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To evaluate the effect and safety of plum-blossom needle for Tourette syndrome.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Plum-blossom needle group | Experimental | 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). |
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| HRT group | Active Comparator | 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. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Plum-blossom needle group | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| change of YGTSS score from baseline at the 12th week | the symptom scale used in this trial will be the Yale Global Tic Severity Scale. (YGTSS). | baseline, week 12 |
| Measure | Description | Time Frame |
|---|---|---|
| change of YGTSS score from baseline at other point times | this outcome will be measured by the Yale Global Tic Severity Scale. | baseline, week 4, week 8, week 24. |
| CGI score | this outcome will be measured by the TS Clinical Global Impression Scale (CGI). |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Jinna Yu, Ph.D | Contact | 8610-010-88001413 | 546872837@qq.com |
| Name | Affiliation | Role |
|---|---|---|
| Jinna Yu, Ph.D | Guang'an Men Hospital of China Academy of Chinese Medical Sciences | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Guang'an Men Hospital, China Academy of Chinese Medical Sciences | Recruiting | Beijing | Beijing Municipality | 100053 | China |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 26220439 | Derived | 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. |
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We haven't get consent from patients to share their individual data with other researchers.
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| ID | Term |
|---|---|
| D005879 | Tourette Syndrome |
| ID | Term |
|---|---|
| D001480 | Basal Ganglia Diseases |
| D001927 | Brain Diseases |
| D002493 | Central Nervous System Diseases |
| D009422 | Nervous System Diseases |
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| ID | Term |
|---|---|
| D015670 | Acupuncture Therapy |
| ID | Term |
|---|---|
| D000529 | Complementary Therapies |
| D013812 | Therapeutics |
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| HRT group | Behavioral | HRT consisted of (1) self-monitoring, (2) competing responses, (3) relaxation training, (4) contingency management. |
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| week 4, week 8, week 12, week 24. |
| change of quality of life from baseline | this outcome will be measured by the Children and Adolescents' Quality of Life Scale (CAQOL) | baseline, week 12, week 24. |
| D013981 | Tic Disorders |
| D009069 | Movement Disorders |
| D020271 | Heredodegenerative Disorders, Nervous System |
| D019636 | Neurodegenerative Diseases |
| D030342 | Genetic Diseases, Inborn |
| D009358 | Congenital, Hereditary, and Neonatal Diseases and Abnormalities |
| D065886 | Neurodevelopmental Disorders |
| D001523 | Mental Disorders |