Efficacy of Acupuncture at Acupoints Group Around the Base of Skull for Post-Stroke Depression: a Randomized Controlled Trial
Trial Snapshot
- Phase
- Not Applicable
- Status
- Recruiting
- Enrollment
- 98
- Locations
- 1
- Primary Endpoint
- The change rate of the total score of Hamilton Depression Rating Scale
Study Overview
Brief Summary
The objective of this trial is to evaluate the efficacy and safety of electroacupuncture at acupoints group around the base of skull for post-stroke depression.
Detailed Description
98 eligible participants with post-stroke depression will be recruited and randomly assigned to the experimental group and the control group in a ratio of 1:1. Participants in both groups will receive electroacupuncture or placebo acupuncture treatment at acupoints group around the base of skull 3 times a week for 4 weeks, and followed up for 24 weeks.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- Double (Participant, Outcomes Assessor)
Eligibility Criteria
- Ages
- 40 Years to 80 Years (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •Conforming to the criteria for the diagnosis of PSD recommended by the "Chinese Expert Consensus on Clinical Practice of Post-Stroke Depression";
- •Aged 40 to 80 years old;
- •The score of HDRS-24 item scale is more than 8 points and less than 35 points, that is, mild to moderate depression;
- •Has not received antidepressant treatment or has been discontinued for more than 2 weeks before entering treatment, and has not participated in other ongoing clinical trials.
Exclusion Criteria
- •Subjects with history of mental illness or family history of mental illness;
- •Subjects with severe heart, liver, kidney, hematopoietic system, endocrine and immune system diseases;
- •Subjects with dementia, aphasia, cognitive dysfunction or unable to cooperate with examination and treatment;
- •Subjects installed with the cardiac pacemaker;
- •Pregnant or lactating patients.
Arms & Interventions
Experimental group
Participants will receive electroacupuncture at Yamen(DU15), bilateral Tianzhu(BL10), Fengchi(GB20), Wangu(GB12), and Yifeng(SJ17) for 30minutes, 3 times a week for 4 weeks.
Intervention: Electroacupuncture (Device)
Control group
Participants will receive shallow needle insertion of 2-3 mm at sham acupoints without manipulation for 30minutes, 3 times a week for 4 weeks.
Intervention: Sham acupuncture (Device)
Outcomes
Primary Outcomes
The change rate of the total score of Hamilton Depression Rating Scale
Time Frame: Baseline, week 4
The therapeutic effects are assessed based upon HDRS score-reducing rate． Cure: HDRS score-reducing rate≥75％; Remarkable effect: HDRS score-reducing rate≥50％, \<75％; Improvement: HDRS score-reducing rate≥25％, \<50％; Failure: HDRS score-reducing rate\<25％．
Secondary Outcomes
- Change in the scores of National Institute of Health stroke scale (NIHSS)(Baseline, week4, week16 and week28)
- Changes in the scores of HDRS and its seven kinds of factors(Baseline, week4, week16 and week28)
- Change in the scores of Beck Depression Inventory (BDI)(Baseline, week4, week16 and week28)
- Change in the scores of Barthel Index (BI)(Baseline, week4, week16 and week28)
Investigators
Zeng Yuxiao
Doctoral candidate of China Academy of Chinese Medical Sciences
China Academy of Chinese Medical Sciences