Status:
UNKNOWN
Clinical Efficacy and Immune Effects of Acupuncture in Patients With Comorbid Chronic Pain and Major Depression Disorder
Lead Sponsor:
China Medical University Hospital
Collaborating Sponsors:
National Science and Technology Council
Conditions:
Chronic Pain
Depression
Eligibility:
All Genders
20-65 years
Phase:
NA
Brief Summary
Background: Depression and pain are highly comorbid and share biological mechanisms. Acupuncture is commonly used to manage both pain and depression, but the choice of acupoints for specific disorders...
Detailed Description
Participants The present study participants were patients who visited China Medical University Hospital. In a previous 8-week parallel trial with two intervention groups, namely acupuncture plus dulox...
Eligibility Criteria
Inclusion
- Inclusion criteria Patients were included if they (a) were aged ≥20 years, (b) were diagnosed as having MDD following the Diagnostic and Statistical Manual of Mental Disorders, Fifth Edition, (c) received a score ≥18 on the 21-item HAM-D, (d) reported experiencing persistent pain for more than three months and obtained a score ≥4 on the fifth item of the BPI, (e) were assessed as being moderately ill score ≥4 based on the Clinical Global Impression (CGI) scale, (f) had a consistent (in terms of dosage and type of medication or treatment) analgesic and antidepressive medication regimen and psychotherapy regimen in the four weeks prior to enrollment, and (g) had not received acupuncture and herbal treatments in the two weeks prior to enrollment. The Brief Pain Inventory (BPI) user guide indicates that BPI is one of the most widely used measurement tools for assessing clinical pain. The BPI could assess pain severity and measure how much pain has interfered with seven daily activities. The third, fourth, and fifth items of the BPI long form assess pain at its "worst," "least," "average," within recall period of one week. Because the pain of the patients with comorbid chronic pain and depression always varied on and off, the fifth item of the BPI long form could help us to assess the subjects' average pain severity rather than the worst or least pain severity (Cleeland and Ryan, 1991; Keller et al., 2004).
- Exclusion criteria Patients were excluded if they (a) had MDD caused by substance abuse or pregnancy, (b) had their first onset of MDD after the age of 65 years, (c) had experienced malignant pain caused by cancer pain syndrome, (d) had experienced visceral pain (e.g., stomachache), or (e) had experienced referred pain (e.g., back pain due to pancreatitis). Changes in the brain, such as stroke, often cause the first onset of MDD after the age of 65 years (Cojocaru et al., 2013).
Exclusion
Key Trial Info
Start Date :
August 1 2017
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
July 31 2023
Estimated Enrollment :
75 Patients enrolled
Trial Details
Trial ID
NCT03328819
Start Date
August 1 2017
End Date
July 31 2023
Last Update
February 22 2023
Active Locations (1)
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1
China Medical University Hospital
Taichung, Taiwan, 40447