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

Trial Summary

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 data supports the effectiveness of the treatment TENS for Scleroderma?

Research shows that TENS can improve blood flow and help heal chronic skin wounds, which may be beneficial for scleroderma patients who often experience skin issues. Additionally, TENS has been effective in reducing pain and improving symptoms in conditions like Raynaud's phenomenon, which is common in scleroderma. ^{1 2 3 4 5}

How is the TENS treatment different from other treatments for scleroderma?

TENS is unique because it is a non-drug treatment that uses low voltage electrical currents applied to the skin to help manage pain and improve circulation, which can aid in healing skin ulcers and alleviate symptoms like Raynaud's phenomenon in scleroderma patients. ^{1 2 4 5 6}

What is the purpose of this trial?

The goal of this pilot study is to assess the acceptability of the transcutaneous electrical acustimulation (TEA) device in treating Scleroderma-related gastroparesis. The main objective is: To evaluate the acceptability of TEA as an intervention for alleviating symptoms of distension and bloating in individuals diagnosed with Scleroderma. Participants will be provided with the TEA devices that will be applied to the skin for a total of 45 minutes twice daily after meals. Participants will be asked to fill out both daily diaries and biweekly questionnaires to assess for improvement in the gastroparesis symptoms.

Eligibility Criteria

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

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

English speaking

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

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

Treatment Details

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.

Participant Groups

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+

Findings from Research

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]

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 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]

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 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]

References

1. Canada pubmed.ncbi.nlm.nih.gov

The effects of transcutaneous electrical nerve stimulation on tissue repair: A literature review. [2022]

2. United States 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. [2019]

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

Transcutaneous electrical nerve stimulation in the treatment of chronic pain: predictive factors and evaluation of the method. [2019]

4. England pubmed.ncbi.nlm.nih.gov

Transcutaneous electrical nerve stimulation for acute pain. [2022]

5. New Zealand pubmed.ncbi.nlm.nih.gov

Skin impedance is not a factor in transcutaneous electrical nerve stimulation effectiveness. [2022]

6. 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]