Tic DisordersATPTDNCT07071428
Acupuncture Treatment in Pediatric Patients With Tic Disorders: A Prospective, Single-Center, Randomized Controlled Trial
A study testing Regular acupuncture and the Nourishing the vital energyand Regulating the spirit needle technique in people with Tic Disorders, run by The Third Affiliated hospital of Zhejiang Chinese Medical University at 1 site in China.
Trial summary
This study was conducted to observe the efficacy of Nourishing the vital energy and Regulating the spirit needle technique in the treatment of chronic tic disorder through the Yale Global Tic Severity Scale (YGTSS) and the Chinese Medicine Symptom Rating Scale in order to provide a new, safe and feasible treatment… Read more about this study
- Who is it for?
- Ages 5 to 18 years
- Conditions the study is for
- Tic Disorders
- What is being tested?
- Regular acupuncture and the Nourishing the vital energyand Regulating the spirit needle technique
- Type of treatment
- Injection or infusion, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 76 participants
- Where
- 1 siteChina
- Study dates
- 1 Aug 2021to 1 Dec 2022
- Phase
- Interventional
- Are there results?
- None posted in the registry
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 5 to 18 years
- All sexes
- No healthy volunteers
- Child, Adult
Who may be able to join
- Patients diagnosed with tic disorders per the Diagnostic and Statistical Manual of Mental Disorders, version 5 (DSM-5) criteria Presence of either motor tics or vocal tics with symptoms present for at least 3 months Aged 5-18 years (all genders) No tic-related medications or therapies for 8 weeks before treatment Willing to complete 8-week acupuncture treatment
Who cannot join
- Secondary tics from structural neurological lesions (e.g., epilepsy), pharmacologically induced tics, or neurodevelopmental comorbidities Severe communication barriers or cognitive impairments affecting trial participation Severe organ dysfunction meeting clinical diagnostic thresholds Concurrent participation in interventional clinical trials History of acupuncture-related syncope or presyncope episodes Absolute contraindications to acupuncture (e.g., severe needle phobia, skin infections at acupoints)
Trial locations and contacts
1 site in 1 country.
China1 site
the Third Affiliated Hospital of Zhejiang Chinese Medical University
Hangzhou, Zhejiang, 310000
About this study
Official title: A Randomized Controlled Trial on the Treatment of Chronic Tic Disorder With Nourishing the Vital Energy and Regulating the Spirit Needle Technique
This study was conducted to observe the efficacy of Nourishing the vital energy and Regulating the spirit needle technique in the treatment of chronic tic disorder through the Yale Global Tic Severity Scale (YGTSS) and the Chinese Medicine Symptom Rating Scale in order to provide a new, safe and feasible treatment option and idea for the treatment of chronic Tic Disorder.
Read the detailed description
In this study, 76 children who met the diagnostic criteria for chronic tic disorder were collected and randomly divided into the therapy group(n-38)and control group(n=38) according to a random number table. The patients were treated 3 times a week for 7 weeks, a total of 20 times. YGTSS scores and the Chinese Medicine Symptom Rating Scale were performed before and after 2 courses of treatment, and clinical efficacy and adverse events were observed in both groups, and YGTSS scores were recorded at follow-up 4 week safter the end of treatment and 12 weeks after the end of treatment, respectively. All data were statistically processed and analysed using SPSS 25.0 software, and relevant differences were compared after processing and analysis.
- Conditions
- Tic Disorders
- Being tested
- Regular acupuncture, the Nourishing the vital energyand Regulating the spirit needle technique
- Keywords
- conventional treatment, acupuncture, pediatric, clinical trial, Tic Disorders
- Medical subject headings
- Tic Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Regular acupunctureProcedure or surgery
Primary acupoints: Baihui (GV20), Hegu (LI4, bilateral), Fengchi (GB20, bilateral), Taichong (LV3, bilateral), Jinsuo (GV8), and Ganshu (BL18, bilateral). Operational procedures: Preoperative preparation identical to the treatment group; for Baihui (GV20), perform subcutaneous insertion backward (0.5 cun); for Fengchi (GB20), apply oblique insertion toward the nasal tip (0.8 cun); for Hegu (LI4) and Taichong (LV3), use perpendicular insertion (0.5 cun); for back-shu points (Ganshu BL18), rapid needling is applied due to low safety and inconvenience of retaining needles. Needle manipulation for qi activation, cycle, and frequency align with the treatment group. Treatment protocol: 3 sessions per week, 10 sessions constituting one course, totaling 20 sessions.
the Nourishing the vital energyand Regulating the spirit needle techniqueProcedure or surgery
Primary points: Zhongwan (RN12), Xiawan (RN10), Qihai (RN6), Guanyuan (RN4), Taixi (KI3/bilat.), Baihui (GV20), Sishencong (EX-HN1), Shenting (GV24), Benshen (GB13/bilat.). Supplemental points: Blinking: Zanzhu (BL2) + Taiyang (EX-HN5/affected); Mouth twitch: Dicang (ST4) + Jiache (ST6/affected); Neck twitch: Fengchi (GB20) + Shangqu (KI17/affected); Limb twitch: UL-Waiguan (SJ5) + Quchi (LI11/affected), LL-Futu (ST32) + Yanglingquan (GB34/affected); Vocal tics: Tongue Three Needles (HN23). Post-disinfection: Calm child pre-needling. Sequence: Scalp → abdomen → limbs. Techniques: Scalp points-subcutaneous backward 0.5in; Taixi (KI3)-perpendicular 0.5in, mild lift-thrust/twirl to deqi; Abdomen-abdominal acupuncture (linea alba ref.), adipose/fascial layer insertion (no muscle/deqi), 30min retention no manipulation; Rapid withdrawal with pressure. Protocol: 3 sessions/week, 10-session course, 20 sessions total.
| Study group | Role | What they receive |
|---|---|---|
| therapy group | Experimental | Not described Receives: Procedure: the Nourishing the vital energyand Regulating the spirit needle technique |
| control group | Active comparator | Not described Receives: Procedure: Regular acupuncture |
What is being measured
The primary outcome is the main question the study is designed to answer.
The Yale Global Tic Severity Scale
The Yale Global Tic Severity Scale (YGTSS) Score is designed to assess the severity of symptoms in children with Tourette's Syndrome by scoring the type of tics, frequency of tics, intensity of tics, complexity of tics, degree of interference with normal behavior, and degree of impairment of social functioning in the child, with a total score ranging from 0-75, with higher scores indicating greater severity of the child's condition.
Measured: at baseline (pre-treatment), after 8-week treatment, after 4-week follow-up
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Jul 2025
- Study start1 Aug 2021
- Primary completion11 Jul 2022
- Study completion1 Dec 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Tic DisordersStudies 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- Double blind
- Who is masked
- Investigator, Outcomes assessor
- Enrolment
- 76 participants (actual)
Sponsor and investigators
- Lead sponsor
- The Third Affiliated hospital of Zhejiang Chinese Medical University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Hong Gao, The Third Affiliated hospital of Zhejiang Chinese Medical University
- Investigators
- Hong Gao, Principal investigator, Third Affiliated Hospital of Zhejiang Chinese Medical University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07071428
- Sponsor's protocol ID
- ZSLL-ZN-2021-008-01
- Acronym
- ATPTD
- Status last verified
- Jul 2025
- First submitted
- 8 Jul 2025
- Last updated
- 5 Aug 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 5 Aug 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized Controlled Trial on the Treatment of Chronic Tic Disorder With Nourishing the Vital Energy and Regulating the Spirit Needle Technique
- ClinicalTrials.gov ID
- NCT07071428
- Acronym / sponsor ID
- ATPTD / ZSLL-ZN-2021-008-01
- Conditions
- Tic Disorders
- Keywords
- conventional treatment, acupuncture, pediatric, clinical trial, Tic Disorders
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 76 participants (actual)
- Lead sponsor
- The Third Affiliated hospital of Zhejiang Chinese Medical UniversityUniversity, hospital or other
- Study start
- 1 Aug 2021 (actual)
- Primary completion
- 11 Jul 2022 (actual)
- Study completion
- 1 Dec 2022 (actual)
- First posted
- 17 Jul 2025 (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 was conducted to observe the efficacy of Nourishing the vital energy and Regulating the spirit needle technique in the treatment of chronic tic disorder through the Yale Global Tic Severity Scale (YGTSS) and the Chinese Medicine Symptom Rating Scale in order to provide a new, safe and feasible treatment option and idea for the treatment of chronic Tic Disorder.
Detailed description
In this study, 76 children who met the diagnostic criteria for chronic tic disorder were collected and randomly divided into the therapy group(n-38)and control group(n=38) according to a random number table. The patients were treated 3 times a week for 7 weeks, a total of 20 times. YGTSS scores and the Chinese Medicine Symptom Rating Scale were performed before and after 2 courses of treatment, and clinical efficacy and adverse events were observed in both groups, and YGTSS scores were recorded at follow-up 4 week safter the end of treatment and 12 weeks after the end of treatment, respectively. All data were statistically processed and analysed using SPSS 25.0 software, and relevant differences were compared after processing and analysis.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- Double blind (investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| therapy group | Experimental | Procedure: the Nourishing the vital energyand Regulating the spirit needle technique |
| control group | Active comparator | Procedure: Regular acupuncture |
Who may qualify
- Ages
- 5 to 18 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (1 listed)
- Patients diagnosed with tic disorders per the Diagnostic and Statistical Manual of Mental Disorders, version 5 (DSM-5) criteria Presence of either motor tics or vocal tics with symptoms present for at least 3 months Aged 5-18 years (all genders) No tic-related medications or therapies for 8 weeks before treatment Willing to complete 8-week acupuncture treatment
Key exclusion criteria (1 listed)
- Secondary tics from structural neurological lesions (e.g., epilepsy), pharmacologically induced tics, or neurodevelopmental comorbidities Severe communication barriers or cognitive impairments affecting trial participation Severe organ dysfunction meeting clinical diagnostic thresholds Concurrent participation in interventional clinical trials History of acupuncture-related syncope or presyncope episodes Absolute contraindications to acupuncture (e.g., severe needle phobia, skin infections at acupoints)
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 |
|---|---|---|
| Regular acupuncturePrimary acupoints: Baihui (GV20), Hegu (LI4, bilateral), Fengchi (GB20, bilateral), Taichong (LV3, bilateral), Jinsuo (GV8), and Ganshu (BL18, bilateral). Operational procedures: Preoperative preparation identical to the treatment group; for Baihui (GV20), perform subcutaneous insertion backward (0.5 cun); for Fengchi (GB20), apply oblique insertion toward the nasal tip (0.8 cun); for Hegu (LI4) and Taichong (LV3), use perpendicular insertion (0.5 cun); for back-shu points (Ganshu BL18), rapid needling is applied due to low safety and inconvenience of retaining needles. Needle manipulation for qi activation, cycle, and frequency align with the treatment group. Treatment protocol: 3 sessions per week, 10 sessions constituting one course, totaling 20 sessions. | Procedure or surgery | control group |
| the Nourishing the vital energyand Regulating the spirit needle techniquePrimary points: Zhongwan (RN12), Xiawan (RN10), Qihai (RN6), Guanyuan (RN4), Taixi (KI3/bilat.), Baihui (GV20), Sishencong (EX-HN1), Shenting (GV24), Benshen (GB13/bilat.). Supplemental points: Blinking: Zanzhu (BL2) + Taiyang (EX-HN5/affected); Mouth twitch: Dicang (ST4) + Jiache (ST6/affected); Neck twitch: Fengchi (GB20) + Shangqu (KI17/affected); Limb twitch: UL-Waiguan (SJ5) + Quchi (LI11/affected), LL-Futu (ST32) + Yanglingquan (GB34/affected); Vocal tics: Tongue Three Needles (HN23). Post-disinfection: Calm child pre-needling. Sequence: Scalp → abdomen → limbs. Techniques: Scalp points-subcutaneous backward 0.5in; Taixi (KI3)-perpendicular 0.5in, mild lift-thrust/twirl to deqi; Abdomen-abdominal acupuncture (linea alba ref.), adipose/fascial layer insertion (no muscle/deqi), 30min retention no manipulation; Rapid withdrawal with pressure. Protocol: 3 sessions/week, 10-session course, 20 sessions total. | Procedure or surgery | therapy group |
Primary outcome
The Yale Global Tic Severity Scale
Time frame: at baseline (pre-treatment), after 8-week treatment, after 4-week follow-up
The Yale Global Tic Severity Scale (YGTSS) Score is designed to assess the severity of symptoms in children with Tourette's Syndrome by scoring the type of tics, frequency of tics, intensity of tics, complexity of tics, degree of interference with normal behavior, and degree of impairment of social functioning in the child, with a total score ranging from 0-75, with higher scores indicating greater severity of the child's condition.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Aug 2025.
- Individual participant dataSharing planned: No
Related trials for Tic Disorders
RecruitingObservational study
Distinguishing Tics and Functional Tics Using Clinical Neurophysiological Techniques
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Evaluating and Promoting Resilience in Adolescents With Tourette Syndrome
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Transcutaneous Auricular Vagus Nerve Stimulation for Chronic Tic Disorders/Tourette's Syndrome in Children and Adolescents
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Single Session Support for Parents of Children With Neurodevelopmental Disabilities Struggling With Anxious Avoidance
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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. This study is not recruiting at the moment.
Hong Gao principal investigator
Third Affiliated Hospital of Zhejiang Chinese Medical University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Regular acupuncture and the Nourishing the vital energyand Regulating the spirit needle technique in people with Tic Disorders, run by The Third Affiliated hospital of Zhejiang Chinese Medical University 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 1 inclusion and 1 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: finished, as of the sponsor's last update on 5 Aug 2025. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The Yale Global Tic Severity Scale (time frame: at baseline (pre-treatment), after 8-week treatment, after 4-week follow-up). 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 5 Aug 2025.