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

Официальное название

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

Обзор

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.

Подробное описание

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.

Вмешательства

• Процедура acupuncture
  acupuncture at Zusanli (ST36); sample size: 44
• Препарат compound diclofenac sodium
  intramuscular injection of compound diclofenac sodium injection; sample size: 44
• Комбинированный продукт acupuncture combined with compound diclofenac sodium
  acupuncture at Zusanli (ST36) and intramuscular injection of compound diclofenac sodium injection; sample size: 44
• Комбинированный продукт placebo
  superficial acupuncture at Zusanli (ST36) and intramuscular injection of normal saline; sample size: 44

Первичные конечные точки

• Pain response rate [Срок оценки: at 10 minutes after analgesia]

Вторичные конечные точки (5)

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

Критерии участия

Критерии включения

• 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.

Критерии исключения

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.

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Рандомизированное

Модель

Параллельные группы

Маскирование

Открытое

Основная цель

Лечение

Центры проведения

Список центров уточняется — проверьте первичный протокол.

Идентификаторы

NCT: NCT06982755 · A2024021

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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