Validating Blinding Maintenance of a Sham-Sensitization Control Design for Sensitization Acupuncture Trials

Knee Osteoarthritis; Insomnia; Cervical Spondylosis; Chronic Low Back Pain; Allergic Rhinitis

acupoint sensitization; sensitization acupuncture; traditional acupuncture; double simulation; blinding; DITTO framework

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.

The sham-sensitization control design validated in this study is one component of a larger research program to develop a randomized controlled trial comparing sensitization acupuncture with traditional acupuncture. The control design was developed through a five-step process based on the DITTO framework, originally proposed by the UK National Institute for Health Research (NIHR) for surgical placebo interventions: 1. Deconstruct: a systematic literature review identified all procedural elements of sensitization acupuncture, catalogued across pre-treatment, intra-treatment, and post-treatment stages. 2. Identify: semi-structured interviews with five acupuncture experts and five patient representatives identified 25 key elements whose between-group differences could plausibly cause unblinding or contribute to therapeutic effect. 3. Take out: for each of the 25 key elements, the corresponding operation was first fully replicated from the sensitization acupuncture group into the traditional acupuncture group to eliminate procedural differences between groups. Each replicated element was then evaluated for potential additional therapeutic effect in the traditional acupuncture group. For the 4 elements judged relevant to therapeutic effect, a dedicated take-out plan was developed to remove or minimize effect-producing content while preserving blinding, and a bidirectional double-simulation was applied: in sensitization acupuncture, the preset traditional acupoints receive shallow or non-penetrating needling; in traditional acupuncture, the identified sensitized acupoints receive shallow or non-penetrating needling. Points receiving simulated needling are located 10-20 mm lateral to the corresponding genuine acupoint to remove therapeutic effect. The remaining 21 elements, judged unrelated to therapeutic effect, were fully replicated (simulated) without further modification. 4. Think: an expert panel is evaluating the preliminary plan. The 4 elements requiring a take-out plan and double-simulation are being rated on four dimensions：blinding maintenance, residual therapeutic effect, risk of bias, and feasibility. The remaining 21 fully-simulated elements are being rated on three dimensions：therapeutic inertia (absence of a meaningful residual effect), risk of bias, and feasibility, since full simulation between groups is considered to inherently preserve blinding. Results will be used to finalize the draft technical guideline. 5. Optimize (the present study):Three or five physicians experienced in sensitization acupuncture will pilot-test the draft guideline in 30 participants using a randomized crossover design (5 sensitization acupuncture and 5 traditional acupuncture sessions per participant, sequence generated by permuted block randomization). After each session, participants guess which treatment they received, state their reasons, and rate their confidence (0-10); James' and Bang's Blinding Indices are calculated from these guesses pooled by treatment type, and indices from the 1st versus the 10th session are compared as a pre-specified exploratory analysis. Deqi, pain, and needle-penetration perception ratings and adverse events are compared between the two treatments. Findings will inform refinement of the technical guideline before its use in the definitive RCT.

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