NCT03328819

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

Status unknown NA Last updated 22 February 2023

What this trial tests

NA trial testing Acupuncture in Chronic Pain in 75 participants. Status unknown.

Timeline

1 August 2017

Primary endpoint
31 July 2023

31 July 2023

Quick facts

Lead sponsor	China Medical University Hospital
Phase	NA
Status	Status unknown
Study type	INTERVENTIONAL
Allocation	randomized
Design	crossover
Masking	double
Primary purpose	treatment
Enrollment	75
Start date	1 August 2017
Primary completion	31 July 2023
Estimated completion	31 July 2023
Sites	1 location across Taiwan

Drugs / interventions tested

• Acupuncture — full drug profile →

Conditions studied

• Chronic Pain — all drugs for Chronic Pain →
• Depression — all drugs for Depression →

Sponsor

China Medical University Hospital

Who can join

Adults 20 to 65, any sex, with Chronic Pain or Depression. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

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.

Publications & conference data

1 peer-reviewed publication reference this trial (live from Europe PMC):

1. Clinical efficacy and immune effects of acupuncture in patients with comorbid chronic pain and major depression disorder: A double-blinded, randomized controlled crossover study.
   Liao HY, Satyanarayanan SK, Lin YW, Su KP. · · 2023 · cited 33× · PMID 36948325 · DOI 10.1016/j.bbi.2023.03.016