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

NCT07825506 | Enrolling By Invitation

• 1 other identifier: 260525008
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 1

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.

Conditions

Disabilities; Pain; Women; Fibromyalgia

Keywords

disabilies; Fibromyalgia; Pain; Neural mobilization; Exercise; women

Outcome Measures

Primary Outcomes (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.

  Baseline and immediately after the 4-weeks intervention period.

Secondary Outcomes (8)

• NRS -- Numeric Rating Scale

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

• PCS -- Pain Catastrophizing Scale

  Baseline and immediately after the 4-week intervention period.

• PDQ -- Pain Disability Questionnaire

  Baseline and immediately after the 4-week intervention period.

• PSEQ -- Pain Self-Efficacy Questionnaire

  Baseline and immediately after the 4-week intervention period.

• Algometry

  Baseline and immediately after the 4-week intervention period.

Study Arms (2)

Conventional Treatment

ACTIVE COMPARATOR

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)

Convencional Treatment plus Neural Mobilization

EXPERIMENTAL

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)

Interventions

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

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.

Convencional Treatment plus Neural Mobilization

Eligibility Criteria

• Age: 18 Years+
• Gender Eligibility Details: Biological female sex.
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Pontificia Universidad Catolica de Chile: lead

Study Sites (1)

Pontificia Universidad Católica de Chile

Santiago, Santiago Metropolitan, 8320000, Chile

Location

Related Publications (9)

• 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.

  PMID: 38365860 BACKGROUND

• 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.

  PMID: 28704626 BACKGROUND

• 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.

  PMID: 26143052 BACKGROUND

• 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.

  PMID: 40500865 BACKGROUND

• 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.

  PMID: 40470564 BACKGROUND

• 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.

  PMID: 36893316 BACKGROUND

• 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.

  PMID: 30211382 BACKGROUND

• 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.

  PMID: 40228833 BACKGROUND

• 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.

  PMID: 28630973 BACKGROUND

MeSH Terms

Conditions

Fibromyalgia; Pain; Motor Activity

Condition Hierarchy (Ancestors)

Muscular Diseases; Musculoskeletal Diseases; Rheumatic Diseases; Neuromuscular Diseases; Nervous System Diseases; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Behavior

Study Officials

• Gustavo Torres

  Pontificia Universidad Catolica de Chile

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Masking Details: 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.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Randomized, controlled, parallel, prospective clinical trial, with a blinded evaluator for clinical measurements.

Study Record Dates

• First Submitted: September 12, 2026
• First Posted: September 17, 2026
• Study Start: August 25, 2026
• Primary Completion (Estimated): October 30, 2026
• Study Completion (Estimated): November 25, 2026
• Last Updated: September 17, 2026

Record last verified: 2026-07

Locations

CL (1)