NCT07449676

Effects of an Innovative TCM-based Tui Jing Therapy on Psychological and Neurophysiological Functions in Depression

Effects of an Innovative TCM-based Tui Jing Therapy on Psychological and Neurophysiological Functions in Depression: A Randomized Controlled Study

• Status: Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 64 (estimated)
• Sponsor: The Hong Kong Polytechnic University · Academic / Other
• Sex: All
• Age: 18 Years – 55 Years
• Healthy volunteers: Not accepted

Summary

Background: Mental disorders are recognized as a major cause of disability and disease burden across the lifespan. Gua Sha is believed to improve mental health and sleep quality significantly. Tui Jing is an innovative type of Gua Sha therapy that penetrates deep into the muscles and fascia rather than just acting on the surface of the skin. Modern research has revealed that Gua Sha is extensively utilized for pain-related symptoms, and its therapeutic effects may be attributed to anti-inflammatory and immunomodulatory mechanisms. Although Gua Sha has demonstrated efficacy in treating various diseases, limited research exists regarding its impact and underlying mechanisms on mental health. This study will conduct a clinical trial to assess the efficacy of Tuijing Therapy on mental health. Autonomic function is closely associated with psychological symptoms, and HRV reflects the activation of the vagus nerve. This study aims to obtain preliminary evidence that Gua Sha can modulate HRV by regulating vagal function, potentially ameliorating psychological disorders. Population: The sample size is estimated using G\*power, and a total of 64 participants are needed. Adults without any chronic diseases who score over 14 on the HAM-D 17 and have no smoking or drinking habits will be included. Method: A randomized controlled study will be conducted with Tuijing therapy as the intervention and sham therapy as the control. The intervention group will receive the actual intervention, while the sham intervention group will undergo a sham ultrasound treatment process that does not involve the active therapeutic components. A computer-generated random allocation schedule will be compiled before commencement by a researcher not involved in recruiting participants. Tuijing therapy will be administered as arm A, while the sham control group will serve as arm B. There will be a 5-day interval between interventions. Participants in arm B will receive 4 sessions of sham ultrasound therapy, with 45 minutes for 1 month. Participants in arm A will receive 4 sessions of Tui Jing therapy for 45 minutes for 1 month. Heart rate variability, brain activity, skin reflection, pain perception, psychological symptoms, and sleep quality will be assessed as outcome measures. Outcomes: The primary outcomes of this study are the efficacy of Tui Jing therapy on depressive symptoms. As secondary outcomes, this study will assess changes in heart rate variability, brain activity, skin reflection, stress and anxiety symptoms, and sleep quality. Heart rate variability will be measured using a heart rate variability monitoring device, and brain activity will be measured by fNIRS. Sleep quality will be assessed using the Pittsburgh Sleep Quality Index (PSQI). Stress and anxiety symptoms will be evaluated using the Depression Anxiety Stress Scales (DASS).

Detailed description

Procedures: The researcher will conduct an initial telephone interview to provide study information and screen potential participants for eligibility. Each participant will receive full details about the study's purpose and will be required to sign an informed consent form. All participants will be invited to two in-person sessions before accepting any intervention. In the first session, comprehensive medical histories, brief semi-structured interviews for psychological symptoms, clinical examinations, general information, and questionnaires will be conducted to determine eligibility. Eligible participants in the first session will be included in the second session. The second session will be scheduled to collect baseline data for further analysis. Eligible participants who meet the inclusion criteria will be randomly assigned to receive either Tui Jing therapy or sham stimulation. The intervention will be conducted by a qualified therapist (Registered Chinese Medicine Practitioner in Hong Kong) from the Department of Rehabilitation Sciences at PolyU, while another qualified researcher will be responsible for clinical interviews, screening, and data collection.

Conditions

• Depression

Interventions

Type	Name	Description
OTHER	manual therapy: Tui Jing therapy	(Gua Sha + Meridian pressure) was utilized, a specialized form of Gua Sha that incorporates traditional techniques with targeted pressure on specific meridians.
DEVICE	sham ultrasound intervention	Participants will receive a sham ultrasound intervention on the same meridians. To enhance comfort and prevent cold sensations from the metal probe, the ultrasound device will be pre-warmed to body temperature. A gel, mimicking the texture of the lubricant used in Tui Jing therapy, will be applied. The device will mimic the motion, direction, duration, and frequency of the Tui Jing therapy, but without activating the ultrasound's therapeutic mode. The participants will be informed that they are accepting low-intensity ultrasound mode, which will not produce any sensory perception, ensuring in distinguishing ability between active and sham interventions

Timeline

• Start date: 2026-02-28
• Primary completion: 2026-11-30
• Completion: 2027-02-28
• First posted: 2026-03-04
• Last updated: 2026-03-06

Locations

1 site across 1 country: Hong Kong

Regulatory

• FDA-regulated device study