Clinical trial NCT04283591: The Effectiveness of Acupuncture Treatment for Post-Stroke Depression and Anxiety Disorder.
Official title: The Effectiveness of Acupuncture Treatment for Post-Stroke Depression and Anxiety Disorder: Prospective, Randomized, Controlled Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Post-stroke Depression
Anxiety Disorders
Keywords: stroke
acupuncture
depression
anxiety
Lead sponsor: Istanbul Physical Medicine Rehabilitation Training and Research Hospital
Sponsor class: OTHER_GOV
First posted: 2020-02-25
Enrollment: 54
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief 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.

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.

Eligibility criteria: 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

Primary outcomes:
measure: Hamilton Depression Rating Scale
timeFrame: 1 month
measure: Hamilton Anxiety Rating Scale
timeFrame: 1 month
Secondary outcomes:
measure: Pittsburgh Sleep Quality Index
timeFrame: 1 month
measure: Barthel Index
timeFrame: 1 month
measure: Up-to-date Psychiatric Drug Use
timeFrame: 1 month
Other outcomes:
Locations:
city: Istanbul
country: Turkey
facility: Istanbul Physical Medicine Rehabilitation Training and Research Hospital
Study officials:
affiliation: Istanbul Physical Medicine Rehabilitation Training and Research Hospital
name: Eser Kalaoğlu, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Paolucci S. Epidemiology and treatment of post-stroke depression. Neuropsychiatr Dis Treat. 2008 Feb;4(1):145-54. doi: 10.2147/ndt.s2017.
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.
citation: 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.