Currently submitted to: JMIR Research Protocols
Date Submitted: Feb 12, 2026
Open Peer Review Period: Feb 12, 2026 - Apr 9, 2026
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Clinical Efficacy of Zhang’s Formula No. 2 Fumigation Combined with Blood Flow Restriction Training in Middle-Aged and Elderly Patients with Early-Stage Knee Osteoarthritis and Liver-Kidney Deficiency:A Randomized Controlled Trial Protocol
ABSTRACT
Background:
Knee osteoarthritis (KOA) is a prevalent degenerative joint disorder that causes chronic pain and functional impairment, particularly among middle-aged and older adults. In early-stage KOA, patients often exhibit reduced periarticular muscle strength and compromised joint function. Without timely intervention, the condition may progress to irreversible structural damage. In Traditional Chinese Medicine (TCM), this stage frequently corresponds to the Liver-Kidney Deficiency pattern, characterized by insufficient nourishment of tendons and bones and diminished muscular function—representing a critical window for therapeutic intervention. Herbal fumigation and Blood Flow Restriction Training (BFRT) each offer advantages in improving local circulation and enhancing muscle strength, respectively; however, clinical evidence for their combined application remains insufficient.
Objective:
This study aims to systematically evaluate the clinical efficacy and safety of Zhang’s Formula No. 2 fumigation combined with BFRT in middle-aged and elderly patients diagnosed with early-stage KOA and TCM-defined Liver-Kidney Deficiency syndrome.
Methods:
This is a prospective, single-center, randomized, single-blind, four-arm, parallel-group controlled clinical trial. A total of 140 patients with KOA meeting both the Kellgren-Lawrence grade I–II radiographic criteria and the TCM diagnostic criteria for Liver-Kidney Deficiency syndrome (as outlined in the Guiding Principles for Clinical Research on New Chinese Medicines) will be enrolled. Participants will be randomly assigned in a 1:1:1:1 ratio to one of four groups:Control group (usual care), Fumigation group, BFRT group, or Combined intervention group. The intervention period will last 8 weeks, with follow-up assessments conducted at week 12. The primary outcome is the total score of the Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC). Secondary outcomes include: pain intensity measured by the Visual Analogue Scale (VAS), TCM syndrome severity score, the 36-Item Short Form Health Survey (SF-36), knee extensor muscle strength, and the Clinical Global Impression of Change (CGI-C). All outcomes will be assessed by blinded evaluators at baseline (week 0) and at weeks 4, 8, and 12.
Results:
Participant recruitment is scheduled to begin in January 2026, with enrollment and interventions expected to be completed by June 2027. Data collection will conclude by October 2027, and primary statistical analysis and manuscript preparation are anticipated in early 2028.
Conclusions:
Through a rigorously designed randomized controlled trial, this study will investigate the feasibility, efficacy, and safety of an integrative intervention combining TCM external therapy (herbal fumigation) with modern low-load resistance training (BFRT) in patients with early-stage KOA and Liver-Kidney Deficiency. The findings are expected to inform clinical practice and support further research into non-pharmacological, multimodal strategies for managing early KOA within an integrative medicine framework. Clinical Trial: International Traditional Medicine Clinical Trial Registry (ChiCTR), Registration Number: ChiCTR2200066875. Date Registered: December 15, 2025. https://itmctr.ccebtcm.org.cn/
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