Knee Osteoarthritis; Insomnia; Cervical Spondylosis; Chronic Low Back Pain; Allergic RhinitisNCT07868224
Validating Blinding Maintenance of a Sham-Sensitization Control Design for Sensitization Acupuncture Trials
A study testing Sensitization Acupuncture and Traditional Acupuncture in people with Knee Osteoarthritis; Insomnia; Cervical Spondylosis; Chronic Low Back Pain; Allergic Rhinitis, run by Jiangxi University of Traditional Chinese Medicine at 1 site in China.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Knee Osteoarthritis; Insomnia; Cervical Spondylosis; Chronic Low Back Pain; Allergic Rhinitis
- What is being tested?
- Sensitization Acupuncture and Traditional Acupuncture
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 1 siteChina
- Study dates
- 10 Oct 2026to 30 Dec 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Show all 9Show fewer
- Cognitive or communication impairment precluding reliable self-report
- Currently participating in another sensitization-acupuncture-related clinical trial
- Unwilling to provide informed consent
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
China1 site
Jiangxi University of Chinese Medicine
Nanchang, Jiangxi, 330000
Hongmei xu, MSc, 18720097459, xuhongmei@jxutcm.edu.cn
About this study
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
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.
Read the detailed description
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:
- Deconstruct: a systematic literature review identified all procedural elements of sensitization acupuncture, catalogued across pre-treatment, intra-treatment, and post-treatment stages.
- 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.
- 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.
- 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.
- 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.
- Conditions
- Knee Osteoarthritis; Insomnia; Cervical Spondylosis; Chronic Low Back Pain; Allergic Rhinitis
- Being tested
- Sensitization Acupuncture, Traditional Acupuncture
- Keywords
- acupoint sensitization; sensitization acupuncture; traditional acupuncture; double simulation; blinding; DITTO framework
- Medical subject headings
- Osteoarthritis, Knee, Sleep Initiation and Maintenance Disorders, Spondylosis, Rhinitis, Allergic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Sensitization AcupunctureProcedure or surgery
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.
Traditional AcupunctureProcedure or surgery
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.
| Study group | Role | What they receive |
|---|---|---|
| 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). Receives: 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). Receives: Procedure: Traditional Acupuncture |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: up to 5 weeks
Secondary outcomes (1)
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.
Measured: up to 5 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Oct 2026
- Study start10 Oct 2026 (estimated)
- Primary completion1 Dec 2026 (estimated)
- Study completion30 Dec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Knee Osteoarthritis; Insomnia; Cervical Spondylosis; Chronic Low Back Pain; Allergic RhinitisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Crossover
- Model description
- 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.
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 30 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Jiangxi University of Traditional Chinese Medicine
- Sponsor type
- University, hospital or other
- Collaborators
- The Affiliated Hospital of Jiangxi University of Traditional Chinese Medicine
- Responsible party
- Principal investigator, Xu Zhou, Jiangxi University of Traditional Chinese Medicine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07868224
- Sponsor's protocol ID
- JZFYLL20260812201
- Other IDs
- 82460993
- Status last verified
- Oct 2026
- First submitted
- 27 Sep 2026
- Last updated
- 9 Oct 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- 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.
Study at a glance
From the registry record, last updated by the sponsor on 9 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT07868224
- Acronym / sponsor ID
- JZFYLL20260812201
- Conditions
- Knee Osteoarthritis; Insomnia; Cervical Spondylosis; Chronic Low Back Pain; Allergic Rhinitis
- Keywords
- acupoint sensitization; sensitization acupuncture; traditional acupuncture; double simulation; blinding; DITTO framework
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- Jiangxi University of Traditional Chinese MedicineUniversity, hospital or other
- Collaborators
- The Affiliated Hospital of Jiangxi University of Traditional Chinese Medicine
- Study start
- 10 Oct 2026 (estimated)
- Primary completion
- 1 Dec 2026 (estimated)
- Study completion
- 30 Dec 2026 (estimated)
- First posted
- 9 Oct 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
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:
- Deconstruct: a systematic literature review identified all procedural elements of sensitization acupuncture, catalogued across pre-treatment, intra-treatment, and post-treatment stages.
- 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.
- 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.
- 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.
- 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.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Single blind (participant)
- Number of arms
- 2
- Model description
- 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.
| Arm | Type | Receives |
|---|---|---|
| Sensitization Acupuncture | Experimental | Procedure: Sensitization AcupunctureAll participants receive this treatment in 5 of their 10 total sessions, interspersed in an individually randomized order with the traditional acupuncture treatment (crossover design). |
| Traditional Acupuncture | Active comparator | Procedure: Traditional AcupunctureAll participants receive this treatment in 5 of their 10 total sessions, interspersed in an individually randomized order with the sensitization acupuncture treatment (crossover design). |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- 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
Key exclusion criteria (9 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Sensitization AcupunctureGenuine 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. | Procedure or surgery | Sensitization Acupuncture |
| Traditional AcupunctureGenuine 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. | Procedure or surgery | Traditional Acupuncture |
Primary outcome
James' Blinding Index
Time frame: up to 5 weeks
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
Time frame: up to 5 weeks
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.
1 secondary outcome
Participant's Confidence in Guessed Treatment Allocation
Time frame: up to 5 weeks
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Oct 2026.
- Individual participant dataSharing planned: 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.
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Sensitization Acupuncture and Traditional Acupuncture in people with Knee Osteoarthritis; Insomnia; Cervical Spondylosis; Chronic Low Back Pain; Allergic Rhinitis, run by Jiangxi University of Traditional Chinese Medicine at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 9 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Xu Zhou, PhD (18870050733, zhouxu_ebm@hotmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
James' Blinding Index (time frame: up to 5 weeks). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 9 Oct 2026.