TENS for Scleroderma

Overseen By Dinesh Khanna, MD, MSc

Age: 18+

Sex: Any

Trial Phase: Phase 1

Sponsor: University of Michigan

Must be taking: Prokinetics

Disqualifiers: Pregnancy, Major surgery, Diabetes, others

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

Approved in 3 Jurisdictions This treatment is already approved in other countries

Compensation: Varies

Number of Visits: Unknown

Duration: 14 months

16 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests a device called transcutaneous electrical acustimulation (TEA) to alleviate bloating and discomfort in individuals with scleroderma, a condition affecting the skin and connective tissues. The research aims to determine the device's acceptability and effectiveness in easing these symptoms. Participants will apply the device to their skin for 45 minutes, twice daily, after meals, and will track their symptoms. This trial may suit English-speaking individuals with scleroderma who experience ongoing bloating or distension despite stable treatment. As a Phase 1 trial, the research focuses on understanding how the treatment works in people, offering participants the opportunity to be among the first to receive this innovative treatment.

Will I have to stop taking my current medications?

The trial does not specify if you need to stop taking your current medications, but it requires that your gastrointestinal therapy, including prokinetics, has been stable for the last 4 weeks.

What prior data suggests that the TEA device is safe for treating Scleroderma-related gastroparesis?

Research shows that Transcutaneous Electrical Nerve Stimulation (TENS) is usually well-tolerated. Studies have found that TENS can be a safe and non-invasive method to reduce pain, even in conditions like systemic sclerosis, an autoimmune disease. A review of several studies provides moderate evidence supporting its safety for pain relief in adults.

Although this trial is in an early stage, with limited information on long-term safety for this specific condition, the use of TENS in other diseases offers some reassurance. Previous studies have not reported any major severe side effects linked to TENS, suggesting it could be a safe option for those considering joining the trial. ^{1 2 3 4 5}

Why do researchers think this study treatment might be promising?

Transcutaneous Electrical Nerve Stimulation (TENS) is unique because it uses electrical impulses to stimulate nerves, which can help manage pain and improve nerve function. Unlike the usual medications for scleroderma-related gastroparesis, which often focus on symptom relief through drugs like anti-nausea medications and prokinetics, TENS offers a non-invasive, drug-free alternative. Researchers are excited about TENS because it targets the nervous system directly, potentially offering relief without the side effects associated with pharmacological treatments. Additionally, TENS could provide a more immediate impact on symptoms, making it an appealing option for patients seeking quicker relief.

What evidence suggests that the TEA device is effective for Scleroderma-related gastroparesis?

Research has shown that transcutaneous electrical nerve stimulation (TENS) can improve stomach issues in people with scleroderma. Studies have found that TENS helps balance the body's stress and relaxation signals. This balance is linked to better control of symptoms like bloating and swelling, common in gastroparesis. Although the data is promising, this trial will explore TENS's effectiveness for scleroderma-related gastroparesis. Early results suggest it might provide relief, but further research is needed to confirm its effectiveness. ^{6 7 8 9 10}

Are You a Good Fit for This Trial?

This trial is for individuals with Scleroderma experiencing gastroparesis symptoms like bloating and distension. Participants will use a TEA device after meals and report their symptoms regularly.

Inclusion Criteria

English speaking

My stomach medication has been the same for the last month.

Classification of Systemic Sclerosis according to the 2013 American College of Rheumatology and European League against Rheumatism classification criteria

Exclusion Criteria

I have not had major abdominal surgery, except for gallbladder or appendix removal.

Pregnancy, or currently lactating

Known allergy to adhesive ECG electrodes

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants use the TEA device for 45 minutes twice daily after meals and complete daily diaries and biweekly questionnaires

14 months

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

What Are the Treatments Tested in This Trial?

Interventions

• Transcutaneous Electrical Nerve Stimulation

Trial Overview The study tests the acceptability of Transcutaneous Electrical Nerve Stimulation (TENS) to ease gastroparesis symptoms in Scleroderma patients, using devices applied to the skin for 45 minutes twice daily.

How Is the Trial Designed?

Group I: Scleroderma Patients with Gastroparesis Symptoms Experimental Treatment 1 Intervention

Transcutaneous Electrical Nerve Stimulation is already approved in United States, European Union, Canada for the following indications:

Approved in United States as TENS for:

• Pain management
• Musculoskeletal pain
• Neck pain
• Back pain
• Knee osteoarthritis pain
• Overactive bladder
• Urinary retention
• Temporomandibular joint dysfunction
• Essential tremor

Approved in European Union as TENS for:

• Pain management
• Musculoskeletal pain
• Neck pain
• Back pain
• Knee osteoarthritis pain
• Overactive bladder
• Urinary retention
• Temporomandibular joint dysfunction
• Essential tremor

Approved in Canada as TENS for:

• Pain management
• Musculoskeletal pain
• Neck pain
• Back pain
• Knee osteoarthritis pain
• Overactive bladder
• Urinary retention
• Temporomandibular joint dysfunction
• Essential tremor

Who Is Running the Clinical Trial?

University of Michigan

Lead Sponsor

Trials

1,891

Recruited

6,458,000+

Published Research Related to This Trial

Transcutaneous electrical nerve stimulation (TENS) is a noninvasive and easy-to-use therapy that may promote tissue repair, including wound healing and tendon repair, by increasing blood flow through the release of specific neuropeptides.

Despite the potential benefits suggested by 30 articles reviewed, the evidence remains inconclusive due to insufficient data from randomized controlled trials to definitively confirm the efficacy of TENS in tissue repair.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The effects of transcutaneous electrical nerve stimulation on tissue repair: A literature review. Machado, AF., Santana, EF., Tacani, PM., et al.[2022]

Lower skin impedance was found at optimal electrode sites for TENS treatment, suggesting that these sites may enhance the effectiveness of pain management techniques.

In a study with 24 healthy volunteers, both optimal and sham TENS treatments significantly increased pressure pain thresholds compared to a placebo, indicating that TENS is effective for pain relief, regardless of skin impedance at the electrode sites.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Skin impedance is not a factor in transcutaneous electrical nerve stimulation effectiveness. Vance, CG., Rakel, BA., Dailey, DL., et al.[2022]

In a study of 482 patients with chronic pain, effective patient evaluation and education were crucial for successful long-term outcomes with transcutaneous electrical nerve stimulation (TENS) therapy.

A prognostic score was developed to help select patients for TENS treatment based on various factors affecting outcomes, and this score was validated in a follow-up study with 99 patients.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Transcutaneous electrical nerve stimulation in the treatment of chronic pain: predictive factors and evaluation of the method. Lampl, C., Kreczi, T., Klingler, D.[2019]

A systematic review included 12 randomized controlled trials with 919 participants to evaluate the effectiveness of Transcutaneous Electrical Nerve Stimulation (TENS) for treating acute pain, but insufficient data prevented definitive conclusions.

The review highlighted that many studies were excluded because TENS was used alongside other treatments, indicating a need for more focused research on TENS as a standalone therapy for acute pain.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Transcutaneous electrical nerve stimulation for acute pain. Walsh, DM., Howe, TE., Johnson, MI., et al.[2022]

Transcutaneous nerve stimulation (TNS) has been effective in treating a patient with systemic sclerosis, alleviating symptoms such as Raynaud's phenomenon, ulcerations, foot pain, calcinosis, and dysphagia.

The report highlights TNS's potential mechanisms for improving microcirculation and promoting healing, which may be beneficial for patients with similar conditions.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Systemic sclerosis: successful treatment of ulcerations, pain, Raynaud's phenomenon, calcinosis, and dysphagia by transcutaneous nerve stimulation. A case report. Kaada, B.[2019]

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]

Citations

1. pubmed.ncbi.nlm.nih.gov pubmed.ncbi.nlm.nih.gov/17372833/

Transcutaneous electrical nerve stimulation (TENS ... - PubMed Transcutaneous electrical nerve stimulation (TENS) improves upper GI symptoms and balances the sympathovagal activity in scleroderma patients · Abstract.

2. centerwatch.com centerwatch.com/clinical-trials/listings/NCT06646913/tens-in-scleroderma

TENS in Scleroderma | Clinical Research Trial Listing Participants will be asked to fill out both daily diaries and biweekly questionnaires to assess for improvement in the gastroparesis symptoms.

3. researchgate.net researchgate.net/publication/6434208_Transcutaneous_Electrical_Nerve_Stimulation_TENS_Improves_Upper_GI_Symptoms_and_Balances_the_Sympathovagal_Activity_in_Scleroderma_Patients

(PDF) Transcutaneous Electrical Nerve Stimulation (TENS) ... Transcutaneous Electrical Nerve Stimulation (TENS) Improves Upper GI Symptoms and Balances the Sympathovagal Activity in Scleroderma Patients.

4. trial.medpath.com trial.medpath.com/clinical-trial/457eb4fcf998df7f/nct06646913-transcutaneous-electrical-nerve-stimulation-scleroderma

TENS in Scleroderma | MedPath Efficacy of TENS in treating Scleroderma-related Gastroparesis, 14 months. To assess the mean change in the GCSI Total score (0-4 where higher score reflects ...

5. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC9109510/

Management of scleroderma gastrointestinal disease: Lights ... Transcutaneous electrical nerve stimulation (TENS) improves upper GI symptoms and balances the sympathovagal activity in scleroderma patients. Dig Dis Sci ...

6. pubmed.ncbi.nlm.nih.gov pubmed.ncbi.nlm.nih.gov/37536947/

Transcutaneous auricular branch vagal nerve stimulation ... Conclusion: tVNS demonstrated to be a safe and non-invasive add-on tool to reduce pain in SSc. Keywords: autoimmune diseases; immune system diseases; systemic ...

7. trialfinder.panfoundation.org trialfinder.panfoundation.org/en-US/trial/listing/546575

TENS in Scleroderma The goal of this pilot study is to assess the acceptability of the transcutaneous electrical acustimulation (TEA) device in treating ...

8. sciencedirect.com sciencedirect.com/science/article/abs/pii/S2211034823000457

The effect of Transcutaneous Electrical Nerve Stimulation ... A meta-analysis examining the efficacy and safety of transcutaneous electrical nerve stimulation (TENS) for pain relief in adults provided moderate evidence ...

9. clinicaltrials.gov clinicaltrials.gov/study/NCT05500963

Reducing Fatigue in People With Multiple Sclerosis by ... Our central hypothesis is that treatment with TENS applied to selected leg muscles in people with MS will produce superior improvements in self-reported and ...

10. rarediseaseadvisor.com rarediseaseadvisor.com/news/transcutaneous-auricular-branch-vagal-nerve-stimulation/

tVNS Appears Safe and Effective in Systemic Sclerosis “In conclusion, our data support the use of tVNS as a non-invasive tool for the treatment of chronic pain in patients with SSc,” the authors ...