NCT02403258

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

The Effect and Safety of Plum-blossom Needle for Tourette Syndrome: a Randomized Controlled Trial

• Status: Unknown
• Phase: N/A
• Study type: Interventional
• Enrollment: 60 (estimated)
• Sponsor: Guang'anmen Hospital of China Academy of Chinese Medical Sciences · Academic / Other
• Sex: All
• Age: 7 Years – 18 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Tourette Syndrome

Interventions

Type	Name	Description
OTHER	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.
BEHAVIORAL	HRT group	HRT consisted of (1) self-monitoring, (2) competing responses, (3) relaxation training, (4) contingency management.

Timeline

• Start date: 2015-01-01
• Primary completion: 2018-11-01
• Completion: 2018-12-01
• First posted: 2015-03-31
• Last updated: 2018-02-22

Locations

1 site across 1 country: China