Clinical trial NCT02403258: The Effect and Safety of Plum-blossom Needle for Tourette Syndrome
Official title: The Effect and Safety of Plum-blossom Needle for Tourette Syndrome: a Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Tourette Syndrome
Keywords: acupuncture
plum-blossom needle
tourette syndrome
randomized controlled trial
Lead sponsor: Guang'anmen Hospital of China Academy of Chinese Medical Sciences
Sponsor class: OTHER
First posted: 2015-03-31
Enrollment: 60
Sex: ALL
Minimum age (years): 7
Maximum age (years): 18
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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

Detailed 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.

Eligibility criteria: 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.

Primary outcomes:
measure: change of YGTSS score from baseline at the 12th week
timeFrame: baseline, week 12
Secondary outcomes:
measure: change of YGTSS score from baseline at other point times
timeFrame: baseline, week 4, week 8, week 24.
measure: CGI score
timeFrame: week 4, week 8, week 12, week 24.
measure: change of quality of life from baseline
timeFrame: baseline, week 12, week 24.
Other outcomes:
Locations:
city: Beijing
country: China
facility: Guang'an Men Hospital, China Academy of Chinese Medical Sciences
state: Beijing
Study officials:
affiliation: Guang'an Men Hospital of China Academy of Chinese Medical Sciences
name: Jinna Yu, Ph.D
role: STUDY_CHAIR
References:
citation: Yu J, Ye Y, Li S, Liu J, Zhai Y, Zhang M, Liu Z. The effectiveness and safety of plum-blossom needle therapy for Tourette syndrome: study protocol for a randomized controlled trial. Trials. 2015 Jul 29;16:320. doi: 10.1186/s13063-015-0873-0.