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A clinical case-control study of the phenomenon of pain sensitization at primary insomnia acupuncture points and its patterns

A clinical case-control study of the phenomenon of pain sensitization at primary insomnia acupuncture points and its patterns

Status
Active, not recruiting
Phases
Phase 1
Study type
Observational
Source
ChiCTR
Registry ID
ChiCTR2400082288
Enrollment
Unknown
Registered
2024-03-26
Start date
2024-04-01
Completion date
Unknown
Last updated
2024-04-01

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Insomnia

Interventions

Primary insomnia patient group:None

Sponsors

The Third Affiliated Hospital of Zhejiang University of Traditional Chinese Medicine
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 80 Years

Inclusion criteria

Inclusion criteria: (1) Compliance with the diagnostic criteria for insomnia disorder: based on the description of the Diagnostic and Statistical Manual of Mental Disorders (5th edition) developed by the American Psychological Association (APA), the diagnostic criteria for the PI patients in this study were as follows: A. complaints of dissatisfaction with the quantity and quality of sleep, accompanied by one or more of the following symptoms of insomnia: increased sleep latency, difficulty in maintaining sleep (frequent awakenings or difficulty in falling back to sleep after awakening), and early awakenings (and the inability to fall back to sleep); and B. the sleep disorder causes clinically significant distress or results in impairment of social, occupational, educational, academic, behavioral, or other important aspects of functioning. C. the sleep difficulty occurs at least 3 nights per week and persists for at least 1 month. D. exclude secondary insomnia due to physical or mental illness. (2) 18 = age = 80 years, gender is not limited; (3) no communication and cognitive dysfunction; (4) no use or discontinued use of psychotropic drugs such as anxiolytics within one month; (5) no major physical diseases; (6) voluntary acceptance of the study content, can complete the various scales assessment and polysomnography monitoring; (7) signed the informed consent form prior to the start of the study.

Exclusion criteria

Exclusion criteria: (1) those who did not meet the inclusion criteria; (2) those who suffered from severe mental disorders, history of severe head trauma with obvious consciousness disorders; (3) those who had severe hepatic or renal insufficiency and bleeding tendency; (4) those who were alcoholics (liquor =100ml/day), smokers (=15 cigarettes/day), drug addicts, or those who were taking psychotropic drugs; (5) those who suffered from other sleep disorders, such as sleep apnea hyperventilation syndrome, episodic sleep disorder, rapid eye movement sleep behavior disorder; (6) pregnant or breastfeeding; (7) the existence of other major diseases and poorly controlled; (8) the skin at the acupoints is damaged; (9) other people who do not want to sign the informed consent.

Design outcomes

Primary

MeasureTime frame
Pressure pain threshold at acupoints;

Secondary

MeasureTime frame
Pittsburgh Sleep Quality Index (PSQI);Anxiety Rating Scale (SAS);Depression Rating Scale (SDS);Polysomnography (PSG);Heart Rate Variability Testing (HRV);

Countries

China

Contacts

Public ContactXiaoshuai Yu; Yi Liang

The Third Affiliated Hospital of Zhejiang University of Traditional Chinese Medicine

yusunshine0108@126.com+86 178 5731 5605

Outcome results

None listed

Source: ChiCTR (via WHO ICTRP) · Data processed: Feb 4, 2026