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.
Aged 18-75 years；
Clinically diagnosed with one of the following five conditions: knee osteoarthritis, insomnia, cervical spondylosis, chronic low back pain, or allergic rhinitis
Presence of palpable sensitized acupoints
Willing to receive sensitization acupuncture treatment
Serious comorbid conditions unrelated to the target disease that could confound assessment (e.g., severe organ failure, malignancy)；
Concurrent use of other acupoint-stimulation therapies (e.g., moxibustion, tuina, acupoint injection) whose effects cannot be separated from those of sensitization acupuncture
Severe coagulation disorder or local skin infection constituting a contraindication to acupuncture
Bleeding disorder or current anticoagulant therapy
Crossover
Sensitization Acupuncture
Procedure/SurgeryGenuine 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
Procedure/SurgeryGenuine 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.
James' Blinding Index
Assessments are conducted after each treatment session, up to Session 10 (scheduled as 2 sessions per week for a total duration of up to 5 weeks). The index is calculated from participants' session-by-session guesses of treatment allocation, pooled across all 10 sessions per participant; reflects overall success of blinding across the trial (range 0-1; 1 indicates perfect blinding, 0.5 indicates guessing consistent with chance). The index computed from the 1st versus the 10th (final) session will additionally be compared as a pre-specified exploratory analysis of whether blinding is maintained as the treatment course progresses.
Bang's Blinding Index
Assessments are conducted after each treatment session, up to Session 10 (scheduled as 2 sessions per week for a total duration of up to 5 weeks). The index is calculated separately for the sensitization-acupuncture arm and the traditional-acupuncture arm from participants' pooled session-by-session guesses; reflects the direction and magnitude of unblinding within each arm (range -1 to 1; 0 indicates blinding consistent with random guessing). The index is compared between the 1st and 10th sessions as a pre-specified exploratory analysis.
Participant's Confidence in Guessed Treatment Allocation
Assessments are conducted after each treatment session, up to Session 10 (scheduled as 2 sessions per week for a total duration of up to 5 weeks).Measured using a 0-10 Numeric Rating Scale (NRS), where 0 indicates the participant's guess was a complete guess with no confidence and 10 indicates the participant was completely certain of the guess. Higher scores indicate greater confidence in the stated guess; this is not a clinical outcome and does not represent a 'better' or 'worse' result.
Acupoint-Specific Deqi Sensation Intensity
Assessments are conducted after each treatment session, up to Session 10 (scheduled as 2 sessions per week for a total duration of up to 5 weeks). Intensity is measured separately for each of the 10 stimulated acupoints per session (5 sensitization points and 5 traditional points) using the Numeric Rating Scale (NRS). The minimum value is 0 (no sensation at all), and the maximum value is 10 (strongest sensation imaginable). Higher scores indicate a more intense sensation (not applicable as a clinically better or worse outcome). Scores from true needling points and sham needling points will be aggregated and compared.
Acupoint-Specific Needling Pain Intensity
Assessments are conducted after each treatment session, up to Session 10 (scheduled as 2 sessions per week for a total duration of up to 5 weeks). Pain intensity is measured separately for each of the 10 stimulated acupoints per session (5 sensitization points and 5 traditional points) using the Numeric Rating Scale (NRS). The minimum value is 0 (no pain at all), and the maximum value is 10 (most severe pain imaginable). Higher scores mean a worse outcome. Scores from true needling points and sham needling points will be aggregated and compared.
Acupoint-Specific Needle-Penetration Perception Intensity
Assessments are conducted after each treatment session, up to Session 10 (scheduled as 2 sessions per week for a total duration of up to 5 weeks). Penetration perception is measured separately for each of the 10 stimulated acupoints per session (5 sensitization points and 5 traditional points) using the Numeric Rating Scale (NRS). The minimum value is 0 (no perceived penetration at all), and the maximum value is 10 (deepest perceived penetration). Higher scores indicate a more intense perceived sensation (not applicable as a clinically better or worse outcome). Scores from true needling points and sham needling points will be aggregated and compared.
Incidence and Severity of Adverse Events
Assessments are conducted after each treatment session, up to Session 10 (scheduled as 2 sessions per week for a total duration of up to 5 weeks).Adverse events will be recorded after every session and compared between sensitization acupuncture and traditional acupuncture by incidence and severity (mild/moderate/severe).
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Jiangxi University of Traditional Chinese Medicine
Lead sponsor
The Affiliated Hospital of Jiangxi University of Traditional Chinese Medicine
Collaborator
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