Acupuncture Treatment in Pediatric Patients With Tic Disorders: A Prospective, Single-Center, Randomized Controlled Trial (ATPTD)

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.

Study Overview

• Status: Completed
• Conditions: Tic Disorders
• Intervention / Treatment: Procedure: the Nourishing the vital energyand Regulating the spirit needle technique; Procedure: Regular acupuncture

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 Type: Interventional
• Enrollment (Actual): 76
• Phase: Not Applicable

Contacts and Locations

Study Locations

• China
  • Zhejiang
    • Hangzhou, Zhejiang, China, 310000
      • the Third Affiliated Hospital of Zhejiang Chinese Medical University

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child; Adult
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

• 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

Exclusion Criteria:

• 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)

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Single Group Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: control group	Procedure: Regular acupuncture; 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.
Experimental: therapy group	Procedure: the Nourishing the vital energyand Regulating the spirit needle technique; 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	at baseline (pre-treatment), after 8-week treatment, after 4-week follow-up

Collaborators and Investigators

• Sponsor: The Third Affiliated hospital of Zhejiang Chinese Medical University
• Investigators: Principal Investigator: Hong Gao, Third Affiliated Hospital of Zhejiang Chinese Medical University

Study record dates

Study Major Dates

• Study Start (Actual): August 1, 2021
• Primary Completion (Actual): July 11, 2022
• Study Completion (Actual): December 1, 2022

Study Registration Dates

• First Submitted: July 8, 2025
• First Submitted That Met QC Criteria: July 8, 2025
• First Posted (Actual): July 17, 2025

Study Record Updates

• Last Update Posted (Actual): August 5, 2025
• Last Update Submitted That Met QC Criteria: July 31, 2025
• Last Verified: July 1, 2025

More Information

Terms related to this study

• Keywords: pediatric; clinical trial; acupuncture; Tic Disorders; conventional treatment
• Additional Relevant MeSH Terms: Neurologic Manifestations; Central Nervous System Diseases; Nervous System Diseases; Mental Disorders; Neurodevelopmental Disorders; Movement Disorders; Dyskinesias; Tic Disorders; Tics
• Other Study ID Numbers: ZSLL-ZN-2021-008-01

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No