Disabilities, Fibromyalgia, Pain, Women
Conditions
Keywords
disabilies, Fibromyalgia, Pain, Neural mobilization, Exercise, women
Brief summary
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.
Detailed description
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.
Interventions
OTHERConventional Treatment (CT)
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.
OTHERConventional Treatment plus Neural Mobilization (CTNM)
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.
Sponsors
Pontificia Universidad Catolica de Chile
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Investigator)
Masking description
The treating kinesiologists won't be blinded by the nature of the intervention, but the evaluations will be carried out by staff different from the treatment team.
Intervention model description
Randomized, controlled, parallel, prospective clinical trial, with a blinded evaluator for clinical measurements.
Eligibility
Sex/Gender
FEMALE
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Women aged 18 or older. * Medical diagnosis of fibromyalgia. * Ability to understand the study and sign informed consent. * Stable drug treatment for the 4 weeks prior.
Exclusion criteria
* Pregnancy. * Active cancer or unstable systemic disease. * Severe decompensated psychiatric disorder. * Active substance dependence. * Inability to participate in therapeutic exercise or complete evaluations. * For the subsample with biopsy: use of anticoagulants, allergy to lidocaine, or active infection at the site.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| FIQR - Revised Fibromyalgia Impact Questionnaire | Baseline and immediately after the 4-weeks intervention period. | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| NRS -- Numeric Rating Scale | Baseline and immediately after the session intervention for the 4-week intervention period. | 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. |
| PCS -- Pain Catastrophizing Scale | Baseline and immediately after the 4-week intervention period. | 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. |
| PDQ -- Pain Disability Questionnaire | Baseline and immediately after the 4-week intervention period. | 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. |
| PSEQ -- Pain Self-Efficacy Questionnaire | Baseline and immediately after the 4-week intervention period. | 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. |
| Algometry | Baseline and immediately after the 4-week intervention period. | 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. |
| Dinamometry | Baseline and immediately after the 4-week intervention period. | 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). |
| IENFD -- density of intraepidermal nerve fibers. | Baseline and immediately after the 4-week intervention period. | 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) |
| QST -- Quantitative Sensory Testing. | Baseline and immediately after the 4-week intervention period. | 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. |
Countries
Chile
Contacts
PRINCIPAL_INVESTIGATORGustavo Torres
Pontificia Universidad Catolica de Chile
Outcome results
None listed