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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| ta-VNS & Electro-acupuncture | Experimental |
|
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| Citalopram | Active Comparator | citalopram for oral administration; 10mg for the first 1-3 days, 20mg for the following 4-7 daysļ¼40mg for the left days within two months |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| ta-VNS | Device | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| Montgomery-Asberg Depression Rating Scale Change | 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. | Baseline and 1 week,baseline and 2 weeks,baseline and 4 weeks,baseline and 6 weeks,baseline and 8 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| SF-McGill Pain Questionnaire | 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 | Baseline and 1 week,baseline and 2 weeks,baseline and 4 weeks,baseline and 6 weeks,baseline and 8 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Salivary cortisol levels | 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: 7ļ¼30ļ½8ļ¼30 am and 3:00-4:00 p.m | baseline and 8 weeks |
| Physiological indexes |
Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Peijing Rong, Dotor | Contact | 01064089301 | drrongpj@163.com | |
| Zhangjin Zhang, Dotor | Contact | +86 18307556273 | zhangzj@hku.hk |
| Name | Affiliation | Role |
|---|---|---|
| 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 Director |
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| ID | Term |
|---|---|
| D003863 | Depression |
| D010146 | Pain |
| ID | Term |
|---|---|
| D001526 | Behavioral Symptoms |
| D001519 | Behavior |
| D009461 | Neurologic Manifestations |
| D012816 | Signs and Symptoms |
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| ID | Term |
|---|---|
| D015283 | Citalopram |
| ID | Term |
|---|---|
| D011437 | Propylamines |
| D000588 | Amines |
| D009930 | Organic Chemicals |
| D009570 | Nitriles |
| D001572 |
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|
| Electro-acupuncture | Other | 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. |
|
| Citalopram | Drug | 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. |
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|
| SF-36 Health Survey Questionnaire | 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. | Baseline and 4 weeks, baseline and 8 weeks |
| Pittsburgh Sleep Quality Index | 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 | Baseline and 1 week,baseline and 2 weeks,baseline and 4 weeks,baseline and 6 weeks,baseline and 8 weeks |
| Hamilton Anxiety Rating Scale(HAMA) | 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. | Baseline and 1 week,baseline and 2 weeks,baseline and 4 weeks,baseline and 6 weeks,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 |
| baseline and 8 weeks |
| Adverse events that are related to treatment | Measure the incidence of adverse events of acupuncture such as fainting during acupuncture treatment. | baseline and 8 weeks |
| D013568 |
| Pathological Conditions, Signs and Symptoms |
| Benzofurans |
| D006574 | Heterocyclic Compounds, 2-Ring |
| D000072471 | Heterocyclic Compounds, Fused-Ring |
| D006571 | Heterocyclic Compounds |