Acupuncture for Symptom Relief in Adults with Mild to Moderate Ulcerative Colitis

NCT06615765 | Not Yet Recruiting

• 1 other identifier: 2024-190-KY
• Study Type: interventional
• Target: 64
• Locations: 0 countries
• Sites: N/A

Brief Summary

Ulcerative colitis (UC) is one of the two primary forms of inflammatory bowel disease. This condition is characterized by continuous mucosal inflammation that begins in the rectum and extends proximally throughout the colon. Common intestinal symptoms also include rectal bleeding, increased stool frequency, tenesmus, nocturnal bowel movements, and crampy abdominal pain. Acupuncture has been suggested as a potential intervention to alleviate clinical symptoms of UC. This single-center, parallel-group, two-arm, randomized, sham-controlled trial aims to evaluate the effects and safety of acupuncture for UC.

Conditions

Ulcerative Colitis

Keywords

Acupuncture; Ulcerative colitis; Patient-reported outcome 2; Inflammatory bowel disease; Randomized controlled trial

Outcome Measures

Primary Outcomes (1)

• change from baseline in the PRO2 score

  Data on daily bowel movements and rectal bleeding will be summarized from the stool diaries. The PRO2 score, assessed at weeks 4, 8, 12, 16, 20, 24, 28, and 32, comprises the Stool Frequency (SF) and Rectal Bleeding (RB) subscales of the Mayo score. The SF subscale is rated as follows: 0 (normal stool frequency), 1 (1-2 stools more than normal), 2 (3-4 stools more than normal), and 3 (5 or more stools more than normal). The RB subscale is rated as: 0 (no blood), 1 (streaks of blood less than half the time), 2 (obvious blood most of the time), and 3 (blood alone). The primary outcome is the change from baseline in the PRO2 score at week 8.

  Week 8 after randomization

Secondary Outcomes (11)

• The proportion of patients achieving a ≥ 50% reduction in PRO2 score at weeks 4, 8, 12, 16, 20, 24, 28, and 32.

  Weeks 4, 8, 12, 16, 20, 24, 28, and 32 after randomization.

• The proportion of patients with a PRO2 score of 0

  At weeks 4, 8, 12, 16, 20, 24, 28, and 32 after randomization.

• Changes from baseline in weekly average U-NRS scores

  At weeks 4, 8, 12, 16, 20, 24, 28, and 32 after randomization.

• Changes from baseline in weekly average NRS scores for abdominal pain associated with bowel movements

  At weeks 4, 8, 12, 16, 20, 24, 28, and 32 after randomization.

• Changes from baseline in weekly average NRS scores for abdominal pain not associated with bowel movements

  At weeks 4, 8, 12, 16, 20, 24, 28, and 32 after randomization.

Other Outcomes (1)

• Adverse events

  Up to week 30.

Study Arms (2)

Acupuncture group

EXPERIMENTAL

Acupuncture sessions will use sterile, disposable stainless-steel needles (0.3 mm × 40 mm and 0.3 mm × 75 mm). Each session has two phases: Supine Position: Needles (0.35 mm × 75 mm) are inserted into ST25, ST15, and SP14, reaching the abdominal muscle layer. Needles (0.30 mm × 40 mm) are inserted into CV12, CV4, ST36, ST37, and SP6. Electroacupuncture (EA) at ST25, SP15, and ST36 uses a continuous 5 Hz wave, 0.1 to 2.0 mA. Prone Position: Needles are inserted into BL32, BL33, and BL35 with precise angles and depths. EA at BL32, BL33, and BL35 uses a continuous 5 Hz wave, 2.0 to 6.5 mA. Sessions occur three times a week for the first 4 weeks, then twice a week for weeks 5 to 8, each lasting 40 minutes, totaling 20 sessions.

Other: Acupuncture

Sham acupuncture group

SHAM COMPARATOR

Sterile, disposable stainless-steel needles (0.30 mm × 25 mm) will be used. After skin sterilization, needles will be inserted into the same points as the acupuncture group but to a shallow depth of 2 to 3 mm and lightly manipulated for blinding. Paired alligator clips will be attached to the same points, but the sham EA apparatus will have no current output, though it mimics the active EA apparatus in appearance and sound. Sham sessions will follow the same schedule as the acupuncture group: three times a week for the first 4 weeks and twice a week for weeks 5 to 8, each lasting 40 minutes, totaling 20 sessions.

Other: Sham acupuncture

Interventions

Acupuncture OTHER

Acupuncture sessions will use sterile, disposable stainless-steel needles (0.3 mm × 40 mm and 0.3 mm × 75 mm). Each session has two phases: Supine Position: * Needles (0.35 mm × 75 mm) are inserted into ST25, ST15, and SP14, reaching the abdominal muscle layer. * Needles (0.30 mm × 40 mm) are inserted into CV12, CV4, ST36, ST37, and SP6. * Electroacupuncture (EA) at ST25, SP15, and ST36 uses a continuous 5 Hz wave, 0.1 to 2.0 mA. Prone Position: * Needles are inserted into BL32, BL33, and BL35 with precise angles and depths. * EA at BL32, BL33, and BL35 uses a continuous 5 Hz wave, 2.0 to 6.5 mA. Sessions occur three times a week for the first 4 weeks, then twice a week for weeks 5 to 8, each lasting 40 minutes, totaling 20 sessions.

Acupuncture group

Sham acupuncture OTHER

Sterile, disposable stainless-steel needles (0.30 mm × 25 mm) will be used. After skin sterilization, needles will be inserted into the same points as the acupuncture group but to a shallow depth of 2 to 3 mm and lightly manipulated for blinding. Paired alligator clips will be attached to the same points, but the sham EA apparatus will have no current output, though it mimics the active EA apparatus in appearance and sound. Sham sessions will follow the same schedule as the acupuncture group: three times a week for the first 4 weeks and twice a week for weeks 5 to 8, each lasting 40 minutes, totaling 20 sessions.

Sham acupuncture group

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Eligible participants are those aged 18 to 70 years who meet the diagnostic criteria for mild to moderate UC, have a PRO2 score of ≥ 2 points, and provide written informed consent. Patients currently receiving oral and/or topical 5-aminosalicylic acid (such as mesalamine) may continue their treatment during the study period.

You may not qualify if:

• Participants will be excluded if they meet any of the following criteria:
• Diagnosis of Crohn's disease, intestinal tuberculosis, chronic intestinal infections, or intestinal malignancies.
• Current treatment with corticosteroids, thiopurines, biologics, or oral small molecules.
• Severe skin conditions or infections.
• Presence of severe underlying medical conditions, including but not limited to cardiovascular diseases, hepatobiliary diseases, kidney diseases, hematologic disorders, autoimmune diseases, communicable diseases, severe malnutrition, or malignancies.
• Mental illness, cognitive dysfunction, or language disorders.
• Receipt of acupuncture therapy for UC within the past month.
• Substance abuse issues.
• Pregnancy, plans to become pregnant within the next year, lactation, or being within 12 months postpartum.

Sponsors & Collaborators

• Guang'anmen Hospital of China Academy of Chinese Medical Sciences: lead

Related Publications (1)

• Chen H, Fang J, Liu S, Gao S, Shi H, Ma JZ, Shen X, Wang W, Liu Z. Efficacy and safety of two-step acupuncture therapy for symptom relief in adults with mild to moderate ulcerative colitis: rationale and design of the TSA-UC randomised controlled trial. BMJ Open. 2025 Feb 27;15(2):e094301. doi: 10.1136/bmjopen-2024-094301.

  PMID: 40021194 DERIVED

MeSH Terms

Conditions

Colitis, Ulcerative; Inflammatory Bowel Diseases

Interventions

Acupuncture Therapy

Condition Hierarchy (Ancestors)

Colitis; Gastroenteritis; Gastrointestinal Diseases; Digestive System Diseases; Colonic Diseases; Intestinal Diseases

Intervention Hierarchy (Ancestors)

Complementary Therapies; Therapeutics

Central Study Contacts

He Chen, bachelor of medicine

CONTACT

+86 19927523321; chenhenick@gmail.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Masking Details: Blinding will be maintained for participants, outcome assessors, and statisticians to prevent bias in evaluation. However, the practitioner administering the intervention will not be blinded.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Researcher, Department of Acupuncture, Guang'anmen Hospital, China Academy of Chinese Medical Sciences, Principal Investigator

Study Record Dates

• First Submitted: September 22, 2024
• First Posted: September 27, 2024
• Study Start: November 1, 2024
• Primary Completion (Estimated): June 30, 2026
• Study Completion (Estimated): October 31, 2026
• Last Updated: September 27, 2024

Record last verified: 2024-09

Data Sharing

• IPD Sharing: Will not share