Validating Blinding Maintenance of a Sham-Sensitization Control Design for Sensitization Acupuncture Trials
Not yet recruitingNot applicableNCT07868224
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This study has no listed site in Canada in this snapshot. It is included as part of the worldwide chronic pain corpus.
Brief summary (from the registry)
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.
Study details
- 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
- Conditions
- Knee Osteoarthritis
- Insomnia
- Cervical Spondylosis
- Chronic Low Back Pain
- Allergic Rhinitis
- Interventions
- Procedure: Sensitization Acupuncture
- Procedure: Traditional Acupuncture
- Sponsor
- Jiangxi University of Traditional Chinese Medicine
- Collaborators
- The Affiliated Hospital of Jiangxi University of Traditional Chinese Medicine
- Start date
- 2026-10-10
- Primary completion
- 2026-12-01
- Sex
- All
- Age range
- from 18 Years to 75 Years
- Results posted
- No results posted in this snapshot
- Countries
- China
- Total sites listed
- 1
Eligibility criteria
Show eligibility criteria (verbatim from the registry)
Inclusion Criteria: * 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 * Able to understand and communicate sufficiently to complete blinding-assessment questionnaires * Willing to participate and provide written informed consent Exclusion Criteria: * 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 * Pregnant or breastfeeding women * Severe fear of needles precluding completion of the standard treatment course * Cognitive or communication impairment precluding reliable self-report * Currently participating in another sensitization-acupuncture-related clinical trial * Unwilling to provide informed consent
Source: ClinicalTrials.gov (US National Library of Medicine), snapshot October 2026. Check the registry for current recruiting status. Record: https://clinicaltrials.gov/study/NCT07868224