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

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

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.

Study Overview

• Status: Completed
• Conditions: Anxiety Disorders; Post-stroke Depression
• Intervention / Treatment: Procedure: Acupuncture Treatment; Other: Conventional Rehabilitation Programme

Detailed 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.

• Study Type: Interventional
• Enrollment (Actual): 54
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Turkey
  • Istanbul, Turkey
    • Istanbul Physical Medicine Rehabilitation Training and Research Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 80 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Experimental Intervention; 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. They also will continue to receive the conventional rehabilitation programme.	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.
Other: No Intervention; Control Group: will be included in the conventional rehabilitation programme and no interventional procedures will be made.	Other: Conventional Rehabilitation Programme; They will continue to receive the conventional rehabilitation programme.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Hamilton Depression Rating Scale	Assessed on 17 definitions, regarding the status of patient with a scale between 0 to 4.	1 month
Hamilton Anxiety Rating Scale	Assessed on 14 definitions, regarding the status of patient with a scale between 0 to 4.	1 month

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Pittsburgh Sleep Quality Index	Assessed on 11 definitions, regarding the status of patient with a scale between 0 to 3.	1 month
Barthel Index	Assessed on 10 definitions, regarding the status of patient with a scale between 0 to 15.	1 month
Up-to-date Psychiatric Drug Use	Any change on previous drug dose or any newly prescribed drug will be noted.	1 month

Collaborators and Investigators

• Sponsor: Istanbul Physical Medicine Rehabilitation Training and Research Hospital
• Investigators: Principal Investigator: Eser Kalaoğlu, MD, Istanbul Physical Medicine Rehabilitation Training and Research Hospital

Publications and helpful links

General Publications

• Paolucci S. Epidemiology and treatment of post-stroke depression. Neuropsychiatr Dis Treat. 2008 Feb;4(1):145-54. doi: 10.2147/ndt.s2017.
• 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.
• 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. doi: 10.1016/s0254-6272(17)30041-9.

Study record dates

Study Major Dates

• Study Start (Actual): August 1, 2019
• Primary Completion (Actual): November 30, 2020
• Study Completion (Actual): December 1, 2020

Study Registration Dates

• First Submitted: February 22, 2020
• First Submitted That Met QC Criteria: February 22, 2020
• First Posted (Actual): February 25, 2020

Study Record Updates

• Last Update Posted (Actual): February 9, 2021
• Last Update Submitted That Met QC Criteria: February 6, 2021
• Last Verified: February 1, 2021

More Information

Terms related to this study

• Keywords: stroke; depression; anxiety; acupuncture
• Additional Relevant MeSH Terms: Behavioral Symptoms; Mental Disorders; Cardiovascular Diseases; Vascular Diseases; Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Mood Disorders; Stroke; Depression; Depressive Disorder; Anxiety Disorders
• Other Study ID Numbers: IstPRMTRH-PSD

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No