Acupuncture for Irritable Bowel Syndrome Patients

NCT04387383 | Unknown DMC

• 1 other identifier: HKBU AcupIBS
• Study Type: interventional
• Target: 120
• Locations: 1 country
• Sites: 1

Brief Summary

In this study, a 14-week, single blinded, randomized controlled clinical trial will be conducted to determine whether acupuncture could have significant benefits than sham acupuncture for IBS.

Conditions

Irritable Bowel Syndrome

Outcome Measures

Primary Outcomes (5)

• Change on IBS-symptom severity scale

  Value from 0-500. The higher the score, the more severe the symptoms. When there is lowering of the sore between baseline and treatments, it indicates clinical improvement.

  0,8,14 weeks

• Change on Hamilton Depression Rating Scale (HAMD-17)

  Value from 0-57. Scoring 8-16: mild depression, 17-23: moderate depression, over 24: severe depression. When there is lowering of the sore between baseline and treatments, it indicates improvement on depressive symptoms.

  0,8,14 weeks

• Change on Clinical Global Impression-severity (CGI-S)

  Rating from 1-7, the higher rate indicates more severe of the mental problem. The subject is rated by researcher from his clinical experience. When there is lowering of the rating between baseline and treatments, it indicates improvement.

  0,8,14 weeks

• Change on Self-Rating Depression Scale (SDS)

  Value from 20-80. Scoring 50-69: depression, over 70: severe depression. When there is lowering of the sore between baseline and treatments, it indicates improvement.

  0,8,14 weeks

• Change on IBS Quality of Life (IBS-QoL)

  Value from 35-170. The higher the score, the lower the quality of life. When there is lowering of the sore between baseline and treatments, it indicates improvement.

  0,8,14 weeks

Study Arms (2)

Acupuncture group

EXPERIMENTAL

Electro-acupuncture will be conducted for 2 sessions per week over 6 consecutive weeks. Disposable acupuncture needles (0.30 mm in diameter and 25-40 mm in length) are inserted at a depth of 10-30 mm obliquely into scalp acupuncture points (Baihui, Toulinqi) or straightly into body acupuncture points (Taichong, Zhangmen, Sanyinjiao, Zhongwan, Guanyuan, Tianshu, Zusanli). Electroacupuncture will be applied to the abdominal points at fast and dispersed waves through electric needle stimulator (ES-160 6-Channel Programmable Electro-acupuncture) for 30 min. The intensity is adjusted to a level at which patients feel comfortable.

Device: Acupuncture

sham-acupuncture group

PLACEBO COMPARATOR

Sham-acupuncture will be conducted for 2 sessions per week over 6 consecutive weeks. Disposable acupuncture needles (0.30 mm in diameter and 25-40 mm in length) are inserted at the same way as in the acupuncture group but on sham-acupuncture points (Sham-Baihui, Sham-Toulinqi, Sham-Taichong, Sham-Zhangmen, Sham-Sanyinjiao, Sham-Zhongwan, Sham-Guanyuan, Sham-Tianshu, Sham-Zusanli). The sham points are non-acupuncture points nor located on meridians

Device: Sham-acupuncture

Interventions

Acupuncture DEVICE

Disposable acupuncture needles (0.30 mm in diameter and 25-40 mm in length) are inserted at a depth of 10-30 mm obliquely into scalp acupuncture points (Baihui, Toulinqi) or straightly into body acupuncture points (Taichong, Zhangmen, Sanyinjiao, Zhongwan, Guanyuan, Tianshu, Zusanli). Electroacupuncture will be applied to the abdominal points at fast and dispersed waves through electric needle stimulator (ES-160 6-Channel Programmable Electro-acupuncture) for 30 min. The intensity is adjusted to a level at which patients feel comfortable.

Acupuncture group

Sham-acupuncture DEVICE

Disposable acupuncture needles (0.30 mm in diameter and 25-40 mm in length) are inserted at the same way as in the acupuncture group but on sham-acupuncture points (Sham-Baihui, Sham-Toulinqi, Sham-Taichong, Sham-Zhangmen, Sham-Sanyinjiao, Sham-Zhongwan, Sham-Guanyuan, Sham-Tianshu, Sham-Zusanli). The sham points are non-acupuncture points nor located on meridians

sham-acupuncture group

Eligibility Criteria

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

You may qualify if:

• Fulfillment of the Rome IV criteria for IBS
• IBS Symptom Severity Scale (IBS-SSS) \> 75 points (a range of 0-500 points of VAS on five questions) at baseline and during the 2-week run-in period
• Written informed consent.

You may not qualify if:

• Pregnancy or breast-feeding
• Medical history of inflammatory bowel diseases, carbohydrate malabsorption, hormonal disorder, known allergies to food additives, and/or any other serious diseases
• Unstable medical conditions
• Unstable mental condition or with history of mental illness
• Patients who have received acupuncture treatment in last three months, or took concomitant medication with affect gastrointestinal motility or visceral sensation, such as antidiarrheal agent, antidepressant, narcotic analgesic, and anticholinergic
• Alcoholism or drug abuse in past 1 year
• Having needle phobia

Sponsors & Collaborators

• Hong Kong Baptist University: lead

Study Sites (1)

Linda Zhong

Kowloon Tong, Kowloon, Hong Kong

RECRUITING

Related Publications (1)

• Zhong LLD, Lam TF, Yang W, Zheng Y, Lyu Z, Bian Z. Electro-acupuncture for irritable bowel syndrome patients: study protocol for a single-blinded randomized sham-controlled clinical trial. Trials. 2021 Sep 15;22(1):619. doi: 10.1186/s13063-021-05563-4.

  PMID: 34526079 DERIVED

MeSH Terms

Conditions

Irritable Bowel Syndrome

Interventions

Acupuncture Therapy

Condition Hierarchy (Ancestors)

Colonic Diseases, Functional; Colonic Diseases; Intestinal Diseases; Gastrointestinal Diseases; Digestive System Diseases

Intervention Hierarchy (Ancestors)

Complementary Therapies; Therapeutics

Study Officials

• Zhaoxiang Bian, MD., Ph.D

  Hong Kong Chinese Medicine Clinical Study Centre

  STUDY DIRECTOR

Central Study Contacts

Linda Zhong, MD., Ph.D

CONTACT

852-34116523; ldzhong0305@gmail.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Masking Details: Subjects of both groups will be randomly assigned to receive either electro-acupuncture or control (sham) treatment. For randomization, simple, complete non-sequential random numbers will be generated in advance by a computer program in a block of four, and kept by the principal investigator. After a patient's eligibility is confirmed, a randomization number which corresponds to the group allocation will be provided to the acupuncturist by the PI. This arrangement will ensure that the clinical assessor and participants are blinded to the allocation.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor

Model Details: single-blinded, randomized, sham-controlled clinical trial

Study Record Dates

• First Submitted: May 3, 2020
• First Posted: May 13, 2020
• Study Start: May 18, 2020
• Primary Completion: December 1, 2021
• Study Completion: December 1, 2021
• Last Updated: July 20, 2021

Record last verified: 2021-07

Locations

HK (1)