TEAS for Chronic Constipation

Overseen By Andrew Shubov, MD

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: University of California, Los Angeles

Must not be taking: Laxatives

Disqualifiers: Pregnancy, Pacemaker, Hematochezia, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: 3

Duration: 4 weeks

100 Participants Needed

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.

Will I have to stop taking my current medications?

The trial does not specify if you need to stop taking your current medications, but you cannot participate if you've changed your constipation-related medications in the past month or use rescue medications more than once a week.

What data supports the effectiveness of the treatment TEAS for chronic constipation?

Research shows that transcutaneous electrical nerve stimulation (TENS) at acupoints can improve symptoms and increase colonic transit in patients with slow transit constipation. Additionally, transcutaneous electrical acustimulation (TEA) at acupoint ST36 has been found effective for treating chronic constipation, with sustained benefits. ^{1 2 3 4 5}

Is TEAS safe for humans?

Research shows that transcutaneous electrical acupoint stimulation (TEAS) is generally safe for treating conditions like chronic constipation and pain management after surgery. It is a non-invasive treatment, meaning it doesn't involve surgery or entering the body, and studies have not reported significant safety concerns. ^{1 2 3 4 6}

How is the TEAS treatment different from other treatments for chronic constipation?

TEAS (Transcutaneous Electrical Acupoint Stimulation) is unique because it uses electrical stimulation at specific acupuncture points to improve bowel function, which may enhance rectal sensation and autonomic functions, offering a non-drug alternative for managing chronic constipation. ^{1 3 4 5 7}

Research Team

Andrew Shubov, MD

Principal Investigator

University of California, Los Angeles

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.

subjects must have normal serum chemistry and normal thyroid stimulating hormone (TSH) within the past year

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.

You have a pacemaker, implanted cardiac defibrillator, or any other implanted electrical device.

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2 weeks

Phone screening and 1 in-person visit

Baseline Assessment

Participants complete a bowel movement logbook and submit surveys, with HRV measurement and instruction on TEAS pad placement

1 visit

1 in-person visit

Treatment

Participants use TEAS device daily for 30 minutes, track device use and bowel movements, and complete weekly online surveys

4 weeks

Weekly online surveys

Follow-up

Participants return devices and repeat surveys and HRV measurements

1 visit

1 in-person visit

Treatment Details

Interventions

• Sham TEAS
• Transcutaneous Electrical Acupoint Stimulation (TEAS)
• Verum TEAS

Trial Overview 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.

Participant Groups

Group I: TEAS Active Control 1 Intervention

True acupoint locations for placement of TENS unit pads

Group II: Placebo Placebo Group 1 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

Who Is Running the Clinical Trial?

University of California, Los Angeles

Lead Sponsor

Trials

1,594

Recruited

10,430,000+

Findings from Research

Transcutaneous electrical nerve stimulation (TENS) applied at specific acupoints significantly improved symptoms of slow transit constipation (STC) in 39 patients, reducing dyschezia scores and promoting colonic transit over a 2-week treatment period.

The TENS treatment also led to significant reductions in anxiety and depression scores, indicating that it not only helps with constipation but may also improve overall mental well-being in patients.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

[Transcutaneous electrical nerve stimulation improves oppilative symptoms and increases colonic transit in patients with slow transit constipation]. Shi, N., Liu, S., Xie, XP., et al.[2009]

Transcutaneous acupoint electrical stimulation (TEAS) significantly reduced pain levels in women undergoing surgical abortion when applied before the procedure, with lower Visual Analog Scale (VAS) scores compared to a control group.

TEAS not only provided effective pain relief but also resulted in fewer complications like nausea and vomiting, suggesting it could be a beneficial adjunct to standard pain management in surgical abortion.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Transcutaneous acupoint electrical stimulation pain management after surgical abortion: A cohort study. Feng, X., Ye, T., Wang, Z., et al.[2018]

This trial will compare the efficacy of electroacupuncture (EA) and transcutaneous electric nerve stimulation (TENS) in treating functional constipation, involving 102 participants over 8 weeks, with the primary goal of increasing bowel movement frequency.

The study aims to determine if EA is more effective than TENS in improving bowel function and quality of life for individuals with functional constipation, although it acknowledges the limitation of not blinding participants or practitioners.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Efficacy of electroacupuncture compared with transcutaneous electric nerve stimulation for functional constipation: Study protocol for a randomized, controlled trial. Zeng, Y., Zhang, X., Zhou, J., et al.[2021]

In a pilot study involving 70 participants with severe chronic constipation, electroacupuncture (EA) was found to be more effective than transcutaneous electrical stimulation (TES) in increasing the number of complete spontaneous bowel movements (CSBMs) over an 8-week treatment period, with significant improvements observed during follow-up at weeks 20 and 32.

EA also led to a greater reduction in the Patient Assessment of Constipation Quality of Life (PAC-QOL) scores compared to TES, indicating a better overall quality of life for participants receiving EA, although TES remains a noninvasive option for those hesitant about acupuncture.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Efficacy of Electroacupuncture Compared With Transcutaneous Electrical Stimulation for Severe Chronic Constipation: A Randomized Controlled Pilot Trial. Zeng, Y., Chen, F.[2023]

Transcutaneous electrical acustimulation (TEA) at acupoint ST36 significantly increased the number of spontaneous bowel movements and improved constipation symptoms in 44 patients over a 2-week treatment period, with effects lasting for at least 4 weeks after treatment cessation.

TEA treatment enhanced rectal sensitivity and increased vagal activity, suggesting that these mechanisms may contribute to its efficacy in alleviating chronic constipation.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Sustained ameliorating effects and autonomic mechanisms of transcutaneous electrical acustimulation at ST36 in patients with chronic constipation. Zhou, JY., Wang, J., Ning, BF., et al.[2022]

Transcutaneous electrical acupoint stimulation (TEAS) at a frequency of 2/100 Hz significantly reduced intraoperative opioid consumption and improved recovery metrics, such as shorter extubation time and reduced pain scores, in 80 patients undergoing VATS lobectomy.

TEAS is a safe, non-invasive method that not only helps manage anesthesia but also decreases the incidence of postoperative nausea and vomiting (PONV) when applied at 100 Hz, indicating its potential as an effective adjunctive treatment in surgical settings.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Effects of transcutaneous electrical acupoint stimulation at different frequencies on perioperative anesthetic dosage, recovery, complications, and prognosis in video-assisted thoracic surgical lobectomy: a randomized, double-blinded, placebo-controlled trial. Huang, S., Peng, W., Tian, X., et al.[2018]

Transcutaneous electrical acustimulation (TEA) at acupuncture point ST36 significantly increased spontaneous bowel movements in chronic constipation patients, improving their symptoms and quality of life after 2 weeks of treatment compared to sham-TEA.

TEA also enhanced rectal sensation by lowering the thresholds for urge to defecate and maximum tolerable volume, likely through increased parasympathetic activity, indicating a potential mechanism for its effectiveness in treating constipation.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Transcutaneous Electrical Acustimulation Improves Constipation by Enhancing Rectal Sensation in Patients With Functional Constipation and Lack of Rectal Sensation. Xiao, Y., Xu, F., Lin, L., et al.[2023]

References

1. China pubmed.ncbi.nlm.nih.gov

[Transcutaneous electrical nerve stimulation improves oppilative symptoms and increases colonic transit in patients with slow transit constipation]. [2009]

2. United States pubmed.ncbi.nlm.nih.gov

Transcutaneous acupoint electrical stimulation pain management after surgical abortion: A cohort study. [2018]

3. United States pubmed.ncbi.nlm.nih.gov

Efficacy of electroacupuncture compared with transcutaneous electric nerve stimulation for functional constipation: Study protocol for a randomized, controlled trial. [2021]

4. United States pubmed.ncbi.nlm.nih.gov

Efficacy of Electroacupuncture Compared With Transcutaneous Electrical Stimulation for Severe Chronic Constipation: A Randomized Controlled Pilot Trial. [2023]

5. Switzerland pubmed.ncbi.nlm.nih.gov

Sustained ameliorating effects and autonomic mechanisms of transcutaneous electrical acustimulation at ST36 in patients with chronic constipation. [2022]

6. Japan pubmed.ncbi.nlm.nih.gov

Effects of transcutaneous electrical acupoint stimulation at different frequencies on perioperative anesthetic dosage, recovery, complications, and prognosis in video-assisted thoracic surgical lobectomy: a randomized, double-blinded, placebo-controlled trial. [2018]

7. United States pubmed.ncbi.nlm.nih.gov

Transcutaneous Electrical Acustimulation Improves Constipation by Enhancing Rectal Sensation in Patients With Functional Constipation and Lack of Rectal Sensation. [2023]