Clinical trial NCT06982755: Acupuncture Versus Compound Diclofenac Sodium for Pain Relief in Non-Traumatic Acute Abdominal
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
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: PHASE1
PHASE2
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
Lead sponsor: The First Affiliated Hospital of Hunan University of Traditional Chinese Medicine
Sponsor class: OTHER
First posted: 2025-05-21
Enrollment: 176
Sex: ALL
Minimum age (years): 16
Maximum age (years): 75
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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.

Eligibility criteria: 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.

Primary outcomes:
measure: Pain response rate
timeFrame: at 10 minutes after analgesia
Secondary outcomes:
measure: The utilization rate of rescue drugs
timeFrame: within 1 hour to 1 day post-analgesia
measure: Expectations with the intervention
timeFrame: baseline
measure: Satisfaction with the intervention
timeFrame: at 1 day after analgesia
measure: Numeric Rating Scale (NRS) score
timeFrame: at 0, 1, 5, 10, 20, 30, and 60 minutes, and at 1 and 3 days post-analgesia
measure: Recurrence rate of pain
timeFrame: at 1 day after analgesia
Other outcomes:
measure: Avatar Incidence of adverse events
timeFrame: through study completion, an average of 3 days
Locations:
Study officials:
affiliation: Hunan University of Traditional Chinese Medicine
name: Zhong Feng, Ph.D.
role: STUDY_DIRECTOR
References: