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

Primary Purpose

Tourette Syndrome

Status

Unknown status

Phase

Not Applicable

Locations

China

Study Type

Interventional

Intervention

Plum-blossom needle group

HRT group

About this trial

This is an interventional treatment trial for Tourette Syndrome focused on measuring acupuncture, plum-blossom needle, tourette syndrome, randomized controlled trial

Eligibility Criteria

7 Years - 18 Years (Child, Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

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

Exclusion Criteria:

Having severe problem in heart, liver or kidney, or having hyperthyroidism.
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.
Tics symptoms caused by some drugs.
Currently receiving any other form of pharmacological or non-pharmacological treatment for their Tourette syndrome.
Patients with a history of psychotropic substance or alcohol use during the 3 months preceding screening.
Patients with a history of nonresponsiveness to HRT or participating in another clinical trial.

Sites / Locations

Guang'an Men Hospital, China Academy of Chinese Medical SciencesRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Plum-blossom needle group

HRT group

Arm 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).

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.

Outcomes

Primary Outcome Measures

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).

Secondary Outcome Measures

change of YGTSS score from baseline at other point times

this outcome will be measured by the Yale Global Tic Severity Scale.

CGI score

this outcome will be measured by the TS Clinical Global Impression Scale (CGI).

change of quality of life from baseline

this outcome will be measured by the Children and Adolescents' Quality of Life Scale (CAQOL)

Full Information

NCT ID

NCT02403258

First Posted

March 26, 2015

Last Updated

February 16, 2018

Sponsor

Guang'anmen Hospital of China Academy of Chinese Medical Sciences

1. Study Identification

Unique Protocol Identification Number

NCT02403258

Brief Title

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

2. Study Status

Record Verification Date

February 2018

Overall Recruitment Status

Unknown status

Study Start Date

January 2015 (undefined)

Primary Completion Date

November 2018 (Anticipated)

Study Completion Date

December 2018 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

Guang'anmen Hospital of China Academy of Chinese Medical Sciences

4. Oversight

Data Monitoring Committee

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Tourette Syndrome

Keywords

acupuncture, plum-blossom needle, tourette syndrome, randomized controlled trial

7. Study Design

Primary Purpose

Treatment

Study Phase

Not Applicable

Interventional Study Model

Parallel Assignment

Masking

Outcomes Assessor

Allocation

Randomized

Enrollment

60 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

Plum-blossom needle group

Arm Type

Experimental

Arm Description

Arm Title

HRT group

Arm Type

Active Comparator

Arm Description

Intervention Type

Other

Intervention Name(s)

Plum-blossom needle group

Other Intervention Name(s)

acupuncture, plum-blossom needle

Intervention Description

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

Behavioral

Intervention Name(s)

HRT group

Intervention Description

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

Primary Outcome Measure Information:

Title

change of YGTSS score from baseline at the 12th week

Description

the symptom scale used in this trial will be the Yale Global Tic Severity Scale. (YGTSS).

Time Frame

baseline, week 12

Secondary Outcome Measure Information:

Title

change of YGTSS score from baseline at other point times

Description

this outcome will be measured by the Yale Global Tic Severity Scale.

Time Frame

baseline, week 4, week 8, week 24.

Title

CGI score

Description

this outcome will be measured by the TS Clinical Global Impression Scale (CGI).

Time Frame

week 4, week 8, week 12, week 24.

Title

change of quality of life from baseline

Description

this outcome will be measured by the Children and Adolescents' Quality of Life Scale (CAQOL)

Time Frame

baseline, week 12, week 24.

10. Eligibility

Sex

All

Minimum Age & Unit of Time

7 Years

Maximum Age & Unit of Time

18 Years

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion Criteria: Meeting the diagnostic criteria of the Diagnostic and Statistical Manual of Mental Disorders of the American Psychiatric Association (DSM-IV) for TS. Aged 7 to 18. Agree to participate in the trial and sign written informed consent by both guardians and subjects. Exclusion Criteria: Having severe problem in heart, liver or kidney, or having hyperthyroidism. 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. Tics symptoms caused by some drugs. Currently receiving any other form of pharmacological or non-pharmacological treatment for their Tourette syndrome. Patients with a history of psychotropic substance or alcohol use during the 3 months preceding screening. Patients with a history of nonresponsiveness to HRT or participating in another clinical trial.

Central Contact Person:

First Name & Middle Initial & Last Name or Official Title & Degree

Jinna Yu, Ph.D

Phone

8610-010-88001413

546872837@qq.com

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Jinna Yu, Ph.D

Organizational Affiliation

Guang'an Men Hospital of China Academy of Chinese Medical Sciences

Official's Role

Study Chair

Facility Information:

Facility Name

Guang'an Men Hospital, China Academy of Chinese Medical Sciences

City

Beijing

State/Province

Beijing

ZIP/Postal Code

100053

Country

China

Individual Site Status

Recruiting

12. IPD Sharing Statement

Plan to Share IPD

Undecided

IPD Sharing Plan Description

We haven't get consent from patients to share their individual data with other researchers.

Citations:

PubMed Identifier

26220439

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.

Results Reference

derived

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

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