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NCT Number: NCT04283591

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

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.

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Key information

Conditions

Post-stroke Depression Anxiety Disorders Behavior Behavioral Symptoms Brain Diseases Cardiovascular Diseases Central Nervous System Diseases Cerebrovascular Disorders Depression Mental Disorders Nervous System Diseases Stroke Vascular Diseases

Age range

18 year–80 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Istanbul Physical Medicine Rehabilitation Training and Research Hospital

Istanbul, Turkey (Türkiye)

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Acupuncture Treatment

Procedure

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.

Conventional rehabilitation programme

Other

They will continue to receive the conventional rehabilitation programme.

Primary outcomes

  1. Hamilton Depression Rating Scale

    Time frame: 1 month

    Assessed on 17 definitions, regarding the status of patient with a scale between 0 to 4.

  2. Hamilton Anxiety Rating Scale

    Time frame: 1 month

    Assessed on 14 definitions, regarding the status of patient with a scale between 0 to 4.

Secondary outcomes

  1. Pittsburgh Sleep Quality Index

    Time frame: 1 month

    Assessed on 11 definitions, regarding the status of patient with a scale between 0 to 3.

  2. Barthel Index

    Time frame: 1 month

    Assessed on 10 definitions, regarding the status of patient with a scale between 0 to 15.

  3. Up-to-date Psychiatric Drug Use

    Time frame: 1 month

    Any change on previous drug dose or any newly prescribed drug will be noted.

Sponsors and collaborators

Lead sponsor

Istanbul Physical Medicine Rehabilitation Training and Research Hospital

Other Gov

Registry information

Official study title

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

Important dates

Study start
2019
Primary completion
2020
Study completion
2020
First posted
Feb 25, 2020
Registry last updated
Feb 9, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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