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

Guang'anmen Hospital of China Academy of Chinese Medical Sciences

Status: Unknown

Conditions: Tourette Syndrome

Treatments: Behavioral: HRT group; Other: Plum-blossom needle group

Study type: Interventional

Funder types: Other

Identifiers

NCT02403258

2014S298

Details and patient eligibility

About

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

Full description

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.

Enrollment: 60 estimated patients

Sex: All

Ages: 7 to 18 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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60 participants in 2 patient groups

Plum-blossom needle group

Experimental group

Description:

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).

Treatment:

Other: Plum-blossom needle group

HRT group

Active Comparator group

Description:

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.

Treatment:

Behavioral: HRT group