Clinical Efficacy and Immune Effects of Acupuncture in Patients With Comorbid Chronic Pain and Major Depression Disorder

NCT03328819 · Status: UNKNOWN · Phase: NA · Type: INTERVENTIONAL · Enrollment: 75

Last updated 2023-02-22

No results posted yet for this study

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.

Conditions

Interventions

OTHER

Acupuncture

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.

Sponsors & Collaborators

  • National Science and Technology Council

    collaborator FED
  • China Medical University Hospital

    lead OTHER

Principal Investigators

  • Hsien-Yin Liao, M.D.,Ph.D. · School of Post-Baccalaureate Chinese Medicine, College of Chinese Medicine, China Medical University

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
CROSSOVER

Eligibility

Min Age
20 Years
Max Age
65 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2017-08-01
Primary Completion
2023-07-31
Completion
2023-07-31

Countries

  • Taiwan

Study Locations

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Entities

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03328819 on ClinicalTrials.gov