends on when it was taken, how much there is and what the study needs. Ask whether the study accepts your stored sample or needs a new biopsy.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Biopsy and archival tissue
A biopsy takes a small piece of tissue to examine. “Archival tissue” is a sample already taken, for example at diagnosis, and kept by the hospital.
Whether a stored sample will do depends on when it was taken, how much there is and what the study needs. Ask whether the study accepts your stored sample or needs a new biopsy.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Education about pain and fibromyalgia, activity dosing, progressive therapeutic exercise (aerobic, strengthening, and mobility), and a home plan. Both groups will have the following materials and instruments: Instruments and materials: numeric pain scale/EVA, Revised Fibromyalgia Impact Questionnaire (FIQR), Pain Disability Questionnaire (PDQ), Pain Catastrophizing Scale, Chronic Pain Self-Efficacy Scale (or an equivalent validated instrument in Spanish), hand dynamometer, and pressure algometer. In a voluntary subsample, standardized QST will be applied, and a 3 mm punch skin biopsy will be offered, with additional specific consent, to obtain the sensory profile and quantify epidermal sensory fibers.
Other: Conventional Treatment (CT)
Same conventional program plus standardized neural mobilization techniques, mainly of the 'slider' type, and progression according to clinical tolerance. Both groups will receive the same number and duration of sessions. Both groups will have the following materials and instruments: Instruments and materials: numeric pain scale/EVA, Revised Fibromyalgia Impact Questionnaire (FIQR), Pain Disability Questionnaire (PDQ), Pain Catastrophizing Scale, Chronic Pain Self-Efficacy Scale (or an equivalent validated instrument in Spanish), hand dynamometer, and pressure algometer. In a voluntary subsample, standardized QST will be applied, and a 3 mm punch skin biopsy will be offered, with additional specific consent, to obtain the sensory profile and quantify epidermal sensory fibers.
Other: Conventional Treatment plus Neural Mobilization (CTNM)
The intervention protocol was structured around a progressive "traffic light" model (red, yellow, and green) that takes into account the patients' pain levels and tolerance for movement. This approach is based on current recommendations for chronic pain management, which suggest adjusting the therapeutic load according to nervous system irritability to optimize clinical outcomes and prevent symptom flare-ups. Individualized load dosing has been shown to foster treatment adherence and improve functional outcomes, particularly in conditions characterized by central sensitization, such as fibromyalgia. In this context, the gradual progression of mechanical stimuli is a key rehabilitation principle, allowing for the progressive adaptation of tissues and the nervous system to increasing demands. The conventional group will receive a conventional physical therapy program based on aerobic, strength, and flexibility exercises, as well as pain education. Each session will last 60 minutes.
The intervention protocol is based on the same "traffic light" system used for the conventional group and the battery of components of protocol like: aerobic, strength, and flexibility exercise, and pain education. Regarding neural mobilization, sliding techniques ("sliders") have been described as generating lower levels of neural tension and being better tolerated during phases of high irritability, whereas tensioning techniques ("tensioners") increase mechanical load on the nervous system and are employed in later stages of treatment. Thus, starting with low-mechanical-load interventions focused on neural sliding and progressing to techniques incorporating longitudinal tension, rotational components, and global movements aligns with neurodynamic principles widely described in the literature. In addition to conventional treatment, this group will incorporate neural mobilization techniques organized according to the "traffic light" model.
FIQR - Revised Fibromyalgia Impact Questionnaire
It's a medical and psychological tool specifically designed to assess and measure the impact fibromyalgia has on daily life, well-being, and patients' functional capacity. It's an update of the original FIQ questionnaire (created in 1991). It was modified to be easier to answer, simpler for doctors to score, and to include modern symptoms that were overlooked in the first version.This quiz has a score from 0 to 100.
Time frame: Baseline and immediately after the 4-weeks intervention period.
NRS -- Numeric Rating Scale
It is one of the most commonly used medical tools worldwide for quickly and easily measuring the intensity of a patient's pain. It consists of a numbered line from 0 to 10, where the patient chooses the number that best represents the strength or severity of their current pain. 0: Means a total absence of pain ("No pain"). 10: Represents the worst pain imaginable or the most intense pain the patient has ever felt.
Time frame: Baseline and immediately after the session intervention for the 4-week intervention period.
PCS -- Pain Catastrophizing Scale
It's a psychological and medical questionnaire designed to measure the overly negative cognitive and emotional responses a person has to actual or anticipated pain. The total scale score ranges from 0 to 52 points. Low scores indicate a more resilient or adaptive attitude toward pain. A score of 30 or more is considered the clinical cutoff point for severe catastrophizing.
Time frame: Baseline and immediately after the 4-week intervention period.
PDQ -- Pain Disability Questionnaire
It's a self-report tool designed to measure how and how intensely pain interferes with a person's daily life and functional ability. Unlike scales that only measure how much it hurts (like the NRS), the PDQ takes a biopsychosocial approach. This means it helps doctors understand how physical pain affects both body tasks and the patient's emotional and social well-being. By adding up the scores from all the questions, you get a total score that ranges from 0 to 150 points.
Time frame: Baseline and immediately after the 4-week intervention period.
PSEQ -- Pain Self-Efficacy Questionnaire
It's a psychological and medical assessment tool designed to measure how confident a patient is in their own ability to carry out various daily activities despite experiencing chronic pain. Unlike other scales that measure fear or disability, the PSEQ evaluates the patient's resilience and sense of control over their life in the face of illness. By adding up the answers to the 10 questions, you get a total score that ranges from 0 to 60 points.
Time frame: Baseline and immediately after the 4-week intervention period.
Algometry
Algometry (also known as dolorimetry) is a clinical and research method used to measure and quantify a patient's sensitivity and physical pain threshold objectively. Unlike questionnaires that rely entirely on the patient's verbal perception (like the NRS scale), algometry uses a mechanical or digital device called an algometer to apply a controlled physical stimulus (usually pressure) and record precise mathematical data. The most common type is pressure algometry, widely used in physiotherapy, rheumatology, and pain units.
Time frame: Baseline and immediately after the 4-week intervention period.
Dinamometry
Dynamometry is a clinical and sports method used to measure muscle strength in an objective, precise, and quantifiable way. To carry it out, a mechanical or digital instrument called a dynamometer is used, which records the amount of physical force (usually measured in kilograms or Newtons) that a muscle group can generate during a maximum voluntary contraction. The most common and standardized type in medical practice is hand or palmar grip dynamometry (handgrip).
Time frame: Baseline and immediately after the 4-week intervention period.
IENFD -- density of intraepidermal nerve fibers.
The density of intraepidermal nerve fibers (IENFD), assessed through a skin biopsy, is a diagnostic test considered the gold standard for identifying small fiber neuropathy (SFN). Unlike conventional electromyographies that only analyze the big nerves, this test lets doctors directly count how many microscopic nerve endings (A-delta and C fibers) are still alive in the outermost layer of the skin (the epidermis)
Time frame: Baseline and immediately after the 4-week intervention period.
QST -- Quantitative Sensory Testing.
It's a non-invasive medical test that's used to accurately measure how a patient's somatosensory system (the nerves for touch, cold, heat, and pain) works. Unlike traditional neurological exams where the doctor pokes the skin with a needle and asks 'Do you feel this?', QST uses computer-calibrated physical stimuli to precisely determine the patient's exact perception and pain threshold.
Time frame: Baseline and immediately after the 4-week intervention period.
Plan to share: Undecided — The small sample size of the study may limit the ability to fully ensure participant confidentiality if individual-level data were to be shared.
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