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Acupuncture on GB34 for immediate analgesia and regulating pain-related anxiety for patients with Biliary Colic: A Protocol of Randomized Controlled Trial

The correlation between GB34,gallbladder and brain and its potential mechanism detected by multi-imaging techniques and MSE complexity analysis

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2300070661
Enrollment
Unknown
Registered
2023-04-19
Start date
2023-05-01
Completion date
Unknown
Last updated
2023-06-04

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

Conditions

Biliary Colic

Interventions

Acupuncture group:acupuncture
Sham acupuncture group:Park sham device

Sponsors

the Affiliated Hospital of Chengdu University of Traditional Chinese Medicine/ Chengdu University of Traditional Chinese Medicine
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 60 Years

Inclusion criteria

Inclusion criteria: 1. meet the diagnostic criteria; 2. mild tenderness in the right upper quadrant, Murphy's sign (-)/(+); 3. the score of NRS>=3; 4. BC patients aged 18 to 60 years old, without gender restrictions; 5. gallbladder stones demonstrated by radiology or ultrasonography; 6. no acupuncture treatment in the past month; 7. not participating in other clinical studies; 8. voluntarily sign the informed consent form.

Exclusion criteria

Exclusion criteria: 1. a history of jaundice; 2. presenting bile duct stones, acute cholecystitis, acute suppurative cholecystitis, gangrenous cholecystitis, incarcerated cholecystitis, gallbladder perforation with diffuse peritonitis, BC complicated with acute pancreatitis; 3. analgesics such as antispasmodic, non-steroidal anti-inflammatory drugs, choleretic are injected before acupuncture; 4. serious complications or primary diseases involving the brain, cardiovascular, liver, kidney, endocrine, or hematopoietic systems; 5. Serious digestive system diseases, such as peptic ulcer, upper gastrointestinal bleeding, gastric tumor, Crohn's disease, irritable bowel syndrome, etc.; 6. pregnant women; 7. patients participating in other clinical trials within the last three months.

Design outcomes

Primary

MeasureTime frame
the change of pain intensity from baseline to 30 min after acupuncture by evaluating the numerical rating scale (NRS);

Secondary

MeasureTime frame
The pain intensity;The degree of gastrointestinal symptoms;the Pain Anxiety Symptoms Scale-20 (PASS-20);The anxiety level during pain episodes;the Fear of Pain Questionnaire-III (FPQ-III);the Pain Catastrophizing Scale (PCS);Acupuncture Expectancy Scale;patient’s satisfaction for acupuncture;the Chinese version of the modified Massachusetts General Hospital Acupuncture Sensation Scale (C-MASS);The usage of rescue analgesia and at 30 min after needle manipulation;the recurrence rate of BC and adverse events at 72 hours after needle manipulation;

Countries

China

Contacts

Public ContactRuiRui Sun

Chengdu University of Traditional Chinese Medicine

cspsrr@126.com+86 19542816745

Outcome results

None listed

Source: ChiCTR (via WHO ICTRP) · Data processed: Feb 10, 2026