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

NCT07868224 | Not Yet Recruiting DMC

• 2 other identifiers: JZFYLL2026081220182460993
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

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

Keywords

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

Outcome Measures

Primary Outcomes (2)

• 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

• 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.

  up to 5 weeks

Secondary Outcomes (1)

• Participant's Confidence in Guessed Treatment Allocation

  up to 5 weeks

Other Outcomes (4)

• Acupoint-Specific Deqi Sensation Intensity

  up to 5 weeks

• Acupoint-Specific Needling Pain Intensity

  up to 5 weeks

• Acupoint-Specific Needle-Penetration Perception Intensity

  up to 5 weeks

Study Arms (2)

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).

Procedure: Sensitization Acupuncture

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).

Procedure: Traditional Acupuncture

Interventions

Sensitization Acupuncture 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.

Sensitization Acupuncture

Traditional Acupuncture PROCEDURE

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.

Traditional Acupuncture

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Jiangxi University of Traditional Chinese Medicine: lead
• The Affiliated Hospital of Jiangxi University of Traditional Chinese Medicine: collaborator

Study Sites (1)

Jiangxi University of Chinese Medicine

Nanchang, Jiangxi, 330000, China

Location

MeSH Terms

Conditions

Osteoarthritis, Knee; Sleep Initiation and Maintenance Disorders; Spondylosis; Rhinitis, Allergic

Condition Hierarchy (Ancestors)

Osteoarthritis; Arthritis; Joint Diseases; Musculoskeletal Diseases; Rheumatic Diseases; Sleep Disorders, Intrinsic; Dyssomnias; Sleep Wake Disorders; Nervous System Diseases; Mental Disorders; Spinal Diseases; Bone Diseases; Rhinitis; Nose Diseases; Respiratory Tract Diseases; Respiratory Hypersensitivity; Otorhinolaryngologic Diseases; Hypersensitivity, Immediate; Hypersensitivity; Immune System Diseases

Central Study Contacts

Xu Zhou, PhD

CONTACT

18870050733; zhouxu_ebm@hotmail.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Masking Details: 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.
• Purpose: OTHER
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Model Details: 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.

Study Record Dates

• First Submitted: September 27, 2026
• First Posted: October 9, 2026
• Study Start: October 10, 2026
• Primary Completion (Estimated): December 1, 2026
• Study Completion (Estimated): December 30, 2026
• Last Updated: October 9, 2026

Record last verified: 2026-10

Locations

CN (1)