Acupuncture Versus Compound Diclofenac Sodium for Pain Relief in Non-Traumatic Acute Abdominal (ACU-NTAA)

The First Affiliated Hospital of Hunan University of Traditional Chinese Medicine

Status and phase: Not yet enrolling; Phase 2; Phase 1

Conditions: Acute Abdominal Pain; Acupuncture; Opioids; Acupuncture Therapy

Treatments: Procedure: acupuncture; Combination Product: placebo; Drug: compound diclofenac sodium; Combination Product: acupuncture combined with compound diclofenac sodium

Study type: Interventional

Funder types: Other

Identifiers

NCT06982755

A2024021

Details and patient eligibility

About

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.

Full 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.

Enrollment: 176 estimated patients

Sex: All

Ages: 16 to 75 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

1. 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;
2. 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 criteria

Participants meeting any of the following criteria were excluded from the study:

1. Acute abdomen caused by trauma;

2. Super sudden diseases (e.g. acute myocardial infarction rupture of abdominal aortic aneurysm pulmonary embolism aortic dissection pericardial tamponade);

3. 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);

4. Extremely severe pain (NRS ≥ 8) with an undetermined diagnosis and requiring further assessment for a super sudden disease;

5. Inability to select acupuncture points due to skin injury or ulceration at Zusanli (ST36) on the lower limb;

6. Induration or infection at the hip injection site;

7. Patients with altered consciousness mental illness other severe chronic diseases or those who are unlikely to cooperate with acupuncture treatment;

8. 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.

9. Use of any pain medication or acupuncture within the past 6 hours;

10. Previous participation in this study;

11. Pregnant or lactating individuals.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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176 participants in 4 patient groups, including a placebo group

acupuncture group

Active Comparator group

Description:

acupuncture at Zusanli (ST36)

Treatment:

Combination Product: acupuncture combined with compound diclofenac sodium

Drug: compound diclofenac sodium

Combination Product: placebo

Procedure: acupuncture

compound diclofenac sodium group

Active Comparator group

Description:

intramuscular injection of compound diclofenac sodium injection

Treatment:

Combination Product: acupuncture combined with compound diclofenac sodium

Drug: compound diclofenac sodium

Combination Product: placebo

Procedure: acupuncture

acupuncture combined with compound diclofenac sodium group

Experimental group

Description:

acupuncture at Zusanli (ST36) and intramuscular injection of compound diclofenac sodium injection

Treatment:

Combination Product: acupuncture combined with compound diclofenac sodium

Drug: compound diclofenac sodium

Combination Product: placebo

Procedure: acupuncture

placebo group

Placebo Comparator group

Description:

superficial acupuncture at Zusanli (ST36) and intramuscular injection of normal saline

Treatment:

Combination Product: acupuncture combined with compound diclofenac sodium

Drug: compound diclofenac sodium

Combination Product: placebo

Procedure: acupuncture