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

NCT07071428 | Completed

• 1 other identifier: ZSLL-ZN-2021-008-01
• Study Type: interventional
• Target: 76
• Locations: 1 country
• Sites: 1

Brief 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 option and idea for the treatment of chronic Tic Disorder.

Conditions

Tic Disorders

Keywords

conventional treatment; acupuncture; pediatric; clinical trial; Tic Disorders

Outcome Measures

Primary Outcomes (1)

• 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

Study Arms (2)

therapy group

EXPERIMENTAL

Procedure: the Nourishing the vital energyand Regulating the spirit needle technique

control group

ACTIVE COMPARATOR

Procedure: Regular acupuncture

Interventions

Regular acupuncture PROCEDURE

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.

control group

the Nourishing the vital energyand Regulating the spirit needle technique PROCEDURE

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.

therapy group

Eligibility Criteria

• Age: 5 Years - 18 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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)

Sponsors & Collaborators

• The Third Affiliated hospital of Zhejiang Chinese Medical University: lead

Study Sites (1)

the Third Affiliated Hospital of Zhejiang Chinese Medical University

Hangzhou, Zhejiang, 310000, China

Location

MeSH Terms

Conditions

Tic Disorders

Condition Hierarchy (Ancestors)

Movement Disorders; Central Nervous System Diseases; Nervous System Diseases; Neurodevelopmental Disorders; Mental Disorders

Study Officials

• Hong Gao

  Third Affiliated Hospital of Zhejiang Chinese Medical University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Deputy dean

Study Record Dates

• First Submitted: July 8, 2025
• First Posted: July 17, 2025
• Study Start: August 1, 2021
• Primary Completion: July 11, 2022
• Study Completion: December 1, 2022
• Last Updated: August 5, 2025

Record last verified: 2025-07

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)