Unilateral and Bilateral taVNS in Fibromyalgia (taVNS-FMS)
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.
Descripción general del estudio
Estado
Condiciones
Intervención / Tratamiento
Descripción detallada
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.
Tipo de estudio
Inscripción (Actual)
Fase
- No aplica
Contactos y Ubicaciones
Ubicaciones de estudio
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Istanbul, Turquía (Türkiye)
- Darülaceze Medical Center
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Criterios de participación
Criterio de elegibilidad
Edades elegibles para estudiar
- Adulto
Acepta Voluntarios Saludables
Descripción
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
Plan de estudios
¿Cómo está diseñado el estudio?
Detalles de diseño
- Propósito principal: Tratamiento
- Asignación: Aleatorizado
- Modelo Intervencionista: Asignación paralela
- Enmascaramiento: Ninguno (etiqueta abierta)
Armas e Intervenciones
Grupo de participantes/brazo |
Intervención / Tratamiento |
|---|---|
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Experimental: Unilateral taVNS
Participants received unilateral (left-sided) transcutaneous auricular vagus nerve stimulation (taVNS) for ten sessions over a two-week period.
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Transcutaneous auricular vagus nerve stimulation applied via the auricular branch of the vagus nerve for neuromodulation purposes.
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Experimental: Bilateral taVNS
Participants received bilateral transcutaneous auricular vagus nerve stimulation (taVNS) for ten sessions over a two-week period.
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Transcutaneous auricular vagus nerve stimulation applied via the auricular branch of the vagus nerve for neuromodulation purposes.
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Comparador activo: Home Exercise Program
Participants followed a structured home-based exercise program for two weeks.
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A structured home-based exercise program including strengthening and mobility exercises performed over a two-week period.
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¿Qué mide el estudio?
Medidas de resultado primarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
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Exercise performance (repetition count)
Periodo de tiempo: Baseline (Week 0) and Week 2
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Number of repetitions performed during exercise sessions to evaluate functional exercise performance.
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Baseline (Week 0) and Week 2
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Medidas de resultado secundarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
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Fibromyalgia Impact Questionnaire (FIQ) score
Periodo de tiempo: Baseline (Week 0) and Week 2
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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.
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Baseline (Week 0) and Week 2
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Beck Anxiety Inventory (BAI) score
Periodo de tiempo: Baseline (Week 0) and Week 2
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Change in Beck Anxiety Inventory (BAI) score (range: 0-63; higher scores indicate greater anxiety levels) to assess anxiety severity.
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Baseline (Week 0) and Week 2
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Beck Depression Inventory (BDI) score
Periodo de tiempo: Baseline (Week 0) and Week 2
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Change in Beck Depression Inventory (BDI) score (range: 0-63; higher scores indicate more severe depressive symptoms) to assess depression severity.
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Baseline (Week 0) and Week 2
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Pittsburgh Sleep Quality Index (PSQI) score
Periodo de tiempo: Baseline (Week 0) and Week 2
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Change in Pittsburgh Sleep Quality Index (PSQI) score (range: 0-21; higher scores indicate worse sleep quality) to assess sleep quality.
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Baseline (Week 0) and Week 2
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Heart Rate Variability (RMSSD)
Periodo de tiempo: Week 0 pre-exercise measurement, Week 0 post-exercise measurement, Week 2 pre-exercise measurement, and Week 2 post-exercise measurement
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Change in RMSSD (ms), reflecting parasympathetic activity.
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Week 0 pre-exercise measurement, Week 0 post-exercise measurement, Week 2 pre-exercise measurement, and Week 2 post-exercise measurement
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Heart Rate Variability (pNN50)
Periodo de tiempo: Week 0 pre-exercise measurement, Week 0 post-exercise measurement, Week 2 pre-exercise measurement, and Week 2 post-exercise measurement
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Change in pNN50 (%), representing parasympathetic modulation.
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Week 0 pre-exercise measurement, Week 0 post-exercise measurement, Week 2 pre-exercise measurement, and Week 2 post-exercise measurement
|
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Heart Rate Variability (HF power)
Periodo de tiempo: Week 0 pre-exercise measurement, Week 0 post-exercise measurement, Week 2 pre-exercise measurement, and Week 2 post-exercise measurement
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Change in high-frequency (HF) power (ms²), reflecting parasympathetic nervous system activity.
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Week 0 pre-exercise measurement, Week 0 post-exercise measurement, Week 2 pre-exercise measurement, and Week 2 post-exercise measurement
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Heart Rate Variability (LF power)
Periodo de tiempo: Week 0 pre-exercise measurement, Week 0 post-exercise measurement, Week 2 pre-exercise measurement, and Week 2 post-exercise measurement
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Change in low-frequency (LF) power (ms²), reflecting mixed sympathetic and parasympathetic activity.
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Week 0 pre-exercise measurement, Week 0 post-exercise measurement, Week 2 pre-exercise measurement, and Week 2 post-exercise measurement
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Heart Rate Variability (LF/HF ratio)
Periodo de tiempo: Week 0 pre-exercise measurement, Week 0 post-exercise measurement, Week 2 pre-exercise measurement, and Week 2 post-exercise measurement
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Change in LF/HF ratio (unitless), indicating autonomic balance between sympathetic and parasympathetic systems.
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Week 0 pre-exercise measurement, Week 0 post-exercise measurement, Week 2 pre-exercise measurement, and Week 2 post-exercise measurement
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Colaboradores e Investigadores
Patrocinador
Colaboradores
Investigadores
- Investigador principal: Kerem KARAGÖZ, PhD, Bahçeşehir University
Fechas de registro del estudio
Fechas importantes del estudio
Inicio del estudio (Actual)
Finalización primaria (Actual)
Finalización del estudio (Actual)
Fechas de registro del estudio
Enviado por primera vez
Primero enviado que cumplió con los criterios de control de calidad
Publicado por primera vez (Actual)
Actualizaciones de registros de estudio
Última actualización publicada (Actual)
Última actualización enviada que cumplió con los criterios de control de calidad
Última verificación
Más información
Términos relacionados con este estudio
Palabras clave
Términos MeSH relevantes adicionales
Otros números de identificación del estudio
- FMS-taVNS-2022-01
Plan de datos de participantes individuales (IPD)
¿Planea compartir datos de participantes individuales (IPD)?
Descripción del plan IPD
Información sobre medicamentos y dispositivos, documentos del estudio
Estudia un producto farmacéutico regulado por la FDA de EE. UU.
Estudia un producto de dispositivo regulado por la FDA de EE. UU.
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