The Effectiveness of Acupuncture Treatment for Post-Stroke Depression and Anxiety Disorder.
1 other identifier
interventional
54
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for not_applicable
Started Aug 2019
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
August 1, 2019
CompletedFirst Submitted
Initial submission to the registry
February 22, 2020
CompletedFirst Posted
Study publicly available on registry
February 25, 2020
CompletedPrimary Completion
Last participant's last visit for primary outcome
November 30, 2020
CompletedStudy Completion
Last participant's last visit for all outcomes
December 1, 2020
CompletedFebruary 9, 2021
February 1, 2021
1.3 years
February 22, 2020
February 6, 2021
Conditions
Keywords
Outcome Measures
Primary Outcomes (2)
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 Outcomes (3)
Pittsburgh Sleep Quality Index
1 month
Barthel Index
1 month
Up-to-date Psychiatric Drug Use
1 month
Study Arms (2)
Experimental Intervention
EXPERIMENTALAcupuncture 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.
No Intervention
OTHERControl Group: will be included in the conventional rehabilitation programme and no interventional procedures will be made.
Interventions
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.
They will continue to receive the conventional rehabilitation programme.
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Istanbul Physical Medicine Rehabilitation Training and Research Hospital
Istanbul, Turkey (Türkiye)
Related Publications (4)
Paolucci S. Epidemiology and treatment of post-stroke depression. Neuropsychiatr Dis Treat. 2008 Feb;4(1):145-54. doi: 10.2147/ndt.s2017.
PMID: 18728805BACKGROUNDZhang 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.
PMID: 19632725BACKGROUNDLi 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.
PMID: 29960288BACKGROUNDKalaoglu E, Kesiktas FN, Bucak OF, Atasoy M, Gunderci A. Effectiveness of acupuncture treatment in post-stroke depression and anxiety disorders: a prospective, randomized, controlled, single-blind study. Acupunct Med. 2024 Dec;42(6):319-325. doi: 10.1177/09645284241298294. Epub 2024 Nov 26.
PMID: 39587915DERIVED
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Eser Kalaoğlu, MD
Istanbul Physical Medicine Rehabilitation Training and Research Hospital
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- SINGLE
- Who Masked
- OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER GOV
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
February 22, 2020
First Posted
February 25, 2020
Study Start
August 1, 2019
Primary Completion
November 30, 2020
Study Completion
December 1, 2020
Last Updated
February 9, 2021
Record last verified: 2021-02