NCT06982755

Acupuncture Versus Compound Diclofenac Sodium for Pain Relief in Non-Traumatic Acute Abdominal

Effect of Acupuncture on Early Analgesia of Non-traumatic Acute Abdomen is Discussed Based on the Experience of Sanli Acupoint for Du-fu Diseases :A Prospective Randomized Controlled pRCT Study

• Status: Not Yet Recruiting
• Phase: Phase 1 / Phase 2
• Study type: Interventional
• Enrollment: 176 (estimated)
• Sponsor: The First Affiliated Hospital of Hunan University of Traditional Chinese Medicine · Academic / Other
• Sex: All
• Age: 16 Years – 75 Years
• Healthy volunteers: Not accepted

Summary

The investigators designed this clinical study to evaluate the efficacy and safety of semi-standardized acupuncture and moxibustion combined with compound diclofenac sodium injection in the emergency department (ED) compared with acupuncture or compound diclofenac sodium injection alone.

Detailed description

This study is a prospective, parallel-controlled, open-label randomized controlled trial (RCT). The Numeric Rating Scale (NRS) was used to assess pain intensity. The primary outcome measure was the difference in pain response rates between the combined intervention group, the acupuncture-only group, and the diclofenac sodium combination group at 10 minutes post-treatment compared to baseline. Secondary outcomes included treatment response rates, NRS scores, pain recurrence rates, rescue medication rates, and adverse events at each observation time point across the three groups. Additionally, a placebo group was included to exploratorily assess the placebo effect of the intervention.

Conditions

• Acute Abdominal Pain
• Acupuncture Therapy
• Acupuncture
• Opioids

Interventions

Type	Name	Description
PROCEDURE	acupuncture	acupuncture at Zusanli (ST36); sample size: 44
DRUG	compound diclofenac sodium	intramuscular injection of compound diclofenac sodium injection; sample size: 44
COMBINATION_PRODUCT	acupuncture combined with compound diclofenac sodium	acupuncture at Zusanli (ST36) and intramuscular injection of compound diclofenac sodium injection; sample size: 44
COMBINATION_PRODUCT	placebo	superficial acupuncture at Zusanli (ST36) and intramuscular injection of normal saline; sample size: 44

Timeline

• Start date: 2025-06-01
• Primary completion: 2025-12-31
• Completion: 2026-12-31
• First posted: 2025-05-21
• Last updated: 2025-05-21