TEA for Constipation in Systemic Sclerosis

(TEA in SSc Trial)

Overseen By Sharvari R Kamat

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: The University of Texas Health Science Center, Houston

Disqualifiers: Diarrhea, others

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

Compensation: Varies

Number of Visits: 2

Duration: 4 weeks

60 Participants Needed

Trial Summary

What is the purpose of this trial?

The purpose of this study is to determine whether transcutaneous electrical acustimulation (TEA) alters systemic sclerosis (SSc)-related colonic and anorectal physiology by enhancing autonomic nervous system (ANS) function. The study will examine the effects of TEA on slow colonic transit (SCT) and rectal hyposensitivity (RH), to examine whether TEA improves autonomic dysfunction and modulates inflammatory pathways.

Will I have to stop taking my current medications?

The trial does not specify if you need to stop your current medications. However, you can participate if you are not on therapy for constipation or if you have been on stable therapy for constipation for at least one month before starting the trial.

What data supports the effectiveness of the treatment TEA for Constipation in Systemic Sclerosis?

Research shows that transcutaneous electrical nerve stimulation (TENS), a component of TEA, can improve gastrointestinal symptoms and quality of life in scleroderma patients by balancing nerve activity and reducing symptom scores. ^{1 2 3 4 5}

Is transcutaneous electrical acustimulation (TEA) safe for humans?

Research indicates that transcutaneous electrical acustimulation (TEA) and similar treatments like transcutaneous electrical stimulation (TES) are generally safe for humans, as they have been used in studies for conditions like chronic constipation and motion sickness without significant safety concerns. ^{6 7 8 9 10}

How is the Sham-TEA treatment for constipation in systemic sclerosis different from other treatments?

Sham-TEA, or Transcutaneous Electrical Acustimulation, is unique because it uses electrical stimulation on the skin to target specific points, potentially improving constipation by influencing nerve activity, unlike traditional treatments that often involve medications or dietary changes. ^{6 7 9 11 12}

Research Team

Zsuzsanna H McMahan, MD, MHS (M-PI)

Principal Investigator

The University of Texas Health Science Center, Houston

Eligibility Criteria

This trial is for patients with systemic sclerosis (SSc) who are experiencing constipation. It's open to those not yet treated for constipation or those still having issues despite stable therapy for a month. Participants should have slow colonic transit or rectal hyposensitivity as defined in the study, but can't join if they have both diarrhea and constipation symptoms.

Inclusion Criteria

I have constipation and haven't started treatment or it hasn't improved with current treatment.

Patients with constipation related to systemic sclerosis from the first part of the study.

You still have a lot of the markers left in your colon 5 days after swallowing the capsule, or you have a condition called RH.

Exclusion Criteria

I experience both diarrhea and constipation, but mainly have diarrhea.

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive transcutaneous electrical acustimulation (TEA) to assess its effects on colonic and anorectal physiology

4 weeks

2 visits (in-person)

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

Treatment Details

Interventions

• Sham-TEA
• Transcutaneous Electrical Acustimulation (TEA)

Trial Overview The study tests whether transcutaneous electrical acustimulation (TEA), which involves using electrical currents on the skin, can improve bowel function and sensitivity by enhancing autonomic nervous system activity in SSc patients. The effects of TEA versus Sham-TEA (a pretend treatment) are compared.

Participant Groups

Group I: Transcutaneous Electrical Acustimulation (TEA) Experimental Treatment 1 Intervention

Group II: Sham-TEA Placebo Group 1 Intervention

Who Is Running the Clinical Trial?

The University of Texas Health Science Center, Houston

Lead Sponsor

Trials

974

Recruited

361,000+

National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS)

Collaborator

Trials

508

Recruited

1,090,000+

Findings from Research

In a study involving 17 scleroderma patients, transcutaneous electrical nerve stimulation (TENS) applied at gastrointestinal acupoints significantly improved GI symptoms and quality of life after 14 days of treatment.

TENS not only increased sympathetic and vagal activities acutely but also normalized the sympathovagal balance over time, leading to decreased GI symptom scores and improved physical functioning, indicating its potential as a treatment option for upper GI symptoms.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Transcutaneous electrical nerve stimulation (TENS) improves upper GI symptoms and balances the sympathovagal activity in scleroderma patients. Sallam, H., McNearney, TA., Doshi, D., et al.[2022]

In a study involving 17 scleroderma patients, two weeks of daily transcutaneous electrical nerve stimulation (TENS) significantly improved gastric myoelectrical activity, indicating enhanced neurogastric functioning.

Prolonged TENS treatment also led to decreased levels of plasma VIP, motilin, and IL-6, which are associated with gastrointestinal function, and reduced symptoms like abdominal pain and bloating.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Prolonged treatment with transcutaneous electrical nerve stimulation (TENS) modulates neuro-gastric motility and plasma levels of vasoactive intestinal peptide (VIP), motilin and interleukin-6 (IL-6) in systemic sclerosis. McNearney, TA., Sallam, HS., Hunnicutt, SE., et al.[2022]

In a study involving 11 patients with progressive systemic sclerosis (PSS), electrical acupuncture significantly reduced plasma endothelin-1 (ET-1) levels, suggesting a potential mechanism for improved blood flow and temperature in affected areas.

While electrical acupuncture decreased ET-1 levels in PSS patients, it had varying effects on patients with scleroderma spectrum disorders (SSD), indicating that the treatment's efficacy may differ based on the specific condition.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The effect of electrical acupuncture-stimulation therapy using thermography and plasma endothelin (ET-1) levels in patients with progressive systemic sclerosis (PSS). Maeda, M., Kachi, H., Ichihashi, N., et al.[2019]

A self-administered finger stretching program significantly improved passive range of motion (ROM) in patients with systemic sclerosis (SSc) after just one month, with continued improvements or maintenance of ROM observed over a year.

The program also led to better hand function, as indicated by a significant decrease in the Health Assessment Questionnaire (HAQ) score, suggesting that stretching can enhance daily activities like eating and gripping for SSc patients.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The efficacy of self-administered stretching for finger joint motion in Japanese patients with systemic sclerosis. Mugii, N., Hasegawa, M., Matsushita, T., et al.[2015]

In a study involving 32 patients with systemic sclerosis (SSc), transcutaneous auricular vagal nerve stimulation (tVNS) significantly reduced pain levels by an average of 27.7%, while the active control only showed a 7.7% reduction, indicating tVNS's efficacy in pain management.

tVNS also led to a significant decrease in the inflammatory marker interleukin-6 compared to the active control, suggesting a potential mechanism for its pain-relieving effects, although it did not show significant improvements in overall quality of life or heart rate variability.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Transcutaneous auricular branch vagal nerve stimulation as a non-invasive add-on therapeutic approach for pain in systemic sclerosis. Bellocchi, C., Carandina, A., Della Torre, A., et al.[2023]

Transcutaneous electrical stimulation (TES) significantly improved symptoms of slow-transit constipation in a study of 28 women, with notable decreases in constipation severity and abdominal pain, as well as an increase in the frequency of bowel movements.

The treatment was applied for 20 minutes, three times a week over 4 weeks, and while both the treatment and control groups reported reduced abdominal pain, only the TES group showed a significant increase in evacuation frequency, highlighting its potential efficacy.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Improving slow-transit constipation with transcutaneous electrical stimulation in women: A randomized, comparative study. Yang, Y., Yim, J., Choi, W., 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]

Transcutaneous electrical acustimulation (TEA) significantly improved postoperative recovery in women after cesarean section, leading to faster gastrointestinal recovery, including reduced time to first flatus and defecation, and improved stool quality.

TEA enhanced vagal activity and reduced sympathetic activity, which are associated with better gastrointestinal function and lower pain levels, indicating its potential as an effective non-invasive treatment for postoperative care.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Effects and Mechanisms of Transcutaneous Electrical Acustimulation on Postoperative Recovery After Elective Cesarean Section. Li, M., Xu, F., Liu, M., et al.[2022]

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) significantly improved tolerance to motion sickness (MS) in healthy participants, with 22 out of 50 completing all five rotations compared to only 11 in the sham group, and it also prolonged the total tolerable rotation time (220.4 seconds vs 173.6 seconds).

TEA reduced MS symptoms and improved gastric function by enhancing vagal activity and suppressing the increase of stress-related hormones like arginine vasopressin and norepinephrine during motion stimulation, indicating its potential as an effective treatment for severe motion sickness.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Transcutaneous Electrical Acustimulation Ameliorates Motion Sickness Induced by Rotary Chair in Healthy Subjects: A Prospective Randomized Crossover Study. Zhao, Q., Ning, BF., Zhou, JY., et al.[2022]

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]

Home transcutaneous electrical stimulation (TES) significantly improved bowel function in children with slow-transit constipation (STC), with 69% of patients experiencing increased defecation frequency and 50% showing reduced soiling after 3 to 6 months of self-administration.

The study involved 32 children, and results indicated that TES not only enhanced bowel movements but also improved stool consistency and reduced abdominal pain, highlighting its potential as an effective treatment option for STC when administered under clinician guidance.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Home transcutaneous electrical stimulation to treat children with slow-transit constipation. Yik, YI., Ismail, KA., Hutson, JM., et al.[2015]

References

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

Transcutaneous electrical nerve stimulation (TENS) improves upper GI symptoms and balances the sympathovagal activity in scleroderma patients. [2022]

2. Italy pubmed.ncbi.nlm.nih.gov

Prolonged treatment with transcutaneous electrical nerve stimulation (TENS) modulates neuro-gastric motility and plasma levels of vasoactive intestinal peptide (VIP), motilin and interleukin-6 (IL-6) in systemic sclerosis. [2022]

3. Netherlands pubmed.ncbi.nlm.nih.gov

The effect of electrical acupuncture-stimulation therapy using thermography and plasma endothelin (ET-1) levels in patients with progressive systemic sclerosis (PSS). [2019]

4. Canada pubmed.ncbi.nlm.nih.gov

The efficacy of self-administered stretching for finger joint motion in Japanese patients with systemic sclerosis. [2015]

5. England pubmed.ncbi.nlm.nih.gov

Transcutaneous auricular branch vagal nerve stimulation as a non-invasive add-on therapeutic approach for pain in systemic sclerosis. [2023]

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

Improving slow-transit constipation with transcutaneous electrical stimulation in women: A randomized, comparative study. [2018]

7. Switzerland pubmed.ncbi.nlm.nih.gov

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

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

Effects and Mechanisms of Transcutaneous Electrical Acustimulation on Postoperative Recovery After Elective Cesarean Section. [2022]

9. 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]

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

Transcutaneous Electrical Acustimulation Ameliorates Motion Sickness Induced by Rotary Chair in Healthy Subjects: A Prospective Randomized Crossover Study. [2022]

11. China pubmed.ncbi.nlm.nih.gov

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

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

Home transcutaneous electrical stimulation to treat children with slow-transit constipation. [2015]