The Effect and Safety of Plum-blossom Needle for Tourette Syndrome

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

60 participants

Study Classification

INTERVENTIONAL

Study Start Date

2015-01-31

Study Completion Date

2018-12-31

Brief Summary

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To evaluate the effect and safety of plum-blossom needle for Tourette syndrome.

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Detailed Description

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This is a randomized, controlled trial with two parallel arms. A total of 60 patients will be randomly allocated into the plum-blossom needle group (n=30) and the habit reversal training (HRT) group (n=30). 12-week treatment will be given to all patients of each group, follow-up will be made at the 12th week after treatment. The primary outcome measure will be the mean change from baseline in the total tic score on the Yale Global Tic Severity Scale (YGTSS) at the 12th week. Secondary outcome measures will include the mean changes in score of YGTSS, TS Clinical Global Impression Scale (CGI) and the Children and Adolescents' Quality of Life Scale from baseline at other time. Safety will also be evaluated.

Conditions

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Tourette Syndrome

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Outcome Assessors

Study Groups

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Plum-blossom needle group

Patients randomized into this group will receive plum-blossom needle as treatment. DU 20, DU 16, GB 20, EX-HN5, BL 15, BL 18, BL 23 will be selected as acupoints. Each point will be tapped gently one by one by plum blossom needle until the skin get slightly redness. The treatments will be given two sessions per week, consistently for 12weeks (24 sessions in all).

Group Type EXPERIMENTAL

Plum-blossom needle group

Intervention Type OTHER

Plum-blossom needle is a method of shallow insertion with multiple needles. It is made of five or seven stainless steel needles arranged in a pattern like the shape of plum blossom, thus named as 'plum-blossom needle'. Plum-blossom needle treat diseases by tapping specific skin areas or acupoints according to different illness based on the theory of meridian.

HRT group

Patients randomized into this group will receive habit reversal training (HRT) as treatment. Habit reversal training will consist of the following 4 parts: (1) self-monitoring, (2) competing responses, (3) relaxation training and (4) contingency management. The training will be given weekly in the 12 weeks (totally 12 sessions) by a special rehabilitation therapist, first two sessions 1.5 h, and remaining sessions 1 h for each treatment.

Group Type ACTIVE_COMPARATOR

HRT group

Intervention Type BEHAVIORAL

HRT consisted of (1) self-monitoring, (2) competing responses, (3) relaxation training, (4) contingency management.

Interventions

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Plum-blossom needle group

Plum-blossom needle is a method of shallow insertion with multiple needles. It is made of five or seven stainless steel needles arranged in a pattern like the shape of plum blossom, thus named as 'plum-blossom needle'. Plum-blossom needle treat diseases by tapping specific skin areas or acupoints according to different illness based on the theory of meridian.

Intervention Type OTHER

HRT group

HRT consisted of (1) self-monitoring, (2) competing responses, (3) relaxation training, (4) contingency management.

Intervention Type BEHAVIORAL

Other Intervention Names

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acupuncture plum-blossom needle

Eligibility Criteria

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Inclusion Criteria

1. Meeting the diagnostic criteria of the Diagnostic and Statistical Manual of Mental Disorders of the American Psychiatric Association (DSM-IV) for TS.
2. Aged 7 to 18.
3. Agree to participate in the trial and sign written informed consent by both guardians and subjects.

Exclusion Criteria

1. Having severe problem in heart, liver or kidney, or having hyperthyroidism.
2. After evaluated by psychiatrists based on the Kiddie-Sads-Present and Lifetime Version, those who are associated with co-morbid conditions such as mental retardation, pervasive developmental disorder, schizophrenia, mania episode, bipolar disorder, anxiety and depression and specific learning disorder will be excluded.
3. Tics symptoms caused by some drugs.
4. Currently receiving any other form of pharmacological or non-pharmacological treatment for their Tourette syndrome.
5. Patients with a history of psychotropic substance or alcohol use during the 3 months preceding screening.
6. Patients with a history of nonresponsiveness to HRT or participating in another clinical trial.

Minimum Eligible Age

7 Years

Maximum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No