Rumo zhentong Yin for blood-stasis-type osteoporotic pain: protocol of a randomized, single-blind, controlled trial.

BACKGROUND: Osteoporosis (OP) is a metabolic skeletal disease characterized by reduced bone mass and micro-architectural deterioration, with Osteoporotic pain (OPP) as its most common clinical symptom, which markedly impairs quality of life. Modern pharmacologic treatments' limitations are obvious with population aging, so the cost-effective interventions for OPP are urgently needed. As an empirical formula, Rumo zhentong Yin has been created by the national renowned veteran Traditional Chinese Medicine (TCM) practitioner Yao Shujin for blood-stasis pain. Hence, this trial was designed to investigate the efficacy of Rumo zhentong Yin in treating blood-stasis-type OPP. METHODS: A randomized, single-blind, controlled trial was designed to evaluate the efficacy of Rumo zhentong Yin combined with standard therapy for OPP. Eligible OPP patients were recruited and randomly assigned (1:1) to form either the control or treatment group. Both groups received standard treatment. The intervention lasted 3 months, with follow-up evaluations every 4 weeks. Primary outcome was pain scores; secondary outcomes included bone mineral density (BMD), bone-turnover markers, inflammatory cytokines, blood-stasis syndrome score and hematological indices. ANTICIPATED RESULTS: To our knowledge, this trial is the first clinical study of Rumo zhentong Yin for OPP, with the primary objective to provide robust clinical evidence supporting the integration of Traditional Chinese and Western medicine for OPP. TRIAL REGISTRATION: The trial was registered at the International Traditional Medicine Clinical Trial Registry (www.itmctr.ccebtcm.org.cn) on 2026-01-08 (ITMCTR2026000740).