Clinical Performance of REAC-Based ACT, CO, and MO-IBZ Protocols in Routine Practice: A Prospective Real-World Observational PMCF Study

<b>Background/Objectives:</b> Chronic low-grade inflammation underlies persistent pain, sleep disturbance, fatigue, and reduced perceived well-being. ACT (anti-inflammatory cellular treatment), CO (circulatory optimization), and MO (metabolic optimization) are non-invasive REAC-based biomodulation protocols within the Inside Blue Zone (IBZ) framework, yet real-world evidence on patient-reported outcomes remains limited. The aim of this study was to evaluate pain intensity and symptom burden (sleep disturbance, fatigue, perceived well-being) in subjects undergoing ACT, CO, and MO within a Post-Market Clinical Follow-Up (PMCF) framework. <b>Methods:</b> This prospective observational PMCF study enrolled 50 subjects receiving sequential ACT, CO, and MO in routine practice. Pain was assessed at baseline (T0), end of treatment (T1), and follow-up (T2) using a Visual Analog Scale (VAS). Secondary outcomes were analyzed through clinically meaningful severity categories. <b>Results:</b> VAS scores decreased significantly from T0 to T1 (t(49) = 21.37, <i>p</i> < 0.001, Cohen's d = 3.02) and remained reduced at T2. Seventy-eight percent met responder criteria. Secondary outcomes shifted toward lower severity categories at both timepoints. No adverse events occurred. <b>Conclusions:</b> Sequential ACT, CO, and MO produced clinically meaningful pain reductions and favorable symptom severity shifts with good tolerability, supporting clinical performance of this REAC-based approach in chronic low-grade inflammatory conditions.

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Publication Details

Journal
Journal of Clinical Medicine
Published
2026-03-07
DOI
https://doi.org/10.3390/jcm15052048
Primary Topic
Chronic Obstructive Pulmonary Disease (COPD) Research
Type
article
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article

Clinical Performance of REAC-Based ACT, CO, and MO-IBZ Protocols in Routine Practice: A Prospective Real-World Observational PMCF Study

Salvatore Rinaldi, Vania Fontani, Bruna Lombardi, Arianna Rinaldi
Journal of Clinical Medicine
Chronic Obstructive Pulmonary Disease (COPD) Research
article

Clinical Performance of REAC-Based ACT, CO, and MO-IBZ Protocols in Routine Practice: A Prospective Real-World Observational PMCF Study

Salvatore Rinaldi, Vania Fontani, Bruna Lombardi, Arianna Rinaldi
article en

Abstract

<b>Background/Objectives:</b> Chronic low-grade inflammation underlies persistent pain, sleep disturbance, fatigue, and reduced perceived well-being. ACT (anti-inflammatory cellular treatment), CO (circulatory optimization), and MO (metabolic optimization) are non-invasive REAC-based biomodulation protocols within the Inside Blue Zone (IBZ) framework, yet real-world evidence on patient-reported outcomes remains limited. The aim of this study was to evaluate pain intensity and symptom burden (sleep disturbance, fatigue, perceived well-being) in subjects undergoing ACT, CO, and MO within a Post-Market Clinical Follow-Up (PMCF) framework. <b>Methods:</b> This prospective observational PMCF study enrolled 50 subjects receiving sequential ACT, CO, and MO in routine practice. Pain was assessed at baseline (T0), end of treatment (T1), and follow-up (T2) using a Visual Analog Scale (VAS). Secondary outcomes were analyzed through clinically meaningful severity categories. <b>Results:</b> VAS scores decreased significantly from T0 to T1 (t(49) = 21.37, <i>p</i> < 0.001, Cohen's d = 3.02) and remained reduced at T2. Seventy-eight percent met responder criteria. Secondary outcomes shifted toward lower severity categories at both timepoints. No adverse events occurred. <b>Conclusions:</b> Sequential ACT, CO, and MO produced clinically meaningful pain reductions and favorable symptom severity shifts with good tolerability, supporting clinical performance of this REAC-based approach in chronic low-grade inflammatory conditions.

Journal of Clinical MedicineVol. 15(5)
Deutsches Historisches Institut Rom (IT)
Good health and well-being
Openalex Percentile: Top 29%
Chronic Obstructive Pulmonary Disease (COPD) Research
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