Background: Chemotherapy-induced peripheral neuropathy (CIPN) is one of the most common side effects of chemotherapy, and effective treatments for CIPN are still lacking. For this reason, there is a growing interest in complementary and alternative medicine as a potential source of nonsurgical treatments for CIPN symptoms alongside pregabalin. One such option being explored is Chuna manual therapy (CMT), a traditional Korean manual therapy. Methods: This study compares the effectiveness and safety of using only pregabalin (PG) as a conventional method of treating breast and colorectal cancer patients with CIPN symptoms with a combination of both PG and electroacupuncture (EA) or CMT, while also assessing the feasibility of future large-scale clinical studies. Due to the COVID-19 pandemic, only 74 CIPN patients were recruited to this study. Twenty-five were assigned to the PG group, 26 to the PG + EA group, and 22 to the PG + CMT group for a five-week treatment and a four-week follow-up study. Results: For the primary outcome, we evaluated the mean differences in Functional Assessment of Cancer Therapy/Gynecologic Oncology Group-Neurotoxicity (FACT/GOG-Ntx) compared to the baseline at week 5 (visit 4). Although we found that the PG + CMT group showed the biggest difference (−16.64 [95% CI: −25.16, −8.11]) compared to the PG group (−8.60 [95% CI: −14.93, −2.27]) and the PG + EA group (−6.73 [95% CI: −12.34, −1.13]), this finding lacked statistical significance (p = 0.2075). In terms of safety, two patients in the PG + CMT group reported side effects: one bruise and one headache. Conclusions: The low attrition and high adherence rates of all the groups, and the similar rates of side effects among them, support the feasibility of larger-scale follow-up studies.
Background/Objectives: We aimed to explore whether selected non-invasive three-dimensional (3D) body surface indicators differed between prospectively defined enrollment groups and, in linked post-hoc analyses, to identify candidate indicators associated with expert manual judgment. Methods: At screening (visit 1), 88 participants underwent manual examination and pelvic X-ray assessment. Of these, 60 entered the prospective pilot study and underwent 3D body surface analysis at visit 2. The prespecified prospective comparison used the protocol-defined malalignment group (n = 30) and comparison group (n = 30). Final manual diagnosis served as an expert-judgment reference comparator. For post-hoc exploratory ROC analyses, the same 60 participants were reclassified according to final manual diagnosis alone as manual-positive (n = 40) or manual-negative (n = 20). Results: In the prespecified prospective comparison, neither 3D surface-height asymmetry nor marker-angle outcomes differed significantly between the protocol-defined enrollment groups across postures P1–P4. Among all 88 screened participants, X-ray sensitivity and specificity relative to final manual diagnosis were 88.6% and 34.1%, respectively. In the post-hoc exploratory ROC analyses, IC surface-height difference at P3 showed an apparent AUC of 0.684 (p = 0.015), and the highest individual marker-angle AUC was 0.706 at P2 (p = 0.005). An exploratory five-variable model, developed and evaluated in the same dataset, yielded an apparent in-sample AUC of 0.756. Conclusions: The prespecified 3D comparisons did not distinguish the protocol-defined enrollment groups. Post-hoc analyses of the same 60 participants identified candidate 3D indicators associated with expert manual judgment, but these findings were exploratory and do not establish diagnostic accuracy or clinical utility. Prospective validation using prespecified indicators and thresholds, an appropriate independent or composite reference standard, and formal reliability assessment is required before a clinical role for 3D body surface analysis can be determined.
Background/Objectives: Low-back pain (LBP) is a common musculoskeletal disorder, with a lifetime prevalence reported to be as high as 84%. Chuna manipulative therapy (CMT), a Korean style of manual therapy for correcting joint misalignment, has rarely been evaluated in randomized controlled trials (RCTs). This study primarily aimed to evaluate the feasibility of a future large-scale, multicenter RCT comparing thrust and non-thrust CMT; preliminary clinical and safety data were collected as secondary, exploratory objectives. Methods: This multicenter, assessor-blinded pilot RCT randomized 30 participants with non-acute LBP and pelvic deviation into thrust (n = 15) or non-thrust (n = 15) CMT groups for a 4-week treatment. Feasibility outcomes (eligibility, recruitment, adherence, retention, data completeness, and treatment fidelity) were the primary endpoints. Preliminary clinical effects (Numeric Rating Scale (NRS), Oswestry Disability Index (ODI)) and adverse events were assessed over 24 weeks as exploratory outcomes. Results: Of the 35 screened, 30 (85.7%) were randomized, and the planned 15 per center was achieved at both sites. Twenty-nine (96.7%) received at least the minimum number of sessions and were retained to week 24, with complete outcome data and no protocol deviations in intervention delivery. In exploratory analyses, both groups improved from baseline and between-group differences favored thrust CMT, but as the trial was not powered to compare effectiveness, these findings are preliminary only. Nine mild adverse events resolved spontaneously. Conclusions: A large-scale, multicenter RCT comparing thrust and non-thrust CMT in pelvic deviation is feasible. The observed feasibility outcomes can inform its progression criteria, whereas the exploratory clinical findings require confirmation in an adequately powered definitive trial.