NCT04319562

Needle-embedding Therapy Alleviates Depressive Symptoms and Resets the Function of Executive Control System in Subthreshold Depression People

Needle-embedding Therapy Alleviates Depressive Symptoms and Resets the Function of Executive Control System in Subthreshold Depression People: a Randomized Controlled Study

• Status: Unknown
• Phase: N/A
• Study type: Interventional
• Enrollment: 80 (estimated)
• Sponsor: Guangdong Provincial Hospital of Traditional Chinese Medicine · Academic / Other
• Sex: All
• Age: 18 Years – 30 Years
• Healthy volunteers: Accepted

Summary

The main objective of this trial is to evaluate the effectiveness of treating subthreshold depression by needle-embedding therapy. On this basis, the investigators will discuss the mechanism of needle-embedding therapy improving executive function control system.

Detailed description

The needle-embedding therapy is a method of acupuncture, which inserts the intradermal thumbtack needle into skin quickly. The needle will be replaced after 2 or 3 days. This treatment has a great efficacy on subthreshold depression (SD) and it is easy to promote. However, its clinical effect remains to be studied. In this study, the researchers used this method to treat SD by selecting the back shu acupoint and ear acupoint. This research aims to evaluate the effectiveness of treating subthreshold depression by needle-embedding therapy. On this basis, from the perspective of psychology, this project takes the cognitive function of the SD people as the entry point, in order to find the scientific indicators to quantify the SD people clinically from the perspective of the executive function control system. At the same time, magnetic resonance imaging(MRI) was used to compare and analyze the brain executive control system of subthreshold depression group and normal group, and to observe the specificity of brain structure, network and function of subthreshold depression group. Finally, through the comparative analysis of the brain executive control system of the subthreshold depression group with intradermal thumbtack needle therapy and shame intradermal thumbtack needle therapy, the neural mechanism of needle-embedding therapy promoting the function reset of the brain executive control system was speculated based on the evaluation of the efficacy of needle-embedding therapy. 80 patients will be divided into two groups randomly, intradermal thumbtack needle group or shame intradermal thumbtack needle group, and evaluated before and after intervention. The primary study outcomes will be depressive symptoms as measured by the PHQ-9. Secondary outcomes will be the ability of executive control system, health-related quality of life and anxiety symptoms measured as described previously. Tertiary outcomes will be the difference between the results of fMRI of SD people and normal brain database, and the difference between the treatment group and control group, which can observe the specificity of brain structure, network and function in subthreshold depression. The results will be analyzed and presented descriptively, as of statistical comparisons of pre- and post-treatment and the relationship between the groups.

Conditions

• Subthreshold Depression

Interventions

Type	Name	Description
PROCEDURE	needle-embedding therapy	First group is comprised of Xinshu (BL15), Ganshu (BL18), Juque (CV14) bilaterally, and Xin and Gan of auricular point on the left ear. Second group includes Shentang (BL44), Hunmen (BL47), Jiuwei (RN15) bilaterally, and Xin and Gan of auricular point on the right side. After skin cleansing with a 75% alcohol swab, intradermal thumbtack needle will be quickly inserted into the skin and embedded at acupoints mentioned above bilaterally. The needles will remain in the acupoints for 3 days and they will be removed by the therapists at next visit. This also can ensure better implementation of the blind method.Participants are required to receive this treatment twice a week. The specification of the needle used in the back shu point is φ9mm 0.20×1.5mm (Seirin® PYONEX; Seirin Corporation, Shizuoka, Japan), that in the auricular point is φ9mm 0.20×0.6mm (Seirin® PYONEX; Seirin Corporation, Shizuoka, Japan).
DEVICE	shame needle-embedding therapy	The acupoint selection in this group is the same as in the needle-embedding therapy group, except that the shame intradermal needles will be used. After skin cleansing with a 75% alcohol swab, the shame intradermal needles，instead of insert into the skin, it can only stick on the surface of the skin. It also will be removed by the therapists after 3 days. This takes place twice a week. The specification of the shame needle is the same as above.

Timeline

• Start date: 2020-04-01
• Primary completion: 2022-08-31
• Completion: 2022-08-31
• First posted: 2020-03-24
• Last updated: 2020-03-24

Locations

1 site across 1 country: China