Evaluating Traditional Bonesetting Interventions: A Methodological Review and Framework for Clinical Research.

Traditional bonesetting (TBS) remains an important source of fracture care in many low- and middle-income settings. Still, its evidence base is difficult to interpret because care pathways are heterogeneous, practitioner-dependent, and often incompletely specified. This methodological review synthesizes recurring design and reporting problems in TBS research and translates established complex-intervention principles into a practical framework. PubMed was the principal biomedical source, supplemented by Google Scholar, citation chaining, and targeted searches of methodological and implementation literature; the literature update extended through August 31, 2026. Major threats to interpretation include exposure misclassification, poorly described provider expertise and comparators, confounding by indication, absent pretreatment outcomes, inconsistent follow-up, passive harm ascertainment, and limited fidelity assessment. Recent observational evidence linking specific immobilization and topical practices to serious outcomes, along with training and collaborative-care studies, reinforces the need to evaluate components and care pathways rather than the TBS label alone. We propose the TBS-8 Framework: intervention specification; provider characterization, training, and expertise; comparator definition; baseline prognostic measurement; allocation and confounding control; outcome and follow-up architecture; active safety surveillance; and process evaluation. Randomized and pragmatic designs are appropriate only when genuine clinical equipoise exists and randomization is ethical and feasible; prospective comparative cohorts can be informative when preference, access, or safety considerations limit randomization. The TBS-8 Framework is conceptual and unvalidated. Its purpose is to translate established methodological principles and recurrent TBS-specific problems into eight proposed core domains for reproducible, measurable, and safety-conscious comparative-effectiveness and implementation research.