A Phase 1/2 interventional study of acupuncture and compound diclofenac sodium in Acute Abdominal Pain, Acupuncture Therapy and Acupuncture, sponsored by The First Affiliated Hospital of Hunan University of Traditional Chinese Medicine. Not yet recruiting. Open to participants aged 16 Years to 75 Years. Per ClinicalTrials.gov, last updated 2025-05-21.
Sponsored by The First Affiliated Hospital of Hunan University of Traditional Chinese Medicine · Phase 1/2, Interventional, and Treatment
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.
65 studies on the registry are indexed under Abdomen, Acute; 14 are open to participants now.
This study's planned enrollment of 176 is close to the median of 188 across 26 interventional studies indexed under Abdomen, Acute.
Browse Abdomen, Acute studies →The First Affiliated Hospital of Hunan University of Traditional Chinese Medicine is the lead sponsor of 12 studies on the registry; 2 are open to participants now.
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（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:
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.
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.
Contraindication
A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
acupuncture at Zusanli (ST36)
Procedure: acupuncture · Drug: compound diclofenac sodium · Combination Product: acupuncture combined with compound diclofenac sodium · Combination Product: placebo
intramuscular injection of compound diclofenac sodium injection
Procedure: acupuncture · Drug: compound diclofenac sodium · Combination Product: acupuncture combined with compound diclofenac sodium · Combination Product: placebo
acupuncture at Zusanli (ST36) and intramuscular injection of compound diclofenac sodium injection
Procedure: acupuncture · Drug: compound diclofenac sodium · Combination Product: acupuncture combined with compound diclofenac sodium · Combination Product: placebo
superficial acupuncture at Zusanli (ST36) and intramuscular injection of normal saline
Procedure: acupuncture · Drug: compound diclofenac sodium · Combination Product: acupuncture combined with compound diclofenac sodium · Combination Product: placebo
acupuncture at Zusanli (ST36); sample size: 44
intramuscular injection of compound diclofenac sodium injection; sample size: 44
Also known as: compound Diclofenac Sodium Injection
acupuncture at Zusanli (ST36) and intramuscular injection of compound diclofenac sodium injection; sample size: 44
superficial acupuncture at Zusanli (ST36) and intramuscular injection of normal saline; sample size: 44
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
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.
Time frame: at 1 day after analgesia
Avatar Incidence of adverse events
During the entire treatment period and follow-up period: Adverse events were evaluated immediately after the intervention, at 0, 1, 5, 10, 20, 30, and 60 minutes after the treatment, and during the follow-up periods on the first and third days after the intervention. The frequency of adverse events in each group was recorded, and the proportion of adverse events was calculated.
Time frame: through study completion, an average of 3 days
No study locations are listed for this record.
Start is estimated for Jun 2025; primary completion for Dec 2025, 6 months later.
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The First Affiliated Hospital of Hunan University of Traditional Chinese Medicine