The Effectiveness of Acupuncture Treatment for Post-Stroke Depression and Anxiety Disorder.

Anxiety Disorders Clinical Trial

Official title:

The Effectiveness of Acupuncture Treatment for Post-Stroke Depression and Anxiety Disorder: Prospective, Randomized, Controlled Trial

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04283591
• Other study ID #: IstPRMTRH-PSD
• Status: Completed
• Phase: N/A
• Start date: August 1, 2019
• Est. completion date: December 1, 2020

Study information

• Verified date: February 2021
• Source: Istanbul Physical Medicine Rehabilitation Training and Research Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

Poststroke depression is seen with a frequency of up to 30%. Drug options for depression and accompanying sleep problems are limited; In addition, effective doses cannot be increased depending on the comorbidities of the patients and the side effect profiles and drug interactions of the drugs used. Acupuncture has been used in Chinese traditional medicine for more than 2000 years and there are findings that it has positive effects in post-stroke depression and anxiety disorders.

The aim of this study is to examine the effectiveness and reliability of acupuncture treatment in depression and anxiety disorders developing after stroke and to reduce the need for multiple drugs and / or high-dose medication in the treatment of these complications.

The hypothesis of the study: Acupuncture is an effective and reliable treatment method for depression and anxiety disorders in stroke patients.

Description:

Patients who receive inpatient stroke rehabilitation at Istanbul Physical Medicine Rehabilitation Training and Research Hospital, Physical Medicine and Rehabilitation Clinic, will be included in the study by the inclusion and exclusion criteria. Their informed consent will be received. Initially, clinical and demographic data of all patients will be noted. Participants who volunteered for the study will be separated into the acupuncture treatment group and the control group by simple random sampling. Both the acupuncture treatment group and the control group will be included in the conventional rehabilitation program 2 hours a day, 7 days a week, for 8 weeks. In addition the acupuncture treatment group will get acupuncture treatment which will be applied to Baihui (DU20), Yintang (EX-HN3) points and bilateral Tai Chong (LR3), Hegu (LI4) points for 4 weeks, twice a week. During the application, the feeling of De Qi will be taken and the application will take 20 minutes. Measurements; Hamilton Depression Rating Scales, Hamilton Anxiety Rating Scales, Pittsburg Sleep Quality Index, Barthel Index, and change in psychiatric drug use will be assessed at baseline (week 0), 4th and 8th week post-treatment. The adverse events observed during the study will be noted and the compliance of patients in each application will be questioned by visual analog scale.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 54
• Est. completion date: December 1, 2020
• Est. primary completion date: November 30, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 80 Years

Eligibility

Inclusion Criteria:

• Minimum 2 months maximum 6 months after stroke

• Volunteering for study

• Mini-Mental State Examination >17

• Patients with Hamilton Depression Rating Scale> 7 and/or Hamilton Anxiety Rating Scale> 4 assessed by the psychiatrist

Exclusion Criteria:

• Insomnia and depression before a stroke

• Aphasic patients

• Sleep Apnea Syndrome

• Psychiatric Disorders (Learning disabilities, Mental disorder, Autism)

• Decompensated cardiac, kidney, hepatic failure

• Infection on Acupuncture Points

• Pregnancy

Related Conditions & MeSH terms

• Anxiety Disorders
• Depression
• Depressive Disorder
• Post-stroke Depression
• Stroke

Intervention

Procedure:
• Acupuncture Treatment
Acupuncture Treatment Group will get acupuncture treatment which will be applied to Baihui (DU20), Yintang (EX-HN3) points of the hemiplegic side and bilateral Tai Chong (LR3), Hegu (LI4) points for 4 weeks, twice a week.

Other:
• Conventional Rehabilitation Programme
They will continue to receive the conventional rehabilitation programme.

Locations

Country	Name	City	State
Turkey	Istanbul Physical Medicine Rehabilitation Training and Research Hospital	Istanbul

Sponsors (1)

Lead Sponsor	Collaborator
Istanbul Physical Medicine Rehabilitation Training and Research Hospital

Country where clinical trial is conducted

Turkey, 

References & Publications (3)

Li M, Zhang B, Meng Z, Sha T, Han Y, Zhao H, Zhang C. Effect of Tiaoshen Kaiqiao acupuncture in the treatment of ischemic post-stroke depression: a randomized controlled trial. J Tradit Chin Med. 2017 Apr;37(2):171-8. — View Citation

Paolucci S. Epidemiology and treatment of post-stroke depression. Neuropsychiatr Dis Treat. 2008 Feb;4(1):145-54. — View Citation

Zhang ZJ, Chen HY, Yip KC, Ng R, Wong VT. The effectiveness and safety of acupuncture therapy in depressive disorders: systematic review and meta-analysis. J Affect Disord. 2010 Jul;124(1-2):9-21. doi: 10.1016/j.jad.2009.07.005. Epub 2009 Jul 26. Review. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Hamilton Depression Rating Scale	Assessed on 17 definitions, regarding the status of patient with a scale between 0 to 4.	1 month
Primary	Hamilton Anxiety Rating Scale	Assessed on 14 definitions, regarding the status of patient with a scale between 0 to 4.	1 month
Secondary	Pittsburgh Sleep Quality Index	Assessed on 11 definitions, regarding the status of patient with a scale between 0 to 3.	1 month
Secondary	Barthel Index	Assessed on 10 definitions, regarding the status of patient with a scale between 0 to 15.	1 month
Secondary	Up-to-date Psychiatric Drug Use	Any change on previous drug dose or any newly prescribed drug will be noted.	1 month