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.
Authors
- Salvatore Rinaldi (ORCID: https://orcid.org/0000-0002-8961-6316)
- Vania Fontani (ORCID: https://orcid.org/0000-0003-0141-6270)
- Bruna Lombardi
- Arianna Rinaldi
Institutions
- Deutsches Historisches Institut Rom (IT)
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
- Field-Weighted Citation Impact
- 0.00