[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100659611":3},{"organization":4,"outcomesModule":7,"designInfo":33,"detailedDescription":43,"studyPopulation":37,"armGroups":44,"interventions":57,"overallOfficials":37,"centralContacts":65,"locations":71,"responsibleParty":90,"collaborators":94,"id":97,"slug":98,"hasResults":99,"nctId":100,"briefTitle":101,"officialTitle":102,"acronym":37,"eligibilityCriteria":103,"healthyVolunteers":99,"sex":104,"minAge":105,"maxAge":106,"enrollmentInfo":107,"targetDuration":37,"studyType":110,"phases":111,"briefSummary":113,"conditions":114,"keywords":116,"overallStatus":118,"whyStopped":37,"lastUpdateSubmitDate":119,"lastUpdatePostDateStruct":120,"startDateStruct":123,"completionDateStruct":125,"leadSponsor":127,"locationsCount":128},{"fullName":5,"class":6},"Jiangxi University of Traditional Chinese Medicine","OTHER",{"primaryOutcomes":8,"secondaryOutcomes":16,"otherOutcomes":20},[9,13],{"measure":10,"description":11,"timeFrame":12},"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.","up to 5 weeks",{"measure":14,"description":15,"timeFrame":12},"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.",[17],{"measure":18,"description":19,"timeFrame":12},"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.",[21,24,27,30],{"measure":22,"description":23,"timeFrame":12},"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.",{"measure":25,"description":26,"timeFrame":12},"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.",{"measure":28,"description":29,"timeFrame":12},"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.",{"measure":31,"description":32,"timeFrame":12},"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\u002Fmoderate\u002Fsevere).",{"allocation":34,"interventionModel":35,"interventionModelDescription":36,"primaryPurpose":6,"observationalModel":37,"timePerspective":37,"maskingInfo":38},"RANDOMIZED","CROSSOVER","Each participant receives both interventions (5 sessions each) in an individually randomized order generated by permuted block randomization (block size = 2); the participant serves as their own control.",null,{"masking":39,"maskingDescription":40,"whoMasked":41},"SINGLE","Practitioners cannot be masked because treatment point selection requires real-time sensitization assessment. Participants remain unaware of their treatment allocation throughout the study. Allocation concealment is achieved through opaque, sealed, sequentially numbered envelopes prepared by a research coordinator not involved in treatment delivery.",[42],"PARTICIPANT","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:\n\n1. Deconstruct: a systematic literature review identified all procedural elements of sensitization acupuncture, catalogued across pre-treatment, intra-treatment, and post-treatment stages.\n2. 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.\n3. 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.\n4. 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.\n5. 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.",[45,51],{"label":46,"type":47,"description":48,"interventionNames":49},"Sensitization Acupuncture","EXPERIMENTAL","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).",[50],"Procedure: Sensitization Acupuncture",{"label":52,"type":53,"description":54,"interventionNames":55},"Traditional Acupuncture","ACTIVE_COMPARATOR","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).",[56],"Procedure: Traditional Acupuncture",[58,62],{"type":59,"name":46,"description":60,"armGroupLabels":61,"otherNames":37},"PROCEDURE","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.",[46],{"type":59,"name":52,"description":63,"armGroupLabels":64,"otherNames":37},"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.",[52],[66],{"name":67,"role":68,"phone":69,"phoneExt":37,"email":70},"Xu Zhou, PhD","CONTACT","18870050733","zhouxu_ebm@hotmail.com",[72],{"facility":73,"status":37,"city":74,"state":75,"zip":76,"country":77,"countryCode":78,"cosmosGeoPoint":79,"geoPoint":84,"contacts":85},"Jiangxi University of Chinese Medicine","Nanchang","Jiangxi","330000","China","CN",{"type":80,"coordinates":81},"Point",[82,83],115.85306,28.68396,{"lat":83,"lon":82},[86],{"name":87,"role":68,"phone":88,"phoneExt":37,"email":89},"Hongmei xu, MSc","18720097459","xuhongmei@jxutcm.edu.cn",{"type":91,"investigatorFullName":92,"investigatorTitle":93,"investigatorAffiliation":5,"oldNameTitle":37,"oldOrganization":37},"PRINCIPAL_INVESTIGATOR","Xu Zhou","Professor",[95],{"name":96,"class":6},"The Affiliated Hospital of Jiangxi University of Traditional Chinese Medicine","100659611","validating-blinding-maintenance-of-a-sham-sensitization-control-design-for-sensitization-acupuncture-trials-100659611",false,"NCT07868224","Validating Blinding Maintenance of a Sham-Sensitization Control Design for Sensitization Acupuncture Trials","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","Inclusion Criteria:\n\n* Aged 18-75 years；\n* Clinically diagnosed with one of the following five conditions: knee osteoarthritis, insomnia, cervical spondylosis, chronic low back pain, or allergic rhinitis\n* Presence of palpable sensitized acupoints\n* Willing to receive sensitization acupuncture treatment\n* Able to understand and communicate sufficiently to complete blinding-assessment questionnaires\n* Willing to participate and provide written informed consent\n\nExclusion Criteria:\n\n* Serious comorbid conditions unrelated to the target disease that could confound assessment (e.g., severe organ failure, malignancy)；\n* Concurrent use of other acupoint-stimulation therapies (e.g., moxibustion, tuina, acupoint injection) whose effects cannot be separated from those of sensitization acupuncture\n* Severe coagulation disorder or local skin infection constituting a contraindication to acupuncture\n* Bleeding disorder or current anticoagulant therapy\n* Pregnant or breastfeeding women\n* Severe fear of needles precluding completion of the standard treatment course\n* Cognitive or communication impairment precluding reliable self-report\n* Currently participating in another sensitization-acupuncture-related clinical trial\n* Unwilling to provide informed consent","ALL","18 Years","75 Years",{"count":108,"type":109},30,"ESTIMATED","INTERVENTIONAL",[112],"NA","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.",[115],"Knee Osteoarthritis; Insomnia; Cervical Spondylosis; Chronic Low Back Pain; Allergic Rhinitis",[117],"acupoint sensitization; sensitization acupuncture; traditional acupuncture; double simulation; blinding; DITTO framework","NOT_YET_RECRUITING","2026-10-05",{"date":121,"type":122},"2026-10-09","ACTUAL",{"date":124,"type":109},"2026-10-10",{"date":126,"type":109},"2026-12-30",{"name":5,"class":6},1]