Efficacy Classification Prediction of the Effects of Acupuncture on Abdominal Pain in Patients With Crohn's Disease

NCT06352164 | Completed

• 1 other identifier: ZYS2024-03
• Study Type: interventional
• Target: 55
• Locations: 1 country
• Sites: 1

Brief Summary

Machine learning algorithms are applied to discover gut flora markers that predict the clinical efficacy of acupuncture, so as to screen the appropriate population for acupuncture and optimise the allocation of healthcare resources.

Conditions

Crohn Disease

Keywords

Crohn Disease; Intestinal flora; Abdominal pain; Machine learning

Outcome Measures

Primary Outcomes (1)

• Characterisation of gut microflora strains predictive of acupuncture efficacy

  Application of machine learning algorithms to discover gut microbial markers (Characterisation of intestinal flora strains) predicting clinical efficacy of acupuncture to screen for appropriate acupuncture populations. Criteria for judging the efficacy of acupuncture: At 12 weeks, patients had complete remission of abdominal pain ( VAS score or frequency of abdominal pain per week = 0) or remission of abdominal pain ( the reduction of VAS score or the frequency of abdominal pain ≥ 3 compare with baseline) were considered effective. Otherwise, it was considered ineffective. Visual Analogue Scale(VAS score):The maximum score is 0, and the minimum score is 10.Higher scores represent a greater degree of abdominal pain and higher scores mean a worse outcome. Frequency of abdominal pain：The maximum score is 0, and the minimum score is 7. Higher scores represent a greater degree of abdominal pain and higher scores mean a worse outcome.

  Week 12

Study Arms (1)

Acupuncture group

EXPERIMENTAL

Subjects receiving acupuncture and moxibustion treatment.

Other: Acupuncture treatment

Interventions

Acupuncture treatment OTHER

The investigators selected acupoints including Zhongwan (CV12) and bilateral Shangjuxu (ST37), Sanyinjiao (SP6), Gongsun (SP4), Taichong (LR3), Taixi (KI3), Hegu (LI4), and Quchi (LI11)17 according to the World Health Organization standard. Single-use 0.30×40 mm or 0.30×25 mm acupuncture needles (Hwato, Suzhou, China) were vertically inserted into each acupoint to 20-30 mm depth to obtain a deqi sensation (a soreness, distention, numbness or heaviness sensation). Bilateral Zusanli (ST36) and Tianshu (ST25) were selected for moxibustion. Pure moxa sticks (diameter: 2.8 cm; Hanyi, Nanyang, China) were ignited and fixed on a moxibustion stand at a distance of 3-5 cm to the surface of acupoints. The temperature of skin surface at the acupoints was maintained at 43 ± 1°C and monitored with a miniature infrared thermometer (Fluke 62, Fluke Corporation, Everett, WA, USA). Acupuncture and moxibustion were concomitantly performed for 30 min.

Acupuncture group

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• aged 18-75, no gender limit;
• disease in mild and moderate active period: 150≤CDAI\<450 and meet at least one of the following: Serum C-reactive protein level≥5mg/L, Fecal calprotectin concentration≥250μg/g or endoscopic examination shows ulcers. remission period: CDAI \<150 and meet at least one of the following: Serum C-reactive protein level\<5 mg/L, Fecal calprotectin concentration \<250μg/g or endoscopic examination shows no ulcer;
• patients were not taking medication or were only taking one or more of the following drugs: mesalazine (≤4g/d and mesalazine was used for at least 1 month), prednisone (≤15mg/d and prednisone was used for at least 1 month) and / or azathioprine (≤1mg/kg/d and azathioprine was used for at least 3 month);
• those who have not used biologics within 3 months before entering the study;
• those who have never experienced acupuncture;
• those who understand and agree to participate in this study and sign the informed consent form.

You may not qualify if:

• patients who are recently pregnant or in pregnancy or lactation;
• patients with serious organic diseases;
• patients diagnosed as psychosis;
• patients who suffer from multiple diseases and need to take other drugs for a long time, and may affect the observation of the efficacy of this trial;
• severe skin diseases (such as erythema nodosum, pyoderma gangrenosum, etc.), eye diseases (such as iritis, uveitis, etc.), thromboembolic diseases and other serious extraintestinal manifestations;
• there are serious intestinal fistula, abdominal abscess, intestinal stenosis and obstruction, perianal abscess, gastrointestinal hemorrhage, intestinal perforation and other complications;
• patients with short bowel syndrome who have undergone abdominal or gastrointestinal surgery in the past half a year;
• there are skin diseases or defects in the selected area of acupuncture and moxibustion that cannot be performed.

Sponsors & Collaborators

• Shanghai Institute of Acupuncture, Moxibustion and Meridian: lead

Study Sites (1)

Shanghai Institute of Acupuncture, Moxibustion and Meridian

Shanghai, 200000, China

Location

MeSH Terms

Conditions

Crohn Disease; Abdominal Pain

Interventions

Acupuncture Therapy

Condition Hierarchy (Ancestors)

Inflammatory Bowel Diseases; Gastroenteritis; Gastrointestinal Diseases; Digestive System Diseases; Intestinal Diseases; Pain; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Signs and Symptoms, Digestive

Intervention Hierarchy (Ancestors)

Complementary Therapies; Therapeutics

Study Officials

• Wu Huangan, PhD,MD

  Shanghai Institute of Acupuncture, Moxibustion and Meridian

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: SCREENING
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 2, 2024
• First Posted: April 8, 2024
• Study Start: March 1, 2015
• Primary Completion: December 31, 2023
• Study Completion: March 31, 2024
• Last Updated: April 9, 2024

Record last verified: 2024-03

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)