Clinical Efficacy and Immune Effects of Acupuncture in Patients With Comorbid Chronic Pain and Major Depression Disorder
Unknown statusNot applicableNCT03328819
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This study has no listed site in Canada in this snapshot. It is included as part of the worldwide chronic pain corpus.
Brief summary (from the registry)
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 differs. This study aimed to investigate whether specific acupuncture intervention on pain- and depression-acupoints would have specific efficacy and immune effects in patients with comorbid chronic pain and major depressive disorder (MDD). Methods: We performed a subject- and assessor-blinded, crossover, and randomized controlled clinical trial of depression- and pain-specific acupuncture intervention and measured clinical responses and proinflammatory cytokines in patients with comorbid chronic pain and MDD. Specific acupoints for pain and depression were used in random order with a washout interval. Outcome measures During the visits at weeks 0 (baseline), 2, 4, 6 (after the first 6-week intervention), 8 (before the start of the second 6-week intervention), 10, 12, and 14 (after the second 6-week intervention), trained research nurses assessed the patients for depressive symptoms, pain symptoms, and the quality of life by using the HAM-D (Hamilton, 1960), BDI-II (Beck et al., 1996), BPI, Neurotoxicity Rating Scale (NRS), Clinical Global Impression scale (CGI), and World Health Organization Quality of Life BREF (WHOQOL-BREF). The HAM-D and BDI-II are the most frequently used observer-rated and self-report scales of depression, respectively. The BPI rapidly assesses the severity of pain and its impact on functioning. The NRS is a reliable and valid self-report measure used in the evaluation of psychiatric and physical symptoms. The CGI are measures of symptom severity, treatment response and the efficacy of treatments. The WHOQOL-BREF contains four domains related to the quality of life: physical health, psychological, social relationships and environment. Blood sample and quantification of cytokines At weeks 0 (baseline), 6 (after the first 6-week intervention), 8 (b…
Study details
- Official title
- Clinical Efficacy and Immune Effects of Acupuncture in Patients With Comorbid Chronic Pain and Major Depression Disorder: A Double-Blinded, Randomized Controlled Crossover Study
- Conditions
- Interventions
- Sponsor
- China Medical University Hospital
- Collaborators
- National Science and Technology Council
- Start date
- 2017-08-01
- Primary completion
- 2023-07-31
- Sex
- All
- Age range
- from 20 Years to 65 Years
- Results posted
- No results posted in this snapshot
- Countries
- Taiwan
- Total sites listed
- 1
Eligibility criteria
Show eligibility criteria (verbatim from the registry)
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).
Source: ClinicalTrials.gov (US National Library of Medicine), snapshot October 2026. Check the registry for current recruiting status. Record: https://clinicaltrials.gov/study/NCT03328819