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

NCT ID: NCT07071428

Last Updated: 2025-08-05

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 76 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2021-08-01
• Study Completion Date: 2022-12-01

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.

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

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: DOUBLE

Study Groups

therapy group

Group Type: EXPERIMENTAL

the Nourishing the vital energyand Regulating the spirit needle technique

Intervention Type: 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.

control group

Group Type: ACTIVE_COMPARATOR

Regular acupuncture

Intervention Type: 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.

Interventions

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.

Intervention Type: 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.

Intervention Type: PROCEDURE

Eligibility Criteria

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)

• Minimum Eligible Age: 5 Years
• Maximum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

The Third Affiliated hospital of Zhejiang Chinese Medical University

OTHER

Sponsor Role: lead

Responsible Party

Hong Gao

Deputy dean

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Hong Gao

Role: PRINCIPAL_INVESTIGATOR

Third Affiliated Hospital of Zhejiang Chinese Medical University

Locations

the Third Affiliated Hospital of Zhejiang Chinese Medical University

Hangzhou, Zhejiang, China

Countries

China

Other Identifiers

ZSLL-ZN-2021-008-01

Identifier Type: -

Identifier Source: org_study_id