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

Primary Purpose

Post-stroke Depression, Anxiety Disorders

Status
Completed
Phase
Not Applicable
Locations
Turkey
Study Type
Interventional
Intervention
Acupuncture Treatment
Conventional Rehabilitation Programme
Sponsored by
Istanbul Physical Medicine Rehabilitation Training and Research Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Post-stroke Depression focused on measuring stroke, acupuncture, depression, anxiety

Eligibility Criteria

18 Years - 80 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Istanbul Physical Medicine Rehabilitation Training and Research Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Other

Arm Label

Experimental Intervention

No Intervention

Arm Description

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.

Control Group: will be included in the conventional rehabilitation programme and no interventional procedures will be made.

Outcomes

Primary Outcome Measures

Hamilton Depression Rating Scale
Assessed on 17 definitions, regarding the status of patient with a scale between 0 to 4.
Hamilton Anxiety Rating Scale
Assessed on 14 definitions, regarding the status of patient with a scale between 0 to 4.

Secondary Outcome Measures

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

Full Information

First Posted
February 22, 2020
Last Updated
February 6, 2021
Sponsor
Istanbul Physical Medicine Rehabilitation Training and Research Hospital
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1. Study Identification

Unique Protocol Identification Number
NCT04283591
Brief Title
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

2. Study Status

Record Verification Date
February 2021
Overall Recruitment Status
Completed
Study Start Date
August 1, 2019 (Actual)
Primary Completion Date
November 30, 2020 (Actual)
Study Completion Date
December 1, 2020 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Istanbul Physical Medicine Rehabilitation Training and Research Hospital

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Post-stroke Depression, Anxiety Disorders
Keywords
stroke, acupuncture, depression, anxiety

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
54 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Experimental Intervention
Arm Type
Experimental
Arm Description
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.
Arm Title
No Intervention
Arm Type
Other
Arm Description
Control Group: will be included in the conventional rehabilitation programme and no interventional procedures will be made.
Intervention Type
Procedure
Intervention Name(s)
Acupuncture Treatment
Intervention Description
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.
Intervention Type
Other
Intervention Name(s)
Conventional Rehabilitation Programme
Intervention Description
They will continue to receive the conventional rehabilitation programme.
Primary Outcome Measure Information:
Title
Hamilton Depression Rating Scale
Description
Assessed on 17 definitions, regarding the status of patient with a scale between 0 to 4.
Time Frame
1 month
Title
Hamilton Anxiety Rating Scale
Description
Assessed on 14 definitions, regarding the status of patient with a scale between 0 to 4.
Time Frame
1 month
Secondary Outcome Measure Information:
Title
Pittsburgh Sleep Quality Index
Description
Assessed on 11 definitions, regarding the status of patient with a scale between 0 to 3.
Time Frame
1 month
Title
Barthel Index
Description
Assessed on 10 definitions, regarding the status of patient with a scale between 0 to 15.
Time Frame
1 month
Title
Up-to-date Psychiatric Drug Use
Description
Any change on previous drug dose or any newly prescribed drug will be noted.
Time Frame
1 month

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Eser Kalaoğlu, MD
Organizational Affiliation
Istanbul Physical Medicine Rehabilitation Training and Research Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
Istanbul Physical Medicine Rehabilitation Training and Research Hospital
City
Istanbul
Country
Turkey

12. IPD Sharing Statement

Citations:
PubMed Identifier
18728805
Citation
Paolucci S. Epidemiology and treatment of post-stroke depression. Neuropsychiatr Dis Treat. 2008 Feb;4(1):145-54. doi: 10.2147/ndt.s2017.
Results Reference
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PubMed Identifier
19632725
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.
Results Reference
background
PubMed Identifier
29960288
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.
Results Reference
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The Effectiveness of Acupuncture Treatment for Post-Stroke Depression and Anxiety Disorder.

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