Acute Abdominal PainPhase 1/2ACU-NTAANCT06982755
Acupuncture Versus Compound Diclofenac Sodium for Pain Relief in Non-Traumatic Acute Abdominal
A Phase 1/2 study testing acupuncture, compound diclofenac sodium and acupuncture combined with compound diclofenac sodium in people with Acute Abdominal Pain and Acupuncture Therapy, run by The First Affiliated Hospital of Hunan University of Traditional Chinese Medicine.
Trial 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. Read more about this study
- Who is it for?
- Ages 16 to 75 years
- Conditions the study is for
- Acute Abdominal Pain, Acupuncture Therapy, Acupuncture
- What is being tested?
- acupuncture, compound diclofenac sodium and acupuncture combined with compound diclofenac sodium
- Type of treatment
- Injection or infusion, Surgery or procedure
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 176 participants
- Where
- No sites listed yet
- Study dates
- 1 Jun 2025to 31 Dec 2026
- Phase
- Phase 1/2
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 16 to 75 years
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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;
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- 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.
Trial locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
About this study
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
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.
Read the 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.
- Conditions
- Acute Abdominal Pain, Acupuncture Therapy, Acupuncture, Opioids
- Being tested
- acupuncture, compound diclofenac sodium, acupuncture combined with compound diclofenac sodium, placebo
- 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
- Medical subject headings
- Abdomen, Acute
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
acupunctureProcedure or surgery
acupuncture at Zusanli (ST36); sample size: 44
compound diclofenac sodiumDrug
Also called compound Diclofenac Sodium Injection
intramuscular injection of compound diclofenac sodium injection; sample size: 44
acupuncture combined with compound diclofenac sodiumCombination product
acupuncture at Zusanli (ST36) and intramuscular injection of compound diclofenac sodium injection; sample size: 44
placeboCombination product
superficial acupuncture at Zusanli (ST36) and intramuscular injection of normal saline; sample size: 44
| Study group | Role | What they receive |
|---|---|---|
| acupuncture group | Active comparator | acupuncture at Zusanli (ST36) Receives: Procedure: acupuncture; Drug: compound diclofenac sodium; Combination Product: acupuncture combined with compound diclofenac sodium; Combination Product: placebo |
| compound diclofenac sodium group | Active comparator | intramuscular injection of compound diclofenac sodium injection Receives: Procedure: acupuncture; Drug: compound diclofenac sodium; Combination Product: acupuncture combined with compound diclofenac sodium; Combination Product: placebo |
| acupuncture combined with compound diclofenac sodium group | Experimental | acupuncture at Zusanli (ST36) and intramuscular injection of compound diclofenac sodium injection Receives: Procedure: acupuncture; Drug: compound diclofenac sodium; Combination Product: acupuncture combined with compound diclofenac sodium; Combination Product: placebo |
| placebo group | Placebo comparator | superficial acupuncture at Zusanli (ST36) and intramuscular injection of normal saline Receives: Procedure: acupuncture; Drug: compound diclofenac sodium; Combination Product: acupuncture combined with compound diclofenac sodium; Combination Product: placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: at 10 minutes after analgesia
Secondary outcomes (5)
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).
Measured: 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.
Measured: 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.
Measured: at 1 day after analgesia
Numeric Rating Scale (NRS) score
Numeric Rating Scale
Measured: 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.
Measured: at 1 day after analgesia
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 May 2025
- Study start1 Jun 2025 (estimated)
- Primary completion31 Dec 2025 (estimated)
- Study completion31 Dec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Acute Abdominal PainStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1/2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 176 participants (estimated)
Sponsor and investigators
- Lead sponsor
- The First Affiliated Hospital of Hunan University of Traditional Chinese Medicine
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Zhong Feng, Ph.D., Study director, The First Affiliated Hospital of Hunan University of Traditional Chinese Medicine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06982755
- Sponsor's protocol ID
- A2024021
- Acronym
- ACU-NTAA
- Status last verified
- May 2025
- First submitted
- 24 Apr 2025
- Last updated
- 21 May 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 21 May 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT06982755
- Acronym / sponsor ID
- ACU-NTAA / A2024021
- 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
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 176 participants (estimated)
- Lead sponsor
- The First Affiliated Hospital of Hunan University of Traditional Chinese MedicineUniversity, hospital or other
- Study start
- 1 Jun 2025 (estimated)
- Primary completion
- 31 Dec 2025 (estimated)
- Study completion
- 31 Dec 2026 (estimated)
- First posted
- 21 May 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| acupuncture group | Active comparator | Procedure: acupuncture, Drug: compound diclofenac sodium, Combination Product: acupuncture combined with compound diclofenac sodium, Combination Product: placeboacupuncture at Zusanli (ST36) |
| compound diclofenac sodium group | Active comparator | Procedure: acupuncture, Drug: compound diclofenac sodium, Combination Product: acupuncture combined with compound diclofenac sodium, Combination Product: placebointramuscular injection of compound diclofenac sodium injection |
| acupuncture combined with compound diclofenac sodium group | Experimental | Procedure: acupuncture, Drug: compound diclofenac sodium, Combination Product: acupuncture combined with compound diclofenac sodium, Combination Product: placeboacupuncture at Zusanli (ST36) and intramuscular injection of compound diclofenac sodium injection |
| placebo group | Placebo comparator | Procedure: acupuncture, Drug: compound diclofenac sodium, Combination Product: acupuncture combined with compound diclofenac sodium, Combination Product: placebosuperficial acupuncture at Zusanli (ST36) and intramuscular injection of normal saline |
Who may qualify
- Ages
- 16 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (3 listed)
- 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.
Key exclusion criteria (16 listed)
- 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;
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| acupunctureacupuncture at Zusanli (ST36); sample size: 44 | Procedure or surgery | acupuncture combined with compound diclofenac sodium group, acupuncture group, compound diclofenac sodium group, placebo group |
| compound diclofenac sodiumAlso: compound Diclofenac Sodium Injectionintramuscular injection of compound diclofenac sodium injection; sample size: 44 | Drug | acupuncture combined with compound diclofenac sodium group, acupuncture group, compound diclofenac sodium group, placebo group |
| acupuncture combined with compound diclofenac sodiumacupuncture at Zusanli (ST36) and intramuscular injection of compound diclofenac sodium injection; sample size: 44 | Combination product | acupuncture combined with compound diclofenac sodium group, acupuncture group, compound diclofenac sodium group, placebo group |
| placebosuperficial acupuncture at Zusanli (ST36) and intramuscular injection of normal saline; sample size: 44 | Combination product | acupuncture combined with compound diclofenac sodium group, acupuncture group, compound diclofenac sodium group, placebo group |
Primary outcome
Pain response rate
Time frame: 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
5 secondary outcomes
The utilization rate of rescue drugs
Time frame: within 1 hour to 1 day post-analgesia
Expectations with the intervention
Time frame: baseline
Satisfaction with the intervention
Time frame: at 1 day after analgesia
Numeric Rating Scale (NRS) score
Time frame: at 0, 1, 5, 10, 20, 30, and 60 minutes, and at 1 and 3 days post-analgesia
Recurrence rate of pain
Time frame: at 1 day after analgesia
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 May 2025.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Zhong Feng, Ph.D. study director
The First Affiliated Hospital of Hunan University of Traditional Chinese Medicine
Questions about this trial
What is this clinical trial studying?
A Phase 1/2 study testing acupuncture, compound diclofenac sodium and acupuncture combined with compound diclofenac sodium in people with Acute Abdominal Pain and Acupuncture Therapy, run by The First Affiliated Hospital of Hunan University of Traditional Chinese Medicine.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 16 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 21 May 2025. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this combined phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Zhong Feng, Ph.D. (18711009633, ahtcmzhong@163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Pain response rate (time frame: at 10 minutes after analgesia). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 21 May 2025.