NCT06615765

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

Efficacy and Safety of Two-step Acupuncture Therapy for Symptom Relief in Adults with Mild to Moderate Ulcerative Colitis

• Status: Not Yet Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 64 (estimated)
• Sponsor: Guang'anmen Hospital of China Academy of Chinese Medical Sciences · Academic / Other
• Sex: All
• Age: 18 Years – 70 Years
• Healthy volunteers: Not accepted

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.

Detailed description

Ulcerative colitis (UC) is a chronic inflammatory bowel disease characterized by episodes of symptoms including rectal bleeding, increase stool frequency, and abdominal pain, impacting quality of life significantly. Conventional treatments often come with potential side effects and may not be sufficient. Acupuncture is increasingly recognized for its promising benefits in UC. This study aims to assess the efficacy and safety of acupuncture for symptom relief in mild to moderate UC.This single-center, parallel-arm, randomized, sham-controlled trial will involve 64 patients with UC, randomly assigned in a 1:1 ratio to either the acupuncture or sham acupuncture group. Participants will receive 20 sessions of acupuncture or sham acupuncture over eight weeks. Blinding will be applied to participants, outcome assessors, and statisticians. The primary outcome measure is the change in Patient-Reported Outcome 2 (PRO2) from baseline at week 8. Secondary outcomes include changes from baseline in the following scales: PRO2 at other time points, weekly average Numeric Rating Scale (U-NRS) for bowel urgency, weekly average NRS for abdominal pain (both associated and not associated with bowel movement), the 32-item Inflammatory Bowel Disease Questionnaire (IBDQ-32), Work Productivity and Activity Impairment Questionnaire-Inflammatory Bowel Disease (WPAI-IBD), Pittsburgh Sleep Quality Index (PSQI), and Hospital Anxiety and Depression Scale (HADS). Patient Global Impression of Change (PGIC) will also be assessed as secondary outcomes. Adverse events and additional treatments will be monitored throughout the study. The modified intention-to-treat (mITT) population will include participants who complete baseline assessments and receive at least one treatment session.

Conditions

• Ulcerative Colitis

Interventions

Type	Name	Description
OTHER	Acupuncture	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	Sham acupuncture	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.

Timeline

• Start date: 2024-11-01
• Primary completion: 2026-06-30
• Completion: 2026-10-31
• First posted: 2024-09-27
• Last updated: 2024-09-27