None listed
Conditions
Brief summary
This study aims to investigate whether a non-invasive neuromodulation technique can help reduce pain and improve related symptoms in people with fibromyalgia. Fibromyalgia is a chronic condition characterized by widespread musculoskeletal pain, fatigue, poor sleep, and psychological symptoms such as anxiety and stress. Conventional treatments often provide limited relief, and new complementary approaches are needed. In this randomized, triple-blind, placebo-controlled trial, 42 adult participants diagnosed with fibromyalgia will be randomly assigned to receive either active neuromodulation or sham stimulation. The active treatment uses the NESA device system, a certified medical device that delivers very low-intensity microcurrents through electrodes placed on the hands and feet. The stimulation is painless and aims to modulate the autonomic nervous system, especially the vagus nerve, which is involved in inflammation and pain regulation. Participants will undergo three sessions per week for nine weeks (28 sessions in total). Outcomes will include pain intensity (measured by a visual analogue scale), anxiety (GAD-7), perceived stress (PSS-10), sleep quality (PSQI), heart rate variability (HRV), and the impact of fibromyalgia (FIQ). Measurements will be taken before, during, and after the intervention. The results of this study may help determine whether non-invasive neuromodulation is an effective complementary therapy for reducing pain and improving quality of life in patients with fibromyalgia.
Interventions
Participants allocated to the intervention will receive non-invasive microcurrent neuromodulation with the NESA device system, applied via surface electrodes on both hands and feet, plus a directing electrode positioned over the cervical region (C6–C7) according to the standard montage. Each session lasts 60 minutes, 3 times per week, over 9 weeks (28 sessions total).
Microcurrent parameters: frequencies within 1–15 Hz, delivered as bioelectric pulse trains (up to ~19,000 pulses/min). Frequency
Participants allocated to the intervention will receive non-invasive microcurrent neuromodulation with the NESA device system, applied via surface electrodes on both hands and feet, plus a directing electrode positioned over the cervical region (C6–C7) according to the standard montage. Each session lasts 60 minutes, 3 times per week, over 9 weeks (28 sessions total). Microcurrent parameters: frequencies within 1–15 Hz, delivered as bioelectric pulse trains (up to ~19,000 pulses/min). Frequency may be fixed or variable within this range depending on the program. (Device intensity limits per manufacturer; no current sensation is expected.) Provider: The intervention is delivered by licensed physiotherapists trained in the clinical use of the NESA system and not involved in outcome assessment. Treatment phases and within-session programming (objective schedule): Phase 1 (3 sessions; Week 1; directing electrode at C6–C7): P1: 15 min. P2: 15 min. P7: 15 min. P8: 15 min. (total 60 min.). Phase 2 (20 sessions; directing electrode at C6–C7; two parts): Part A (first 10 sessions): P2: 30 min. P7: 30 min. Part B (next 10 sessions): P2: 15 min. P7: 45 min. Phase 3 (5 sessions; directing electrode at C6–C7): P7: 45 min. P8: 15 min. Preset programs used and how they differ (this protocol uses four programs): Program 1 (P1): Alternating stimulus times and frequencies ~3.85–7.69 Hz delivered sequentially through the 24 electrodes with multiple pauses; includes polarity alternation. Used at the start of treatment for graded exposure to microcurrents. Program 2 (P2): Frequencies ~1.14–1.96 Hz with input pathways emphasizing distal channels on upper and lower limbs; channel sequencing oriented toward ventral pathways. Program 7 (P7): Alternating stimulus times and frequencies ~1.92–14.29 Hz with symmetric positive/negative pulses and multi-channel sequencing. Program 8 (P8): Sequential stimuli of varying intensity with a stable frequency ~7.69 Hz and symmetric polarity across channels. Note: The device includes additional programs; this trial uses P1, P2, P7, and P8 as specified above. Adherence and fidelity monitoring: - Session attendance log with start/stop times. - Electrode placement checklist (location/integrity/skin prep). - Session record of the selected program(s), order, and exact programmed durations. - Random internal audits of =10% of sessions by a senior investigator. - Documentation of any protocol deviations. Microcurrent parameters: low-frequency microcurrents delivered as bioelectric pulse trains in the ~1–14/15 Hz range, up to ~19,000 pulses/min, as per device specifications.
Sponsors
University of Las Palmas de Gran Canaria
Study design
Allocation
Randomised controlled trial
Intervention model
Parallel
Primary purpose
Treatment
Masking
Blinded (masking used) (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
- Adults aged 18 years or older with a diagnosis of fibromyalgia. - Symptoms present for 6 months or longer. - Functional level greater than 40% (FIQ). - Signed informed consent.
Exclusion criteria
• Pacemaker, internal bleeding, skin lesions at electrode sites • Active inflammatory joint disease, CNS or PNS diseases • Active autoimmune, neoplastic, or infectious diseases • Recent medication changes (<1 month) • No informed consent
Outcome results
None listed