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Not yet recruiting NCT06982755

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

Phase I / Phase II Interventional Acute Abdominal Pain Acupuncture Therapy Acupuncture Opioids

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: acupuncture, compound diclofenac sodium, acupuncture combined with compound diclofenac sodium, placebo.
Who it may be relevant to
Registry conditions: Acute Abdominal Pain, Acupuncture Therapy, Acupuncture, Opioids. Basic parameters: 16 years — 75 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
Center list to be confirmed — check the primary protocol.
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

Official title

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

Overview

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.

Interventions

  • 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

Primary outcome measures

  • Pain response rate [Time frame: at 10 minutes after analgesia]
Secondary outcome measures (5)
  • The utilization rate of rescue drugs [Time frame: within 1 hour to 1 day post-analgesia]
  • Expectations with the intervention [Time frame: baseline]
  • Satisfaction with the intervention [Time frame: at 1 day after analgesia]
  • Numeric Rating Scale (NRS) score [Time frame: at 0, 1, 5, 10, 20, 30, and 60 minutes, and at 1 and 3 days post-analgesia]
  • Recurrence rate of pain [Time frame: at 1 day after analgesia]

Eligibility criteria

Inclusion criteria

  • 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 criteria

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.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
Randomized
Model
Parallel assignment
Masking
Open label
Primary purpose
Treatment

Study locations

Center list to be confirmed — check the primary protocol.

Identifiers

NCT: NCT06982755 · A2024021

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗