An interventional study of Sensitization Acupuncture and Traditional Acupuncture in Knee Osteoarthritis; Insomnia; Cervical Spondylosis; Chronic Low Back Pain; Allergic Rhinitis, sponsored by Jiangxi University of Traditional Chinese Medicine. Not yet recruiting at 1 site in China. Open to participants aged 18 Years to 75 Years. Per ClinicalTrials.gov, last updated 2026-10-09.
Sponsored by Jiangxi University of Traditional Chinese Medicine · Not applicable, Interventional, and Other
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:
3,391 studies on the registry are indexed under Osteoarthritis, Knee; 628 are open to participants now.
This study's planned enrollment of 30 is below the median of 69 across 2,808 interventional studies indexed under Osteoarthritis, Knee.
Browse Osteoarthritis, Knee studies →Jiangxi University of Traditional Chinese Medicine is the lead sponsor of 15 studies on the registry; 8 are open to participants now.
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Exclusion Criteria:
All participants receive this treatment in 5 of their 10 total sessions, interspersed in an individually randomized order with the traditional acupuncture treatment (crossover design).
Procedure: Sensitization Acupuncture
All participants receive this treatment in 5 of their 10 total sessions, interspersed in an individually randomized order with the sensitization acupuncture treatment (crossover design).
Procedure: Traditional 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.
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.
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.
Time frame: up to 5 weeks
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.
Time frame: up to 5 weeks
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.
Time frame: up to 5 weeks
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.
Time frame: up to 5 weeks
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.
Time frame: up to 5 weeks
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.
Time frame: up to 5 weeks
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).
Time frame: up to 5 weeks
Plan to share: Undecided — Individual participant data will not be shared. Given the small pilot sample size (n=30), de-identified data may still carry a risk of re-identification. In addition, the study team has not established a formal data-sharing infrastructure or repository at this stage.
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From the registry record's own update history. This site started tracking changes on Sep 25, 2026; for anything earlier, see the record history on ClinicalTrials.gov ↗
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Jiangxi University of Traditional Chinese Medicine