Clinical Research Directory

Effects of Adding Vagal Neuromodulation to Manual Therapy in Women With Fibromyalgia

The aim of this study is to investigate the effect of transcutaneous auricular vagus nerve stimulation (taVNS) added to manual therapy on pain, autonomic nervous system function, and illness perception in female patients diagnosed with fibromyalgia, using a randomized sham-controlled design.

Multisite Transcutaneous Electrical Nerve Stimulation in Fibromyalgia: A Randomized, Double-Blind, Sham-Controlled Crossover Trial Comparing Two Stimulation Modalities

Fibromyalgia is a chronic and multifactorial disorder characterized by widespread musculoskeletal pain, heightened pain sensitivity, fatigue, sleep disturbances, cognitive complaints, and affective symptoms such as anxiety and depression. Despite the availability of pharmacological and non-pharmacological interventions, symptom control often remains suboptimal, and currently available treatments may be associated with limited efficacy or poor tolerability. Consequently, there is a growing need for effective, safe, and personalized non-pharmacological therapeutic approaches. In a previous randomized controlled trial (EXOFIB), we investigated the effects of the Exopulse Mollii Suit, a non-invasive neuromodulation device delivering multisite transcutaneous electrical nerve stimulation (TENS), in patients with fibromyalgia. Using stimulation parameters consisting of a frequency of 20 Hz, a voltage of 20 V, and a pulse width of 55-85 µs, active stimulation was associated with clinically meaningful improvements in pain, fatigue, and quality of life compared with sham stimulation. These findings provided evidence supporting the therapeutic potential of the Exopulse Mollii Suit in the management of fibromyalgia-related symptoms. However, while EXOFIB established the efficacy of active stimulation relative to sham stimulation, it did not address whether alternative stimulation parameter configurations could yield superior clinical outcomes. To date, no randomized crossover study has directly compared different active stimulation settings of the Exopulse Mollii Suit in patients with fibromyalgia. Consequently, the optimal stimulation parameters for maximizing therapeutic benefit in this population remain unknown. The present study has therefore been designed to compare the effects of three stimulation modalities delivered by the Exopulse Mollii Suit, including two active stimulation configurations and one sham stimulation condition. The primary objective is to evaluate and compare their effects on functional disability associated with fibromyalgia, assessed using the Fibromyalgia Impact Questionnaire (FIQ). The inclusion of a sham condition allows assessment of non-specific effects while preserving participant blinding. The stimulation conditions evaluated in this study are: * Condition A (active stimulation): frequency 20 Hz, voltage 20 V, pulse width 55-85 µs; * Condition B (active stimulation): frequency 20 Hz, voltage 20 V, pulse width 100-125 µs; * Condition C (sham stimulation): brief initial active stimulation followed by discontinuation of stimulation after one minute, while maintaining identical device settings, session duration, and study procedures in order to preserve participant blinding. By identifying the most effective stimulation setting, this study aims to optimize the clinical use of the Exopulse Mollii Suit in fibromyalgia and to contribute to the development of more individualized neuromodulation strategies. Ultimately, the findings may improve symptom management, reduce functional disability, and enhance quality of life in patients living with fibromyalgia.

Effects of Reiki Therapy in Women With Fibromyalgia

The goal of this randomized clinical trial is to evaluate the effects of a 4-week Reiki therapy program in women with fibromyalgia. The main questions it aims to answer are: Does Reiki therapy lead to a greater change in pain intensity compared with a placebo intervention after 4 weeks of treatment? Does Reiki therapy lead to a greater change in the impact of fibromyalgia compared with a placebo intervention after 4 weeks of treatment? Researchers will also evaluate whether Reiki therapy affects depressive symptoms, anxiety symptoms, sleep quality, and acute changes in pain intensity, heart rate, and respiratory rate. Researchers will compare participants receiving Reiki therapy with participants receiving a placebo intervention to determine whether changes in these outcomes differ between groups. Participants will: be randomly assigned to either the Reiki therapy group or the placebo group; receive one 30-minute intervention session per week for 4 weeks; complete assessments of pain intensity, fibromyalgia impact, depressive symptoms, anxiety symptoms, and sleep quality before and after the 4-week intervention period; have pain intensity, heart rate, and respiratory rate assessed immediately before and after each intervention session to evaluate acute responses.

Efficacy of TECAR Therapy in Patients With Fibromyalgia

A total of 46 patients aged 18-65 years diagnosed with fibromyalgia according to the 2016 ACR criteria, whose most painful region was axial (neck, back, or lower back), were included in the study and randomly assigned upon admission into treatment ($n=23$) and sham control ($n=23$) groups. The treatment group received real TECAR therapy using the BTL-6000 TR Therapy Pro device for a total of 6 sessions over 3 weeks at a frequency of 2 days per week (each 30-minute session consisting of 10 minutes of capacitive and 5 minutes of resistive modes applied to each of the 2 most painful regions), while the control group underwent the exact same protocol applied as sham therapy at 1% power in pulsed mode.