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Validating Blinding Maintenance of a Sham-Sensitization Control Design for Sensitization Acupuncture Trials
Sponsor: Jiangxi University of Traditional Chinese Medicine
Summary
This study is the clinical validation component of a broader research program developing a randomized controlled trial (RCT) comparing sensitization acupuncture (an individualized technique in which treatment points are selected by palpation for sensitized acupoints) with traditional acupuncture (a technique using preset, fixed acupoints). To keep participants unaware of which treatment they receive, the program constructed a control design using a structured five-step framework (Deconstruct-Identify-Take out-Think-Optimize, DITTO), in which each treatment incorporates a double-simulation: in sensitization acupuncture, sensitized acupoints are needled genuinely while the preset traditional acupoints receive shallow or non-penetrating needling; in traditional acupuncture, the preset acupoints are needled genuinely while the identified sensitized acupoints receive shallow or non-penetrating needling. This study validates whether this design maintains participant blinding in practice. Thirty participants with one of five conditions (knee osteoarthritis, insomnia, cervical spondylosis, chronic low back pain, or allergic rhinitis) will each receive 10 sessions in a randomized order: 5 sessions of sensitization acupuncture and 5 sessions of traditional acupuncture. After each session, participants will guess which treatment they received, state their reasons, and rate their confidence; blinding will be evaluated using James' and Bang's Blinding Indices. Sensory experience (deqi, pain, needle-penetration perception) and adverse events will also be compared between the two treatments. Results will guide refinement of the control design before its use in the definitive RCT.
Official title: Clinical Validation of Blinding Maintenance for a DITTO Framework-Based Sham-Sensitization Control Design in a Randomized Controlled Trial of Sensitization Acupuncture Versus Traditional Acupuncture: A Randomized, Single-Blind, Crossover Trial
Key Details
Gender
All
Age Range
18 Years - 75 Years
Study Type
INTERVENTIONAL
Enrollment
30
Start Date
2026-10-10
Completion Date
2026-12-30
Last Updated
2026-10-09
Healthy Volunteers
No
Conditions
Interventions
Sensitization Acupuncture
Genuine needling (needle insertion, deqi elicitation, and reinforcing-reducing manipulation) at sensitized acupoints identified by palpation. As a double-simulation, the preset traditional acupoints receive shallow or non-penetrating needling at points 10-20 mm lateral to the genuine acupoint, without deqi or manipulation.
Traditional Acupuncture
Genuine needling (needle insertion, deqi elicitation, and reinforcing-reducing manipulation) at preset fixed acupoints. As a double-simulation, the sensitized acupoints identified by palpation receive shallow or non-penetrating needling at points 10-20 mm lateral to the genuine acupoint, without deqi or manipulation.
Locations (1)
Jiangxi University of Chinese Medicine
Nanchang, Jiangxi, China