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Unilateral and Bilateral taVNS in Fibromyalgia (taVNS-FMS)

5. mai 2026 oppdatert av: BUSENUR KARAGÖZ, Istanbul Gelisim University

Comparison of Unilateral and Bilateral Transcutaneous Auricular Vagus Nerve Stimulation on Autonomic Function and Exercise Performance in Fibromyalgia

This randomized controlled trial aimed to compare the effects of unilateral (left-sided) and bilateral transcutaneous auricular vagus nerve stimulation (taVNS) combined with a home exercise program on clinical outcomes, autonomic nervous system function, and exercise performance in individuals with fibromyalgia syndrome (FMS).

Participants diagnosed with fibromyalgia were randomly assigned to one of three groups: unilateral taVNS, bilateral taVNS, or a home exercise program. The intervention period lasted two weeks and included ten treatment sessions. Clinical outcomes were assessed using validated scales including the Fibromyalgia Impact Questionnaire (FIQ), Beck Anxiety Inventory (BAI), Beck Depression Inventory (BDI), and Pittsburgh Sleep Quality Index (PSQI). Autonomic function was evaluated using heart rate variability (HRV) parameters, and exercise performance was assessed based on repetition capacity.

The study aimed to determine whether bilateral stimulation provides additional benefits compared to unilateral stimulation and exercise alone. The findings may contribute to understanding the role of neuromodulation strategies in improving autonomic regulation, symptom severity, and functional performance in individuals with fibromyalgia.

Studieoversikt

Status

Fullført

Forhold

Intervensjon / Behandling

Detaljert beskrivelse

Fibromyalgia syndrome (FMS) is a chronic condition characterized by widespread pain, fatigue, sleep disturbances, and psychological symptoms, often associated with autonomic nervous system dysfunction. Reduced heart rate variability (HRV) and increased sympathetic activity are commonly observed in individuals with FMS, contributing to impaired exercise tolerance and reduced quality of life.

Transcutaneous auricular vagus nerve stimulation (taVNS) is a non-invasive neuromodulation technique that targets the auricular branch of the vagus nerve and has been shown to influence autonomic regulation and central pain processing. However, evidence regarding its effects on exercise performance and the comparative efficacy of unilateral versus bilateral stimulation remains limited.

This study was designed as a randomized controlled trial including individuals diagnosed with fibromyalgia. Participants were allocated into three groups: unilateral taVNS, bilateral taVNS, and a home exercise program. The interventions were applied over a two-week period consisting of ten sessions. The taVNS intervention was administered via auricular stimulation targeting vagal afferents, while the exercise group followed a structured home-based program.

Outcome measures included clinical symptom scales (FIQ, BAI, BDI, PSQI), autonomic nervous system parameters derived from HRV analysis (including RMSSD, pNN50, LF, HF, and LF/HF ratio), and exercise performance assessed through repetition capacity. Assessments were conducted before and after the intervention period.

The primary objective was to compare the effects of unilateral and bilateral taVNS on autonomic function and exercise performance, and to evaluate whether combining neuromodulation with exercise provides additional clinical benefits in individuals with fibromyalgia. The results of this study may help inform rehabilitation strategies integrating neuromodulation and exercise-based interventions.

Studietype

Intervensjonell

Registrering (Faktiske)

90

Fase

  • Ikke aktuelt

Kontakter og plasseringer

Denne delen inneholder kontaktinformasjon for de som utfører studien, og informasjon om hvor denne studien blir utført.

Studiesteder

Deltakelseskriterier

Forskere ser etter personer som passer til en bestemt beskrivelse, kalt kvalifikasjonskriterier. Noen eksempler på disse kriteriene er en persons generelle helsetilstand eller tidligere behandlinger.

Kvalifikasjonskriterier

Alder som er kvalifisert for studier

  • Voksen

Tar imot friske frivillige

Nei

Beskrivelse

Inclusion Criteria:

  • Were between 18 and 45 years of age

  • Were diagnosed with fibromyalgia according to the 2016 ACR diagnostic criteria

    -- Stable clinical condition

  • Ability to understand and follow study procedures
  • Willingness to participate and provide informed consent

Exclusion Criteria:

  • A history of malignancy
  • Cardiopulmonary diseases contraindicating exercise
  • Limb loss
  • Ear infections and implants, implanted electronic devices
  • Systemic diseases (hematological, endocrine, rheumatological, renal, cardiovascular, gastrointestinal, neurological, or autoimmune diseases)
  • Active infection
  • Surgery or major trauma within the previous 6 months
  • Postmenopausal status
  • Pregnancy or lactation

Studieplan

Denne delen gir detaljer om studieplanen, inkludert hvordan studien er utformet og hva studien måler.

Hvordan er studiet utformet?

Designdetaljer

  • Primært formål: Behandling
  • Tildeling: Randomisert
  • Intervensjonsmodell: Parallell tildeling
  • Masking: Ingen (Open Label)

Våpen og intervensjoner

Deltakergruppe / Arm
Intervensjon / Behandling
Eksperimentell: Unilateral taVNS
Participants received unilateral (left-sided) transcutaneous auricular vagus nerve stimulation (taVNS) for ten sessions over a two-week period.
Enhet: taVNS
Transcutaneous auricular vagus nerve stimulation applied via the auricular branch of the vagus nerve for neuromodulation purposes.
Eksperimentell: Bilateral taVNS
Participants received bilateral transcutaneous auricular vagus nerve stimulation (taVNS) for ten sessions over a two-week period.
Enhet: taVNS
Transcutaneous auricular vagus nerve stimulation applied via the auricular branch of the vagus nerve for neuromodulation purposes.
Aktiv komparator: Home Exercise Program
Participants followed a structured home-based exercise program for two weeks.
Atferdsmessig: Home Exercise Program
A structured home-based exercise program including strengthening and mobility exercises performed over a two-week period.

Hva måler studien?

Primære resultatmål

Resultatmål
Tiltaksbeskrivelse
Tidsramme
Exercise performance (repetition count)
Tidsramme: Baseline (Week 0) and Week 2
Number of repetitions performed during exercise sessions to evaluate functional exercise performance.
Baseline (Week 0) and Week 2

Sekundære resultatmål

Resultatmål
Tiltaksbeskrivelse
Tidsramme
Fibromyalgia Impact Questionnaire (FIQ) score
Tidsramme: Baseline (Week 0) and Week 2
Change in Fibromyalgia Impact Questionnaire (FIQ) score (range: 0-100; higher scores indicate worse disease severity and functional impairment) to assess disease severity and functional status in patients with fibromyalgia.
Baseline (Week 0) and Week 2
Beck Anxiety Inventory (BAI) score
Tidsramme: Baseline (Week 0) and Week 2
Change in Beck Anxiety Inventory (BAI) score (range: 0-63; higher scores indicate greater anxiety levels) to assess anxiety severity.
Baseline (Week 0) and Week 2
Beck Depression Inventory (BDI) score
Tidsramme: Baseline (Week 0) and Week 2
Change in Beck Depression Inventory (BDI) score (range: 0-63; higher scores indicate more severe depressive symptoms) to assess depression severity.
Baseline (Week 0) and Week 2
Pittsburgh Sleep Quality Index (PSQI) score
Tidsramme: Baseline (Week 0) and Week 2
Change in Pittsburgh Sleep Quality Index (PSQI) score (range: 0-21; higher scores indicate worse sleep quality) to assess sleep quality.
Baseline (Week 0) and Week 2
Heart Rate Variability (RMSSD)
Tidsramme: Week 0 pre-exercise measurement, Week 0 post-exercise measurement, Week 2 pre-exercise measurement, and Week 2 post-exercise measurement
Change in RMSSD (ms), reflecting parasympathetic activity.
Week 0 pre-exercise measurement, Week 0 post-exercise measurement, Week 2 pre-exercise measurement, and Week 2 post-exercise measurement
Heart Rate Variability (pNN50)
Tidsramme: Week 0 pre-exercise measurement, Week 0 post-exercise measurement, Week 2 pre-exercise measurement, and Week 2 post-exercise measurement
Change in pNN50 (%), representing parasympathetic modulation.
Week 0 pre-exercise measurement, Week 0 post-exercise measurement, Week 2 pre-exercise measurement, and Week 2 post-exercise measurement
Heart Rate Variability (HF power)
Tidsramme: Week 0 pre-exercise measurement, Week 0 post-exercise measurement, Week 2 pre-exercise measurement, and Week 2 post-exercise measurement
Change in high-frequency (HF) power (ms²), reflecting parasympathetic nervous system activity.
Week 0 pre-exercise measurement, Week 0 post-exercise measurement, Week 2 pre-exercise measurement, and Week 2 post-exercise measurement
Heart Rate Variability (LF power)
Tidsramme: Week 0 pre-exercise measurement, Week 0 post-exercise measurement, Week 2 pre-exercise measurement, and Week 2 post-exercise measurement
Change in low-frequency (LF) power (ms²), reflecting mixed sympathetic and parasympathetic activity.
Week 0 pre-exercise measurement, Week 0 post-exercise measurement, Week 2 pre-exercise measurement, and Week 2 post-exercise measurement
Heart Rate Variability (LF/HF ratio)
Tidsramme: Week 0 pre-exercise measurement, Week 0 post-exercise measurement, Week 2 pre-exercise measurement, and Week 2 post-exercise measurement
Change in LF/HF ratio (unitless), indicating autonomic balance between sympathetic and parasympathetic systems.
Week 0 pre-exercise measurement, Week 0 post-exercise measurement, Week 2 pre-exercise measurement, and Week 2 post-exercise measurement

Samarbeidspartnere og etterforskere

Det er her du vil finne personer og organisasjoner som er involvert i denne studien.

Sponsor

Istanbul Gelisim University

Samarbeidspartnere

Bahçeşehir University

Etterforskere

  • Hovedetterforsker: Kerem KARAGÖZ, PhD, Bahçeşehir University

Studierekorddatoer

Disse datoene sporer fremdriften for innsending av studieposter og sammendragsresultater til ClinicalTrials.gov. Studieposter og rapporterte resultater gjennomgås av National Library of Medicine (NLM) for å sikre at de oppfyller spesifikke kvalitetskontrollstandarder før de legges ut på det offentlige nettstedet.

Studer hoveddatoer

Studiestart (Faktiske)

1. januar 2022

Primær fullføring (Faktiske)

20. juni 2023

Studiet fullført (Faktiske)

20. juni 2023

Datoer for studieregistrering

Først innsendt

28. april 2026

Først innsendt som oppfylte QC-kriteriene

5. mai 2026

Først lagt ut (Faktiske)

11. mai 2026

Oppdateringer av studieposter

Sist oppdatering lagt ut (Faktiske)

11. mai 2026

Siste oppdatering sendt inn som oppfylte QC-kriteriene

5. mai 2026

Sist bekreftet

1. mai 2026

Mer informasjon

Begreper knyttet til denne studien

Nøkkelord

Ytterligere relevante MeSH-vilkår

Andre studie-ID-numre

  • FMS-taVNS-2022-01

Plan for individuelle deltakerdata (IPD)

Planlegger du å dele individuelle deltakerdata (IPD)?

NEI

IPD-planbeskrivelse

Individual participant data (IPD) will not be shared due to ethical and privacy considerations. The study involves a limited sample size, and participants did not consent to data sharing beyond the scope of this research.

Legemiddel- og utstyrsinformasjon, studiedokumenter

Studerer et amerikansk FDA-regulert medikamentprodukt

Nei

Studerer et amerikansk FDA-regulert enhetsprodukt

Nei

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