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
试验速览
- 阶段
- 1 期
- 状态
- 尚未招募
- 发起方
- 入组人数
- 176
- 主要终点
- Pain response rate
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
盲法说明
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.
入排标准
- 年龄范围
- 16 Years 至 75 Years（Child, Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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.
排除标准
- •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.
研究组 & 干预措施
acupuncture group
acupuncture at Zusanli (ST36)
干预措施: acupuncture (Procedure)
acupuncture group
acupuncture at Zusanli (ST36)
干预措施: acupuncture combined with compound diclofenac sodium (Combination Product)
acupuncture group
acupuncture at Zusanli (ST36)
干预措施: placebo (Combination Product)
compound diclofenac sodium group
intramuscular injection of compound diclofenac sodium injection
干预措施: acupuncture (Procedure)
compound diclofenac sodium group
intramuscular injection of compound diclofenac sodium injection
干预措施: acupuncture combined with compound diclofenac sodium (Combination Product)
compound diclofenac sodium group
intramuscular injection of compound diclofenac sodium injection
干预措施: placebo (Combination Product)
acupuncture combined with compound diclofenac sodium group
acupuncture at Zusanli (ST36) and intramuscular injection of compound diclofenac sodium injection
干预措施: acupuncture combined with compound diclofenac sodium (Combination Product)
acupuncture combined with compound diclofenac sodium group
acupuncture at Zusanli (ST36) and intramuscular injection of compound diclofenac sodium injection
干预措施: acupuncture (Procedure)
acupuncture combined with compound diclofenac sodium group
acupuncture at Zusanli (ST36) and intramuscular injection of compound diclofenac sodium injection
干预措施: placebo (Combination Product)
placebo group
superficial acupuncture at Zusanli (ST36) and intramuscular injection of normal saline
干预措施: acupuncture (Procedure)
placebo group
superficial acupuncture at Zusanli (ST36) and intramuscular injection of normal saline
干预措施: acupuncture combined with compound diclofenac sodium (Combination Product)
placebo group
superficial acupuncture at Zusanli (ST36) and intramuscular injection of normal saline
干预措施: placebo (Combination Product)
placebo group
superficial acupuncture at Zusanli (ST36) and intramuscular injection of normal saline
干预措施: compound diclofenac sodium (Drug)
acupuncture combined with compound diclofenac sodium group
acupuncture at Zusanli (ST36) and intramuscular injection of compound diclofenac sodium injection
干预措施: compound diclofenac sodium (Drug)
compound diclofenac sodium group
intramuscular injection of compound diclofenac sodium injection
干预措施: compound diclofenac sodium (Drug)
acupuncture group
acupuncture at Zusanli (ST36)
干预措施: compound diclofenac sodium (Drug)
结局指标
主要结局
Pain response rate
时间窗: at 10 minutes after analgesia
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
次要结局
- The utilization rate of rescue drugs(within 1 hour to 1 day post-analgesia)
- Satisfaction with the intervention(at 1 day after analgesia)
- Expectations with the intervention(baseline)
- 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)