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

NCT06982755 | Not Yet Recruiting Phase 1

• 1 other identifier: A2024021
• Study Type: interventional
• Target: 176
• Locations: 0 countries
• Sites: N/A

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 department (ED) compared with acupuncture or compound diclofenac sodium injection alone.

Conditions

Acute Abdominal Pain; Acupuncture Therapy; Acupuncture; Opioids

Keywords

Acute abdominal pain; Non-Traumatic Acute Abdomen; Non-traumatic acute abdomen early analgesia; Acupuncture therapy; Acupuncture; Zusanli point, ST36; Diclofenac sodium; Emergency environment; Opioids; Non-steroidal anti-inflammatory drugs ，NSAIDs; Acetaminophen

Outcome Measures

Primary Outcomes (1)

• Pain response rate

  Using the Numeric Rating Scale (NRS) score evaluate the proportion of individuals within the group who achieved a therapeutic index of ≥50% at the 10th minute post-treatment compared to baseline

  at 10 minutes after analgesia

Secondary Outcomes (5)

• The utilization rate of rescue drugs

  within 1 hour to 1 day post-analgesia

• Expectations with the intervention

  baseline

• Satisfaction with the intervention

  at 1 day after analgesia

• Numeric Rating Scale (NRS) score

  at 0, 1, 5, 10, 20, 30, and 60 minutes, and at 1 and 3 days post-analgesia

• Recurrence rate of pain

  at 1 day after analgesia

Other Outcomes (1)

• Avatar Incidence of adverse events

  through study completion, an average of 3 days

Study Arms (4)

acupuncture group

ACTIVE COMPARATOR

acupuncture at Zusanli (ST36)

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

compound diclofenac sodium group

ACTIVE COMPARATOR

intramuscular injection of compound diclofenac sodium injection

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

acupuncture combined with compound diclofenac sodium group

EXPERIMENTAL

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

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

placebo group

PLACEBO COMPARATOR

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

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

Interventions

acupuncture PROCEDURE

acupuncture at Zusanli (ST36); sample size: 44

acupuncture combined with compound diclofenac sodium group; acupuncture group; compound diclofenac sodium group; placebo group

compound diclofenac sodium DRUG

intramuscular injection of compound diclofenac sodium injection; sample size: 44

Also known as: compound Diclofenac Sodium Injection

acupuncture combined with compound diclofenac sodium group; acupuncture group; compound diclofenac sodium group; placebo group

acupuncture combined with compound diclofenac sodium COMBINATION_PRODUCT

acupuncture at Zusanli (ST36) and intramuscular injection of compound diclofenac sodium injection; sample size: 44

acupuncture combined with compound diclofenac sodium group; acupuncture group; compound diclofenac sodium group; placebo group

placebo COMBINATION_PRODUCT

superficial acupuncture at Zusanli (ST36) and intramuscular injection of normal saline; sample size: 44

acupuncture combined with compound diclofenac sodium group; acupuncture group; compound diclofenac sodium group; placebo group

Eligibility Criteria

• Age: 16 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• 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;
• （4）Those who were considered not to need surgery within 2 hours after initial assessment by a specialist.

You may not qualify if:

• 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;

Sponsors & Collaborators

• The First Affiliated Hospital of Hunan University of Traditional Chinese Medicine: lead

MeSH Terms

Conditions

Abdomen, Acute

Interventions

Acupuncture Therapy

Condition Hierarchy (Ancestors)

Abdominal Pain; Pain; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Signs and Symptoms, Digestive

Intervention Hierarchy (Ancestors)

Complementary Therapies; Therapeutics

Study Officials

• Zhong Feng, Ph.D.

  Hunan University of Traditional Chinese Medicine

  STUDY DIRECTOR

Central Study Contacts

Zhong Feng, Ph.D.

CONTACT

18711009633; ahtcmzhong@163.com

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: NONE
• Masking Details: This study is classified as exploratory research. This designation is due to the specialized techniques required for acupuncture and sham acupuncture, as well as the significant differences in intervention methods between acupuncture and intramuscular injection of diclofenac sodium. Given these factors, a double-blind approach was not feasible in this study. To minimize open-label bias, the principal investigators, operators, outcome assessors, data collectors, and statistical analysts will act independently in all aspects of the trial.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 24, 2025
• First Posted: May 21, 2025
• Study Start: June 1, 2025
• Primary Completion: December 31, 2025
• Study Completion (Estimated): December 31, 2026
• Last Updated: May 21, 2025

Record last verified: 2025-05