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

Phase 2Not Yet RecruitingNCT06982755

The First Affiliated Hospital of Hunan University of Traditional Chinese Medicine176 enrolled

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.

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Enrollment

176

Conditions

Acute Abdominal Pain Acupuncture Therapy Acupuncture

Eligibility

Sex: ALLMin age: 16 YearsMax age: 75 Years

Medical Language ↔ Plain English

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.

Outcomes

Primary Outcomes

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

Time frame: at 10 minutes after analgesia

Secondary Outcomes

The utilization rate of rescue drugs

If the subject still experiences intolerable pain (NRS ≥ 4) after 1 hour of treatment or following supplemental treatment, additional analgesic medications such as Rotundine or Dezocine shall be administered. Furthermore, subjects who still exhibit "severe pain" after 1 hour of treatment will be given rescue analgesic medication: Pethidine Hydrochloride Injection, 25 mg, intramuscularly (to be prescribed by a supervising physician with the qualifications to prescribe narcotic drugs).

Time frame: within 1 hour to 1 day post-analgesia

Expectations with the intervention

In this study, a Likert scale was utilized to construct a specialized questionnaire aimed at assessing patients' expectations of the intervention. The questionnaire consists of four items designed to evaluate patients' anticipations regarding the intervention's efficacy in alleviating symptoms, its onset of action, potential side effects, and its impact on quality of life. Each item is scored on a five-point scale, ranging from 1 (strongly disagree) to 5 (strongly agree). At baseline, the ratings for each item were determined according to the personal expectations of the patients. To provide a comprehensive reflection of patients' overall expectations of the intervention, each item is assigned equal weight in the total score calculation. The scores of the four items are summed to yield a total score, which quantifies patients' overall expectations of the intervention.

Time frame: baseline

Satisfaction with the intervention

In this study, a Likert scale was employed to develop a specialized questionnaire designed to assess patient satisfaction with the intervention. The questionnaire comprehensively evaluates patient satisfaction across multiple dimensions, including satisfaction with the treatment process, experience of side effects, and overall satisfaction. Each dimension is rated on a five-point scale, ranging from 1 (strongly disagree) to 5 (strongly agree). The items in the questionnaire were rated by patients based on their actual experiences on the first day after the intervention. To provide a comprehensive reflection of patients' overall satisfaction with the intervention, each item carries equal weight in the total score calculation. The scores of all items are summed to yield a total score, which quantifies the patients' overall satisfaction with the intervention.

Time frame: at 1 day after analgesia

Numeric Rating Scale (NRS) score

Numeric Rating Scale

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

Recurrence rate of pain

Recurrence rate of pain within 1 day in the four groups: NRS score ≤2 after the initial intervention pain recurrence within 1 day and occurrence of NRS score ≥4.