Trial Summary
What is the purpose of this trial?Transcutaneous electrical acupoint stimulation (TEAS) is an emerging technology for non-invasive neuromodulation that has broad potential implications and warrants further study. The investigators' clinical experience from the University of California, Los Angeles (UCLA) Center for East-West Medicine (CEWM) has also demonstrated that TEAS can be used as an effective self-care tool for patients with chronic illness who do not have the time or resources for frequent acupuncture treatments. Chronic constipation is the chosen area of study because of the large population with a substantial impairment in health-related quality of life and work productivity. The investigators have recently completed a randomized controlled trial (RCT) demonstrating the benefit of perineal self-acupressure on quality of life measurements in this population, which supports investigation into other acupuncture-based self-care interventions. Given these findings, the investigators hypothesize that home patient-administered TEAS can provide measurable improvements in both symptom severity and health related quality of life.
What safety data exists for TEAS in treating chronic constipation?The available research indicates that transcutaneous electrical acupoint stimulation (TEAS) and related treatments like transcutaneous electrical nerve stimulation (TENS) are considered safe for treating conditions such as functional constipation and severe chronic constipation. Studies have shown that these therapies are effective and safe, although direct comparisons between different methods like electroacupuncture and TEAS are limited.12346
Do I need to stop my current medications for the trial?The trial protocol does not specify if you need to stop your current medications, but you cannot participate if you've changed constipation-related medications in the past month or use rescue medication more than once a week.
Is Transcutaneous Electrical Acupoint Stimulation (TEAS) a promising treatment for chronic constipation?Yes, TEAS is a promising treatment for chronic constipation. It has been shown to improve symptoms by enhancing rectal sensation and increasing the movement of the colon. Studies suggest that it has sustained positive effects and works by stimulating specific points on the body, which can help manage constipation effectively.13456
What data supports the idea that TEAS for Chronic Constipation is an effective treatment?The available research shows that transcutaneous electrical nerve stimulation (TENS) at acupoints can improve symptoms in patients with slow transit constipation. Additionally, studies comparing electroacupuncture and transcutaneous electrical stimulation (TES) indicate that both are safe and effective for treating severe chronic constipation. Another study found that transcutaneous electrical acustimulation (TEA) can improve constipation by enhancing rectal sensation in patients with functional constipation. These findings suggest that TEAS can be an effective treatment for chronic constipation.12345
Eligibility Criteria
This trial is for adults over 18 with chronic constipation, meeting specific criteria like straining or hard stools during bowel movements. They must not have numbness in certain areas, bladder issues, recent weight loss, or use of frequent laxatives. Participants need normal blood tests and can't have a pacemaker or similar devices.Inclusion Criteria
I often feel like I haven't fully emptied my bowels.
I often feel blocked or obstructed when going to the bathroom.
I can feel normally where the treatment pads will be placed on my lower back and knees.
I am 18 years old or older.
I have less than three bowel movements a week.
I often strain during more than a quarter of my bowel movements.
I often have hard or lumpy stools.
I use manual methods to help with over 25% of my bowel movements.
Exclusion Criteria
I have experienced new numbness, pain, or dysfunction in my lower body this year.
I use medication to help with bowel movements more than once a week.
I have started experiencing blood in my stool since my last doctor's visit.
I have lost 10% of my weight in the last 6 months.
Treatment Details
The study is testing TEAS—a non-invasive technique stimulating acupoints electrically—as a self-care treatment for chronic constipation. It compares real TEAS to sham (fake) TEAS to see if it improves symptoms and quality of life.
2Treatment groups
Active Control
Placebo Group
Group I: TEASActive Control1 Intervention
True acupoint locations for placement of TENS unit pads
Group II: PlaceboPlacebo Group1 Intervention
non-acupoint locations for placement of TENS unit pads
Transcutaneous Electrical Acupoint Stimulation (TEAS) is already approved in United States, European Union, China for the following indications:
🇺🇸 Approved in United States as Transcutaneous Electrical Acupoint Stimulation (TEAS) for:
- Chronic Constipation
- Pain Management
- Neuromodulation
🇪🇺 Approved in European Union as Transcutaneous Electrical Acupoint Stimulation (TEAS) for:
- Chronic Constipation
- Pain Relief
- Neurological Disorders
🇨🇳 Approved in China as Transcutaneous Electrical Acupoint Stimulation (TEAS) for:
- Chronic Constipation
- Pain Management
- Digestive Disorders
Find a clinic near you
Research locations nearbySelect from list below to view details:
University of California, Los AngelesLos Angeles, CA
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Who is running the clinical trial?
University of California, Los AngelesLead Sponsor
References
[Transcutaneous electrical nerve stimulation improves oppilative symptoms and increases colonic transit in patients with slow transit constipation]. [2009]To evaluate the therapeutic value of transcutaneous electrical nerve stimulation (TENS) at acupoints in slow transit constipation (STC).
Transcutaneous acupoint electrical stimulation pain management after surgical abortion: A cohort study. [2018]Transcutaneous acupoint electrical stimulation (TEAS) is a standard therapy for painful conditions. This study evaluated pain-relieving effects of treatment with TEAS before and after surgical abortion.
Efficacy of electroacupuncture compared with transcutaneous electric nerve stimulation for functional constipation: Study protocol for a randomized, controlled trial. [2021]To treat functional constipation, both electroacupuncture (EA) therapy and transcutaneous electric nerve stimulation (TENS) are safe and effective. However, no head-to-head comparison trial has been conducted. This trial compares the efficacy of electroacupuncture relative to transcutaneous electric nerve stimulation for functional constipation.
Efficacy of Electroacupuncture Compared With Transcutaneous Electrical Stimulation for Severe Chronic Constipation: A Randomized Controlled Pilot Trial. [2023]To treat severe chronic constipation, both electroacupuncture (EA) therapy and transcutaneous electrical stimulation (TES) are safe and effective, but there is a lack of comparison between the 2 treatments. We sought to compare the therapeutic effect of EA relative to TES for the treatment of severe chronic constipation.
Transcutaneous Electrical Acustimulation Improves Constipation by Enhancing Rectal Sensation in Patients With Functional Constipation and Lack of Rectal Sensation. [2023]Reduced rectal sensation is involved in the pathophysiology of constipation. The aim of this study was to investigate the effects of transcutaneous electrical acustimulation (TEA) at acupuncture point ST36 on constipation and rectal sensation as well as autonomic functions in patients with constipation and reduced rectal sensation.
Sustained ameliorating effects and autonomic mechanisms of transcutaneous electrical acustimulation at ST36 in patients with chronic constipation. [2022]The treatment of chronic constipation is still a great challenge in clinical practice. This study aimed to determine the efficacy and sustained effects of transcutaneous electrical acustimulation (TEA) at acupoint ST36 on the treatment of chronic constipation and explore possible underlying mechanisms.