Clinical Efficacy and Immune Effects of Acupuncture in Patients With Comorbid Chronic Pain and Major Depression Disorder
1 other identifier
interventional
75
1 country
1
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 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 (before the start of the second 6-week intervention), and 14 (after the second 6-week intervention), peripheral venous blood samples (20 mL per time) were collected from the patients.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for not_applicable chronic-pain
Started Aug 2017
Longer than P75 for not_applicable chronic-pain
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
August 1, 2017
CompletedFirst Submitted
Initial submission to the registry
October 4, 2017
CompletedFirst Posted
Study publicly available on registry
November 1, 2017
CompletedPrimary Completion
Last participant's last visit for primary outcome
July 31, 2023
CompletedStudy Completion
Last participant's last visit for all outcomes
July 31, 2023
CompletedFebruary 22, 2023
February 1, 2023
6 years
October 4, 2017
February 21, 2023
Conditions
Keywords
Outcome Measures
Primary Outcomes (2)
The change of Hamilton Rating Scale for Depression (HAMD)
To analysis the efficacy of acupuncture on chronic pain
At Week 0, 2, 4, 6, 8, 10, 12, 14.
The change of Brief Pain Inventory (BPI)
To analysis the efficacy of acupuncture on major depression disorder
At Week 0, 2, 4, 6, 8, 10, 12, 14.
Secondary Outcomes (14)
The change of Beck Depressive Inventory (BDI-II)
At Week 0, 2, 4, 6, 8, 10, 12, 14.
The change of Neurotoxicity Rating Scale (NTRS)
At Week 0, 2, 4, 6, 8, 10, 12, 14.
The change of WHO Quality of Life Questionnaire (WHOQoL)
At Week 0, 2, 4, 6, 8, 10, 12, 14.
The change of Clinical Global Inventory (CGI)
At Week 0, 2, 4, 6, 8, 10, 12, 14.
change of tumor necrosis factor α in plasma
On Weeks 0 (baseline), 6 (first section finish), 8(before second section), and 14 (second section finish)
- +9 more secondary outcomes
Study Arms (2)
Acupuncture for Depression/Acupuncture for pain
EXPERIMENTALThe computer-generated permuted block randomization was used so that the participating patients were randomly assigned on an exactly 1:1 ratio to either the depression-pain group, in which the depression-specific acupoints were first targeted (12 sessions over six weeks), followed by the pain-specific acupoints (12 sessions over six weeks)
Acupuncture for pain/Acupuncture for Depression
EXPERIMENTALThe computer-generated permuted block randomization was used so that the participating patients were randomly assigned on an exactly 1:1 ratio to either the depression-pain group, in which the pain-specific acupoints (six weeks 12 sessions) were first targeted followed by the depression-specific acupoints (six weeks 12 sessions).
Interventions
The following depression-specific acupoints: Baihui (Du-20), Yintang (EX-HN3), Sishencong (EX-HN1), bilateral Cuanzhu (BL2), bilateral Toulinqi (GB15), bilateral Neiguan (PC6), bilateral Shenmen (HT7), bilateral Sanyinjiao (SP6), and bilateral Taichong (LR3). These depression-specific acupoints could raise up the qi, calm the mind, smooth liver qi stagnation, promote blood circulation, remove blood stasis, and nourish yin. The following pain-specific acupoints: bilateral Fengchi (GB20), bilateral Jianjing (GB21), bilateral Quchi (LI11), bilateral Shousanli (LI10), bilateral Hegu (LI4), bilateral Wangu (SI4), bilateral Shenshu (BL23), bilateral Huantiao (GB30), bilateral Weizhong (BL40), bilateral Feiyang (BL58), bilateral Yanglingquan (GB34), bilateral Yinlingquan (SP9), and bilateral Taixi (KI3). These pain-specific acupoints could eliminate wind, relax muscles, promote blood circulation, and supplement the kidney.
Eligibility Criteria
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
China Medical University Hospital
Taichung, 40447, Taiwan
Related Publications (1)
Liao HY, Satyanarayanan SK, Lin YW, Su KP. Clinical efficacy and immune effects of acupuncture in patients with comorbid chronic pain and major depression disorder: A double-blinded, randomized controlled crossover study. Brain Behav Immun. 2023 May;110:339-347. doi: 10.1016/j.bbi.2023.03.016. Epub 2023 Mar 21.
PMID: 36948325DERIVED
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Hsien-Yin Liao, M.D.，Ph.D.
School of Post-Baccalaureate Chinese Medicine, College of Chinese Medicine, China Medical University
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Who Masked
- PARTICIPANT, OUTCOMES ASSESSOR
- Masking Details
- According to the computer-generated permuted block randomization, 75 sealed envelopes containing notes with 1\~75 numbers assigned to the depression-pain group or pain-depression group. Before each new treatment course began, the acupuncturists opened one of the 75 envelopes in numerical order and treated the newly included participants with pain-specific or depression-specific acupoints, according to the notes. The intervention and research teams were physically segregated during the trial. The patients, the assessor, and the biostatistician were blinded to the allocation process until the data were analyzed. After the interventions were completed, the patients were asked to indicate the interventions they perceived to have received during the first and second six-week periods. Research nurses recorded the results.
- Purpose
- TREATMENT
- Intervention Model
- CROSSOVER
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
October 4, 2017
First Posted
November 1, 2017
Study Start
August 1, 2017
Primary Completion
July 31, 2023
Study Completion
July 31, 2023
Last Updated
February 22, 2023
Record last verified: 2023-02