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FibromyalgiaNCT07825506

Fibromyalgia and Functional Impact: the Complementary Role of Neural Mobilization.

A study testing Conventional Treatment (CT) and Conventional Treatment plus Neural Mobilization (CTNM) in people with Fibromyalgia and Disabilities, run by Pontificia Universidad Catolica de Chile at 1 site in Chile.

Enrolling by invitation

Enrolling by invitation. The study team selects and invites participants, usually from an existing group of patients.

Sites and contacts
Official record
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Trial 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. Read more about this study

Who is it for?
Ages 18 years and older, women only
Conditions the study is for
Fibromyalgia, Disabilities, Pain
What is being tested?
Conventional Treatment (CT) and Conventional Treatment plus Neural Mobilization (CTNM)
Could I receive a placebo?
No, everyone receives an active treatment
How many people
20 participants
Where
1 siteChile
Study dates
25 Aug 2026to 25 Nov 2026
Phase
Interventional
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • Women only
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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.

Who cannot join

  • 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.

Trial locations and contacts

1 site in 1 country. Contact the study team or a site near you to ask about taking part.

Chile1 site

  • Pontificia Universidad Católica de Chile

    Santiago, Santiago Metropolitan, 8320000

Other trials in Chile

About this study

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.

Read the 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.

Being tested
Conventional Treatment (CT), Conventional Treatment plus Neural Mobilization (CTNM)
Keywords
disabilies, Fibromyalgia, Pain, Neural mobilization, Exercise, women
Medical subject headings
Fibromyalgia, Pain, Motor Activity

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Conventional Treatment (CT)Other

    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.

  • Conventional Treatment plus Neural Mobilization (CTNM)Other

    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.

Study groups in NCT07825506
Study groupRoleWhat they receive
Conventional TreatmentActive comparatorEducation 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.
Receives: Other: Conventional Treatment (CT)
Convencional Treatment plus Neural MobilizationExperimentalSame 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.
Receives: Other: Conventional Treatment plus Neural Mobilization (CTNM)

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. 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.

    Measured: Baseline and immediately after the 4-weeks intervention period.

Secondary outcomes (8)

  1. 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.

    Measured: Baseline and immediately after the session intervention for the 4-week intervention period.

  2. 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.

    Measured: Baseline and immediately after the 4-week intervention period.

  3. 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.

    Measured: Baseline and immediately after the 4-week intervention period.

  4. 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.

    Measured: Baseline and immediately after the 4-week intervention period.

  5. 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.

    Measured: Baseline and immediately after the 4-week intervention period.

  6. 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).

    Measured: Baseline and immediately after the 4-week intervention period.

  7. 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)

    Measured: Baseline and immediately after the 4-week intervention period.

  8. 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.

    Measured: Baseline and immediately after the 4-week intervention period.

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted17 Sep 2026
  2. Study start25 Aug 2026
  3. Primary completion30 Oct 2026 (estimated)
  4. Study completion25 Nov 2026 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Model description
Randomized, controlled, parallel, prospective clinical trial, with a blinded evaluator for clinical measurements.
Masking
Double blind
Who is masked
Participant, Investigator
Enrolment
20 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT07825506
Sponsor's protocol ID
260525008
Status last verified
Jul 2026
First submitted
12 Sep 2026
Last updated
17 Sep 2026
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
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.

Publications

  • Marshall A, Rapteas L, Burgess J, Riley D, Anson M, Matsumoto K, Bennett A, Kaye S, Marshall A, Dunham J, Fallon N, Zhao SS, Pritchard A, Goodson N, Malik RA, Goebel A, Frank B, Alam U. Small fibre pathology, small fibre symptoms and pain in fibromyalgia syndrome. Sci Rep. 2024 Feb 16;14(1):3947. doi: 10.1038/s41598-024-54365-6.

    PubMed 38365860

  • Basson A, Olivier B, Ellis R, Coppieters M, Stewart A, Mudzi W. The Effectiveness of Neural Mobilization for Neuromusculoskeletal Conditions: A Systematic Review and Meta-analysis. J Orthop Sports Phys Ther. 2017 Sep;47(9):593-615. doi: 10.2519/jospt.2017.7117. Epub 2017 Jul 13.

    PubMed 28704626

  • Torres JR, Martos IC, Sanchez IT, Rubio AO, Pelegrina AD, Valenza MC. Results of an Active Neurodynamic Mobilization Program in Patients With Fibromyalgia Syndrome: A Randomized Controlled Trial. Arch Phys Med Rehabil. 2015 Oct;96(10):1771-8. doi: 10.1016/j.apmr.2015.06.008. Epub 2015 Jul 2.

    PubMed 26143052

  • Li X, Pan H, Wang L, Zhou Q, Ma Y, Wang Q, Wang M, Xie Z, Li H, Chen L, Huang L, Chen Y, Wen C. Guidelines on Treating Fibromyalgia With Nonpharmacological Therapies in China. J Evid Based Med. 2025 Jun;18(2):e70044. doi: 10.1111/jebm.70044.

    PubMed 40500865

  • Iannuccelli C, Favretti M, Dolcini G, Di Carlo M, Pellegrino G, Bazzichi L, Atzeni F, Lucini D, Varassi G, Leoni MLG, Fornasari DMM, Conti F, Salaffi F, Sarzi-Puttini P, Di Franco M. Fibromyalgia: one year in review 2025. Clin Exp Rheumatol. 2025 Jun;43(6):957-969. doi: 10.55563/clinexprheumatol/buhd2z. Epub 2025 Jun 3.

    PubMed 40470564

  • Duran J, Tejos-Bravo M, Cid V, Ferreccio C, Calvo M. Chronic pain in Chile: first prevalence report of noncancer chronic pain, fibromyalgia, and neuropathic pain and its associated factors. Pain. 2023 Aug 1;164(8):1852-1859. doi: 10.1097/j.pain.0000000000002886. Epub 2023 Mar 9.

    PubMed 36893316

  • Delgado DA, Lambert BS, Boutris N, McCulloch PC, Robbins AB, Moreno MR, Harris JD. Validation of Digital Visual Analog Scale Pain Scoring With a Traditional Paper-based Visual Analog Scale in Adults. J Am Acad Orthop Surg Glob Res Rev. 2018 Mar 23;2(3):e088. doi: 10.5435/JAAOSGlobal-D-17-00088. eCollection 2018 Mar.

    PubMed 30211382

  • Hopewell S, Chan AW, Collins GS, Hrobjartsson A, Moher D, Schulz KF, Tunn R, Aggarwal R, Berkwits M, Berlin JA, Bhandari N, Butcher NJ, Campbell MK, Chidebe RCW, Elbourne D, Farmer A, Fergusson DA, Golub RM, Goodman SN, Hoffmann TC, Ioannidis JPA, Kahan BC, Knowles RL, Lamb SE, Lewis S, Loder E, Offringa M, Ravaud P, Richards DP, Rockhold FW, Schriger DL, Siegfried NL, Staniszewska S, Taylor RS, Thabane L, Torgerson D, Vohra S, White IR, Boutron I. CONSORT 2025 statement: updated guideline for reporting randomised trials. BMJ. 2025 Apr 14;389:e081123. doi: 10.1136/bmj-2024-081123.

    PubMed 40228833

  • Boutron I, Altman DG, Moher D, Schulz KF, Ravaud P; CONSORT NPT Group. CONSORT Statement for Randomized Trials of Nonpharmacologic Treatments: A 2017 Update and a CONSORT Extension for Nonpharmacologic Trial Abstracts. Ann Intern Med. 2017 Jul 4;167(1):40-47. doi: 10.7326/M17-0046. Epub 2017 Jun 20.

    PubMed 28630973

Questions about this trial

What is this clinical trial studying?

A study testing Conventional Treatment (CT) and Conventional Treatment plus Neural Mobilization (CTNM) in people with Fibromyalgia and Disabilities, run by Pontificia Universidad Catolica de Chile at 1 site in Chile.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 4 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: enrolling by invitation, as of the sponsor's last update on 17 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Chile. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

FIQR - Revised Fibromyalgia Impact Questionnaire (time frame: Baseline and immediately after the 4-weeks intervention period.). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT07825506, which also lists 9 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 17 Sep 2026.

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