Disclaimer: The content below was generated with the assistance of AI and then reviewed and edited by BrainMaster Technologies, Inc. It is provided for educational and informational purposes only and does not constitute medical advice.
Overview #
This brief research report evaluated the Low Energy Neurofeedback System (LENS) as a potential adjunctive neurotherapy for individuals diagnosed with fibromyalgia (FM). The study used a randomized, double-blind, placebo-controlled design to assess whether LENS could improve clinical symptoms or functional outcomes.
Study Design and Methods #
Participants #
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N = 34 individuals (from an initial 42 randomized) meeting 1990 ACR fibromyalgia criteria completed immediate post-treatment assessments.
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Mean baseline characteristics between groups were comparable, with participants primarily non-Hispanic white women.
Intervention #
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Participants received 22 sessions of either active LENS or sham LENS.
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Active LENS delivered low-intensity electromagnetic pulses linked to the detected EEG peak frequency.
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Sham sessions followed identical procedures, but the active lead was internally severed to prevent EM delivery.
Outcome Measures #
Primary Outcome #
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Fibromyalgia Impact Questionnaire (FIQ) total score
Secondary Outcomes #
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Tender point count and dolorimetry thresholds
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Quantitative Sensory Testing (QST) heat pain threshold
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Self-reported:
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Cognitive dysfunction (POMS-BI-CC)
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Fatigue (BFI)
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Sleep (MOS-Sleep)
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Psychological distress (BSI-GSI)
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Depression (PHQ-9)
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Session-by-session 0–10 symptom ratings (e.g., pain, fatigue, sleep, activity).
Key Findings #
Primary Outcome Results #
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Both active and sham groups improved on FIQ total score immediately post-treatment (p < 0.05).
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No significant differences were found between active and sham groups at post-treatment, 3-month, or 6-month follow-up.
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A temporary divergence appeared at the 3-month mark (sham showing more improvement), but this did not persist.
Secondary Outcomes #
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Both groups showed reductions in tender points, cognitive dysfunction, fatigue, and psychological distress immediately post-treatment (p < 0.05).
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No between-group differences were found at any time point for secondary outcomes.
Session-by-Session Trends #
While group-level outcomes were similar, within-session analysis revealed meaningful linear improvement trends in the active LENS group only, including:
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Decreased pain (p < 0.001)
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Decreased cognitive clouding (p = 0.001)
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Decreased fatigue (p = 0.03)
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Increased activity levels (p = 0.005)
No such trends were observed in the sham group. These effects were not sustained at follow-up.
Interpretation #
Overall Conclusions #
The study concludes that LENS cannot be recommended as a standalone treatment for fibromyalgia based on current evidence. However, within-session improvement trends suggest potential short-term neurophysiological effects that may be promising when paired with multimodal treatment strategies.
Suggested Future Directions #
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Evaluate LENS as part of a combined therapeutic approach (e.g., with physical therapy or surface EMG training).
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Investigate whether LENS may help “prime” or “tone” the nervous system, enhancing responsiveness to other treatment modalities.
Study Limitations #
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Limited demographic diversity (primarily White women).
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Strict inclusion criteria may have created a floor effect on symptom severity.
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Possible unnoticed EM stimulation via reference/ground leads in the sham condition.
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Modest sample size limits statistical power.
