Clinical Scorecard: Impact of the EXOPULSE Mollii Suit on Fibromyalgia Patients: Results from a Double-Blind, Randomized Sham-Controlled Study (EXOFIB2)
At a Glance
Category
Detail
Condition
Fibromyalgia
Key Mechanisms
Neuromodulation via transcutaneous electrical stimulation targeting widespread pain through full-body electrode coverage
Target Population
Adults aged 18-75 years with fibromyalgia diagnosed by ACR 2010 criteria
Care Setting
Hospital outpatient clinics (rheumatology, pain management, neurology) and home-based therapy
Key Highlights
EXOPULSE Mollii Suit delivers low-frequency transcutaneous electrical stimulation via 58 electrodes covering up to 40 muscle groups.
Two weeks of daily 1-hour active stimulation significantly reduced fibromyalgia impact (FIQtotal) and improved pain catastrophizing and quality of life compared to sham.
Four-week open-label extension showed sustained benefits including reductions in depression and anxiety without severe adverse events.
Guideline-Based Recommendations
Diagnosis
Fibromyalgia diagnosis based on American College of Rheumatology (ACR) 2010 criteria with symptoms persisting at least 3 months.
Management
Consider neuromodulation using EXOPULSE Mollii Suit as a non-pharmacological adjunct for fibromyalgia patients with moderate to severe pain (VAS ≥4).
Daily 1-hour sessions over multiple weeks may provide clinically meaningful improvements in disease impact and related symptoms.
Monitoring & Follow-up
Monitor fibromyalgia impact using Fibromyalgia Impact Questionnaire (FIQtotal) and assess secondary outcomes including pain, anxiety, depression, and quality of life.
Observe for adverse events; no severe adverse events reported in study.
Risks
Contraindications include presence of cardiac stimulators, ventriculoperitoneal shunts, intrathecal baclofen pumps, pregnancy, recent changes in pharmacological therapy, BMI >35 kg/m2, and other somatic or psychiatric comorbidities beyond anxiety and depression.
Patient & Prescribing Data
Adult fibromyalgia patients with moderate to severe pain, stable pharmacological treatment, and no contraindications to electrical stimulation.
Repeated daily stimulation sessions with the EXOPULSE Mollii Suit over 2 to 4 weeks can reduce fibromyalgia impact and improve associated symptoms with good tolerability.
Clinical Best Practices
Ensure patient eligibility by confirming diagnosis and absence of contraindications before initiating EXOPULSE Mollii Suit therapy.
Use a double-blind, sham-controlled approach when possible to assess individual response to treatment.
Incorporate patient-reported outcome measures such as FIQtotal and pain catastrophizing scales to monitor treatment efficacy.
Educate patients on the home-based use of the EXOPULSE Mollii Suit to promote adherence and sustained benefits.
Plan for follow-up assessments to evaluate long-term effects and adjust therapy accordingly.
