Comprehensive Acupuncture for Depressive Disorder With Comorbid Psychogenic Pain
Study Details
Study Description
Brief Summary
Experimental and clinical studies have indicated that acupuncture has a good effect for depression and comorbid pain. The purpose of this research is to compare the effect of comprehensive electro-acupuncture therapy and western medicine citalopram for for depressive disorder with comorbid psychogenic pain. This research is a assessor blinded, randomized controlled trials. 60 patients will be randomly divided into comprehensive electro-acupuncture group and western medicine citalopram for 8 weeks treatment and the therapeutic effect is done at the end of 1,2,4,6,8 week.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
Early Phase 1 |
Study Design
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Experimental: ta-VNS & Electro-acupuncture Device:ta-VNS(transcutaneous vagus nerve stimulation):2 times per day,5 consecutive days per week for two months Other:Electro-acupuncture:3 times per week, once every other day for two months |
Device: ta-VNS
The transcutaneous vagus nerve stimulation (taVNS) at auricular concha is a typical representative of TCM modernization. The taVNS regulates the autonomic nervous system, which shows a good therapeutic effect for the treatment of depression.
Other Names:
Other: Electro-acupuncture
one of the most common acupuncture methods, selecting acupoints based on traditional Chinese medicine theory. It exerts the function to regulate qi and blood circulation and balance Yang and Yin energy inside body.
|
| Active Comparator: Citalopram citalopram for oral administration; 10mg for the first 1-3 days, 20mg for the following 4-7 days；40mg for the left days within two months |
Drug: Citalopram
Citalopram is an antidepressant drug of the selective serotonin reuptake inhibitor (SSRI) class.It has U.S. Food and Drug Administration approval to treat major depression.
Other Names:
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Outcome Measures
Primary Outcome Measures
- Montgomery-Asberg Depression Rating Scale Change [Baseline and 1 week,baseline and 2 weeks,baseline and 4 weeks,baseline and 6 weeks,baseline and 8 weeks]
Measure the severity of depressive episodes in patients with mood disorders, It contents ten items, and each item is scored 0-6.(0=no depression,6=depression as bad as can be), yielding a total between 0 and 60.
Secondary Outcome Measures
- SF-McGill Pain Questionnaire [Baseline and 1 week,baseline and 2 weeks,baseline and 4 weeks,baseline and 6 weeks,baseline and 8 weeks]
Measure pain in 3 ways:1)pain rating indexes: pain intensity from feeling and emotional aspects, it includes fifteen items and each item is scored 0-3(0=no pain 3=severe) 2)present pain intensity, scored 0-5(0=no pain, 5=intense pain) 3)VAS: visual analog scale
- SF-36 Health Survey Questionnaire [Baseline and 4 weeks, baseline and 8 weeks]
Measure the self-reported living quality.It has eight sections:the physiological function, physiological function, the body pain, general health, energy, social function, emotional function and mental health.It consists of eight scaled scores, which are the weighted sums of the questions in their section.
- Pittsburgh Sleep Quality Index [Baseline and 1 week,baseline and 2 weeks,baseline and 4 weeks,baseline and 6 weeks,baseline and 8 weeks]
A self-report questionnaire that assesses sleep quality over a 1-month time interval. The measure consists of 19 individual items, creating seven components that produce one global score
- Hamilton Anxiety Rating Scale(HAMA) [Baseline and 1 week,baseline and 2 weeks,baseline and 4 weeks,baseline and 6 weeks,baseline and 8 weeks]
A psychological questionnaire used by clinicians to rate the severity of a patient's anxiety.Each of the 14 items contains some symptoms, and each group of symptoms is rated on a scale of zero to four, with four being the most severe.
Other Outcome Measures
- Salivary cortisol levels [baseline and 8 weeks]
Serum cortisol levels positively correlated with the severity of depression, so that the saliva should be collected before and after treatment. Acquisition time of saliva: 7：30～8：30 am and 3:00-4:00 p.m
- Physiological indexes [baseline and 8 weeks]
Including blood pressure, ECG, respiration, pulse check, blood routine, blood biochemistry, urine analysis to see if there is any change during treatment
- Adverse events that are related to treatment [baseline and 8 weeks]
Measure the incidence of adverse events of acupuncture such as fainting during acupuncture treatment.
Eligibility Criteria
Criteria
Inclusion Criteria:
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Conform with the diagnostic criteria of depression according to DIAGNOSTIC AND STATISTICAL MANUAL OF MENTAL DISORDERS (DSM-5TM)
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Age from 18 to 50 year-old
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Patients with the first onset depression
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Patients with mild-to-moderate depression scored 12-30 by Montgomery scale
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Patients with one psychogenic pain at least, and the degree of VAS is 3 or more
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Volunteer participants willing to cooperate and obeying the treatment
Exclusion Criteria:
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Pregnant woman
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Patients with severe primary diseases and acute diseases of heart, brain, liver, kidney and hematopoietic systems and infectious disease, malignant tumor
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Patients who can't stop taking drugs according to the requirement in the treatment period
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Patients with a history of schizophrenia and other mental disorders
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Patients with cognitive impairment or personality disorders
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Patients have serious suicide idea or suicidal behavior
Contacts and Locations
Locations
No locations specified.Sponsors and Collaborators
- China Academy of Chinese Medical Sciences
Investigators
- Study Director: Peijing Rong, Dotor, Institute of Acupuncture and Moxibustion, China Academy of Chinese Medical Sciences
- Study Director: Zhangjing Zhang, Dotor, The School of Chinese Medicine, The University of Hong Kong
Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- ChinaACMS-3