Effect of integrated visceral and spinal manipulation on abdominal pain, severity of dyspepsia, psychological status, sleep disorder, and quality of life among adult patients with functional dyspepsia: a single blind randomized controlled trial

Functional Dyspepsia (FD) is a highly prevalent functional gastrointestinal disorder associated with significant physical symptoms, psychological distress, and impaired quality of life. Current treatments often fail to address the underlying neuro-visceral pathophysiology. This study aimed to compare the therapeutic efficacy of Integrated Visceral and Spinal Manipulation (InViSMa) against an active control intervention (InASMa) in adult FD patients. The study assessed the differential effects of InViSMa on abdominal pain, dyspepsia severity, psychological status, sleep quality, and health-related quality of life. A prospective, single-blind Randomized Controlled Trial (RCT) was conducted involving 56 adult FD patients who completed the study protocol (InViSMa, n=29; Control, n=27). Participants in both groups received 12 treatment sessions over a four-week intervention period, followed by a one-week post-treatment follow-up. Primary and secondary outcomes were measured using the Abdominal Pain Index (API), Leeds Dyspepsia Questionnaire (LDQ), Perceived Stress Scale (PSS), Pittsburgh Sleep Quality Index (PSQI), and Nepean Dyspepsia Index (NDI). Data were analyzed using non-parametric tests, with the Mann-Whitney U test employed for between-group comparisons. The InViSMa protocol demonstrated highly significant and superior therapeutic efficacy compared to the control group across all measured outcomes. Primary Outcomes: At the follow-up assessment (Week 5), the InViSMa group achieved a statistically superior and clinically relevant reduction in both dyspepsia severity (LDQ) and abdominal pain (API) compared to the control group (all p < 0.001), with large effect sizes (r = 0.52). The control intervention failed to produce a significant reduction in LDQ scores throughout the trial. Secondary Outcomes: InViSMa was also significantly superior in improving psychological status (PSS), sleep quality (PSQI), and quality of life (NDI) across all subscales, with sustained improvements noted at follow-up (all between-group p < 0.001). The control group showed no significant change in any of these systemic secondary outcomes. Integrated Visceral and Spinal Manipulation (InViSMa) is a highly effective and evidence-based non-pharmacological treatment for Functional Dyspepsia. The therapeutic superiority of InViSMa suggests that the synergistic correction of both visceral restriction and spinal facilitation is necessary to normalize Autonomic Nervous System function, resulting in comprehensive and sustained symptomatic and systemic relief. This integrated approach warrants inclusion in the clinical guidelines for FD management.