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

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial explores the use of transcutaneous electrical acupoint stimulation (TEAS), a non-invasive technique, to improve symptoms and quality of life for individuals with chronic constipation. Participants will use the TEAS device on either specific acupoints or non-acupoint areas to determine any difference in effectiveness. This study is suitable for those who have fewer than three spontaneous bowel movements a week and often experience symptoms like straining or hard stools. As an unphased trial, it offers participants the chance to contribute to innovative research that could enhance treatment options for chronic constipation.

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 prior data suggests that this method is safe for treating chronic constipation?

Research has shown that Transcutaneous Electrical Acupoint Stimulation (TEAS) is generally well-tolerated. One study that examined TEAS for post-surgery pain found it safe, with few side effects. Another review highlighted its effectiveness in improving digestion, such as easing constipation. Additionally, a study found that TEAS effectively and safely reduced constipation in cancer patients undergoing chemotherapy.

These findings suggest that TEAS might be a safe option for those considering treatment for chronic constipation. Overall, the evidence indicates that TEAS could be a promising and safe way to improve this condition without invasive methods. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about Transcutaneous Electrical Acupoint Stimulation (TEAS) for chronic constipation because it offers a non-invasive alternative to traditional treatments like laxatives and fiber supplements. Unlike these standard options, TEAS uses electrical stimulation at specific acupoints to potentially regulate bowel movements naturally. This method might provide relief without the gastrointestinal side effects commonly associated with medications, making it a promising option for those seeking a more holistic approach. Additionally, the placebo arm using non-acupoint locations helps demonstrate the specific effectiveness of acupoint stimulation, offering insights into how targeted electrical stimulation can impact digestive health.

What evidence suggests that TEAS might be an effective treatment for chronic constipation?

This trial will compare Transcutaneous Electrical Acupoint Stimulation (TEAS) with a placebo treatment. Studies have shown that TEAS can improve chronic constipation by enhancing rectal sensation and stimulating the part of the nervous system that aids digestion. One study found that a similar treatment, electroacupuncture, improved the long-term quality of life for people with constipation. Additionally, TEAS effectively relieved constipation in cancer patients undergoing chemotherapy, proving it to be a practical and safe approach. These findings suggest that TEAS may offer meaningful improvement in symptoms and quality of life for those with chronic constipation. ^{1 5 6 7 8}

Who Is on the Research Team?

Andrew Shubov, MD

Principal Investigator

University of California, Los Angeles

Are You a Good Fit for This Trial?

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

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

I have had specific symptoms for at least 12 weeks in the last year.

I often feel like I haven't fully emptied my bowels.

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 for a Trial Participant

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

What Are the Treatments Tested in This Trial?

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.

How Is the Trial Designed?

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+

Published Research Related to This Trial

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 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]

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]

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]

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 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]

Citations

1. clinicaltrials.gov clinicaltrials.gov/study/NCT03243955

Transcutaneous Electrical Acupoint Stimulation (TEAS) for ... 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 ...

2. pubmed.ncbi.nlm.nih.gov pubmed.ncbi.nlm.nih.gov/34907924/

Efficacy of Electroacupuncture Compared With ... For the treatment of severe chronic constipation, EA performed better than TES in long-term follow-up and improving the quality of life.

3. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC9720110/

Sustained ameliorating effects and autonomic mechanisms ... Previous studies have demonstrated a favorable effect of acupuncture on the treatment of chronic constipation (Liu et al., 2016). Currently, ...

4. journals.lww.com journals.lww.com/ctg/fulltext/2022/05000/transcutaneous_electrical_acustimulation_improves.12.aspx

Transcutaneous Electrical Acustimulation Improves... TEA at ST36 improves chronic constipation by enhancing rectal sensation possibly mediated by the reinforcement of parasympathetic activity.

5. sciencedirect.com sciencedirect.com/science/article/pii/S2347562521000627

Transcutaneous Acupoint Electrical Stimulation on ... TAES was effective for alleviating constipation in NSCLC patients receiving chemotherapy and was a safe and practical nursing intervention.

6. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC9023215/

Efficacy and Safety of Transcutaneous Electrical Acupoint ... This meta-analysis aims to evaluate the effectiveness and safety of transcutaneous electrical acupoint stimulation (TEAS) in treating post-operative pain.

7. sciencedirect.com sciencedirect.com/science/article/pii/S1003525724000795

Transcutaneous electrical acupoint stimulation (TEAS ... This review introduces six major clinical applications of TEAS, named analgesia, regulation of gastrointestinal function, improvement of reproductive function, ...

8. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC8186381/

Transcutaneous Acupoint Electrical Stimulation on ... TAES was effective for alleviating constipation in NSCLC patients receiving chemotherapy and was a safe and practical nursing intervention.