Status:
NOT_YET_RECRUITING
Acupuncture Versus Compound Diclofenac Sodium for Pain Relief in Non-Traumatic Acute Abdominal
Lead Sponsor:
The First Affiliated Hospital of Hunan University of Traditional Chinese Medicine
Conditions:
Acute Abdominal Pain
Acupuncture Therapy
Eligibility:
All Genders
16-75 years
Phase:
PHASE1
PHASE2
Brief 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 ...
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 di...
Eligibility Criteria
Inclusion
- The diagnostic criteria of NTAA were as follows: ① abdominal pain was the main symptom; ② The onset time was less than 1 week; ③ The cause of abdominal pain could be traced to intra-abdominal abdominal wall chest or systemic diseases;
- Patients with NRS scores ≥4 (mild pain and above) were evaluated before inclusion; （3）16 years \< age \<75 years;
- （4）Those who were considered not to need surgery within 2 hours after initial assessment by a specialist.
Exclusion
- Participants meeting any of the following criteria were excluded from the study:
- Acute abdomen caused by trauma;
- Super sudden diseases (e.g. acute myocardial infarction rupture of abdominal aortic aneurysm pulmonary embolism aortic dissection pericardial tamponade);
- Emergent conditions requiring surgical treatment within 3 hours (e.g. rupture of liver cancer ectopic pregnancy ischemic bowel disease severe acute cholangitis peritonitis with septic shock);
- Extremely severe pain (NRS ≥ 8) with an undetermined diagnosis and requiring further assessment for a super sudden disease;
- Inability to select acupuncture points due to skin injury or ulceration at Zusanli (ST36) on the lower limb;
- Induration or infection at the hip injection site;
- Patients with altered consciousness mental illness other severe chronic diseases or those who are unlikely to cooperate with acupuncture treatment;
- Contraindications to Western medicine:
- Known allergies to diclofenac sodium or acetaminophen; ②History of asthma urticaria or allergic reactions induced by aspirin or other NSAIDs.
- Undergoing coronary artery bypass grafting (CABG) surgery. ④History of gastrointestinal bleeding or perforation following non-steroidal anti-inflammatory drugs (NSAIDs).
- Active gastrointestinal ulcers or bleeding or a history of recurrent ulcers or bleeding.
- Severe heart failure.
- Use of any pain medication or acupuncture within the past 6 hours;
- Previous participation in this study;
- Pregnant or lactating individuals.
Key Trial Info
Start Date :
June 1 2025
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
December 31 2026
Estimated Enrollment :
176 Patients enrolled
Trial Details
Trial ID
NCT06982755
Start Date
June 1 2025
End Date
December 31 2026
Last Update
May 21 2025
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