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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04283591
Recruitment Status : Enrolling by invitation
First Posted : February 25, 2020
Last Update Posted : April 21, 2020
Sponsor:
Information provided by (Responsible Party):
Istanbul Physical Medicine Rehabilitation Training and Research Hospital

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.


Condition or disease Intervention/treatment Phase
Post-stroke Depression Anxiety Disorders Procedure: Acupuncture Treatment Other: Rutin rehabilitation programme Not Applicable

Detailed Description:
Patients who receive inpatient stroke rehabilitation at SBU Istanbul Physical Therapy and Rehabilitation SUAM, Physical Medicine and Rehabilitation Clinic, will be included in the study considering the inclusion and exclusion criteria. Their consent will be received. Participants who volunteered for the study will be separated into the study group and control groups by stratified randomization. Initially, clinical and demographic data of all patients will be noted and Mini-Mental State Examination will be performed. Patients in the study group will be treated with acupuncture on the hemiplegic side's DU 20, EX HN 3 points and bilateral LR 3, LI 4 points twice a week for 4 weeks. During the application, the feeling of De Qi will be taken and the application will take 20 minutes. The control group will continue to receive inpatient stroke rehabilitation and no interventional procedures will be made. Measurements; Hamliton Depression and Hamilton Anxiety Scales, Pittsburg Sleep Quality Index, Barthel Index and change in psychiatric drug use will be assesed at baseline (week 0), week 4 and 8 weeks post-treatment. The adverse events observed during the study will be noted and the compliance of patients to therapy in each application will be questioned by VAS.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 54 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Treatment
Official Title: The Effectiveness of Acupuncture Treatment for Post-Stroke Depression and Anxiety Disorder: Prospective, Randomized, Controlled Trial
Actual Study Start Date : August 1, 2019
Estimated Primary Completion Date : August 1, 2020
Estimated Study Completion Date : December 1, 2020

Resource links provided by the National Library of Medicine

Drug Information available for: Rutoside

Arm Intervention/treatment
Experimental: Experimental Intervention
Intervention Group: will be treated with acupuncture on the hemiplegic side's DU 20, EX HN 3 points and bilateral LR 3, LI 4 points twice a week for 4 weeks. They also will continue to receive inpatient stroke rehabilitation.
Procedure: Acupuncture Treatment
Intervention Group will be treated with acupuncture on the hemiplegic side's DU 20, EX HN 3 points and bilateral LR 3, LI 4 points twice a week for 4 weeks.

No Intervention
Control Group: will continue to receive a rutin stroke rehabilitation programme but no interventional procedures will be made.
Other: Rutin rehabilitation programme
They will continue to receive a rutin rehabilitation programma and acupuncture treatment will not be made.




Primary Outcome Measures :
  1. Hamilton Depression Scale [ Time Frame: 1 month ]
    Assesed on 17 definitions, regarding the status of patient with a scale between 0 to 4.

  2. Hamilton Anxiety Scale [ Time Frame: 1 month ]
    Assesed on 14 definitions, regarding the status of patient with a scale between 0 to 4.


Secondary Outcome Measures :
  1. Pittsburg Sleep Quality Index [ Time Frame: 1 month ]
    Assesed on 11 definitions, regarding the status of patient with a scale between 0 to 3.

  2. Barthel Index [ Time Frame: 1 month ]
    Assesed on 10 definitions, regarding the status of patient with a scale between 0 to 15.

  3. Uptodate Psychiatric Drug Use [ Time Frame: 1 month ]
    Any change on previous drug dose or any newly prescribed drug will be noted.



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   18 Years to 80 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Minimum 2 months maximum 6 months after stroke
  • Volunteering for study
  • Mini-Mental State Examination >17

Exclusion Criteria:

  • Insomnia and depression before stroke
  • Aphasic patients
  • Sleep Apnea Syndrome
  • Psyhiatric Disorders (Learning disabilities, Mental disorder, Autism)
  • Decompansated cardiac, kidney, hepatic failure
  • Infection on Acupuncture Points
  • Pregnancy

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04283591


Locations
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Turkey
Istanbul Physical Medicine Rehabilitation Training and Research Hospital
Istanbul, Turkey
Sponsors and Collaborators
Istanbul Physical Medicine Rehabilitation Training and Research Hospital
Investigators
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Principal Investigator: Eser Kalaoğlu, MD Istanbul Physical Medicine Rehabilitation Training and Research Hospital
Publications:
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Responsible Party: Istanbul Physical Medicine Rehabilitation Training and Research Hospital
ClinicalTrials.gov Identifier: NCT04283591    
Other Study ID Numbers: IstPRMTRH-KT1
First Posted: February 25, 2020    Key Record Dates
Last Update Posted: April 21, 2020
Last Verified: April 2020

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Istanbul Physical Medicine Rehabilitation Training and Research Hospital:
stroke
acupuncture
depression
anxiety
Additional relevant MeSH terms:
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Stroke
Depression
Depressive Disorder
Anxiety Disorders
Cerebrovascular Disorders
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Vascular Diseases
Cardiovascular Diseases
Behavioral Symptoms
Mood Disorders
Mental Disorders