TENS for Peripheral Neuropathy

Overseen By Maria Noun, BS

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: Baylor College of Medicine

Disqualifiers: Pregnancy, Pacemakers, Diabetes, others

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

Compensation: Varies

Number of Visits: 2

Duration: 8 weeks

10 Participants Needed

Trial Summary

What is the purpose of this trial?

The purpose of this pilot study is to examine the acceptability and proof of concept effectiveness of a wireless Transcutaneous Electrical Nerve Stimulation (TENS) technology to address Chemotherapy Induced Peripheral Neuropathy (CIPN). Participants, who satisfy the inclusion and exclusion criteria and sign the informed consent form will be randomly assigned with ratio of 1:1 into two groups. The patients and clinicians will be blinded for group allocation. One group will utilize TENS high-dose devices (Intervention group, IG); the other group will utilize low-dose TENS devices (Placebo group, PG). The baseline measurements will be performed, and the patients will take the programmed device home for a duration of 8 weeks. Then, the patients will come back after four weeks (4W) and after 8 weeks (8W) for outcome assessment. The primary outcome will be pain. Secondary outcomes include: nerve conduction and velocity, vibration perception threshold, quality of life. Exploratory outcomes include gait assessment (gait speed, stride length, double stance, and gait steadiness), and balance.

Do I need to stop my current medications to join the trial?

The trial protocol does not specify if you need to stop taking your current medications. However, it does exclude certain conditions and treatments, like nerve blocks a week prior to enrollment and the use of electrical implanted devices.

What data supports the idea that TENS for Peripheral Neuropathy is an effective treatment?

The available research shows that TENS is a widely used treatment for managing pain, including diabetic peripheral neuropathy. A meta-analysis of randomized controlled trials specifically evaluated TENS for diabetic peripheral neuropathy, suggesting its effectiveness. Additionally, TENS is described as a non-drug, non-invasive, and easy-to-use method for pain relief, which makes it a popular choice in clinical practice. While the research does not provide specific data points, it indicates that TENS is a common and potentially effective option for treating neuropathic pain. ^{1 2 3 4 5}

What safety data is available for TENS in treating peripheral neuropathy?

The provided research does not contain specific safety data for TENS (Transcutaneous Electrical Nerve Stimulation) in treating peripheral neuropathy. The studies focus on transdermal nicotine systems (TNS) for smoking cessation, discussing side effects like erythema and systemic reactions, but do not address TENS or its safety profile. ^{6 7 8 9 10}

Is TENS a promising treatment for peripheral neuropathy?

Yes, TENS is a promising treatment for peripheral neuropathy because it is non-invasive, easy to use, and effective in reducing pain. It is popular among patients and health professionals for managing different types of pain, including those related to diabetic peripheral neuropathy. ^{2 3 4 5 11}

Eligibility Criteria

This trial is for individuals experiencing nerve pain due to chemotherapy (CIPN). Participants must meet certain criteria and agree to the study's terms. Specific inclusion and exclusion details are not provided, but typically involve health status and treatment history.

Inclusion Criteria

I am 18 or older and agree to participate in the study.

I have had chemotherapy with a drug that can affect the nerves.

I finished chemotherapy over a month ago and still have nerve pain.

Exclusion Criteria

I use ointments on my legs.

I plan to start chemotherapy within the next 3 months.

I have nerve damage due to uncontrolled diabetes.

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive daily TENS therapy with either high-dose or low-dose devices for 8 weeks

8 weeks

2 visits (in-person) at 4 weeks and 8 weeks

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

Treatment Details

Interventions

• Transcutaneous Electrical Nerve Stimulation (TENS)

Trial Overview The study tests wireless TENS devices at two different doses: high-dose (Intervention group) versus low-dose (Placebo group). Patients will use these devices over an 8-week period with follow-up assessments focused on pain relief, nerve function, quality of life, gait, and balance.

Participant Groups

Group I: Intervention Group Active Control 1 Intervention

The intervention group will be undergoing Transcutaneous Electrical Nerve Stimulation (TENS) therapy on a daily basis with a high-dose TENS device for 8 weeks. The high-dose TENS device elicits 1 hour of TENS per session. Subjects are instructed to complete at least 3 sessions per day. To deliver TENS, a band strap with hydrogel pads will be placed around the calf muscle of one lower-extremity alternating to the other side on a weekly basis.

Group II: Placebo Group Placebo Group 1 Intervention

The placebo group will be undergoing Transcutaneous Electrical Nerve Stimulation (TENS) therapy on a daily basis with a low-dose TENS device for 8 weeks. The low-dose TENS device is identical to the high-dose TENS device in all respects except that it delivers 6 minutes of TENS therapy per session (10% out of 60 minutes). Subjects are instructed to complete at least 3 sessions per day. To deliver TENS, a band strap with hydrogel pads will be placed around the calf muscle of one lower-extremity alternating to the other side on a weekly basis.

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

Approved in United States as TENS for:

• Chronic pain
• Acute pain
• Postoperative pain
• Low back pain
• Osteoarthritis pain
• Diabetic peripheral neuropathy
• Fibromyalgia
• Neuropathic pain

Approved in European Union as TENS for:

• Chronic pain
• Acute pain
• Postoperative pain
• Low back pain
• Osteoarthritis pain
• Diabetic peripheral neuropathy
• Fibromyalgia
• Neuropathic pain

Approved in Canada as TENS for:

• Chronic pain
• Acute pain
• Postoperative pain
• Low back pain
• Osteoarthritis pain
• Diabetic peripheral neuropathy
• Fibromyalgia
• Neuropathic pain

Who Is Running the Clinical Trial?

Baylor College of Medicine

Lead Sponsor

Trials

1,044

Recruited

6,031,000+

NeuroMetrix, Inc.

Industry Sponsor

Trials

7

Recruited

370+

Findings from Research

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]

In a study of 75 diabetic patients with neuropathic pain, high-frequency TENS (HF TENS) was found to be significantly more effective than low-frequency TENS (LF TENS) in reducing pain intensity and improving sensory aspects of pain, with a 34.7% greater analgesic effect based on visual analogue scale (VAS) assessments.

TENS therapy, when combined with standard drug treatments, enhanced pain relief by 65.9% and maintained its effectiveness for up to 6 months, indicating that TENS can be a valuable addition to conventional treatments for neuropathic pain.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Clinical Experience of High Frequency and Low Frequency TENS in Treatment of Diabetic Neuropathic Pain in Russia. Al-Zamil, M., Minenko, IA., Kulikova, NG., et al.[2022]

Transcutaneous electrical nerve stimulation (TENS) significantly reduced pain scores in patients with diabetic peripheral neuropathy (DPN) compared to placebo at 4 and 6 weeks, indicating its effectiveness as a treatment option.

TENS therapy was found to be safe, with no reported adverse events, and it also improved overall neuropathic symptoms after 12 weeks, although further research with larger sample sizes is needed to confirm long-term benefits.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Effect of transcutaneous electrical nerve stimulation on symptomatic diabetic peripheral neuropathy: a meta-analysis of randomized controlled trials. Jin, DM., Xu, Y., Geng, DF., et al.[2022]

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]

Transdermal therapeutic systems (TTSs) are effective for delivering various medications, offering advantages like ease of use and consistent drug levels in the body.

However, adverse skin reactions are a common issue with TTSs, highlighting the need for awareness and management of these side effects when using new TTS medications such as buprenorphine and diclofenac.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Cutaneous reactions to transdermal therapeutic systems. Bershow, A., Warshaw, E.[2017]

Transdermal drug delivery systems (TDS) offer a unique method for administering medications through the skin, but they can lead to dermatological issues like irritation and sensitization.

Understanding the pharmacokinetics of TDS is crucial, as factors such as skin occlusion and epidermal metabolism can significantly affect drug absorption and efficacy.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

[Transdermal therapeutic systems (TTS)]. Niedner, R.[2006]

In a study of 112 young, nicotine-dependent smokers, those using a transdermal nicotine system (TNS) had a significantly higher abstinence rate of 39.3% compared to 19.6% in the placebo group after nine weeks, indicating the efficacy of TNS in aiding tobacco withdrawal.

While TNS users experienced some reduction in withdrawal symptoms like tension and difficulty concentrating, the treatment was associated with mild skin reactions at the application site in 20% of users, suggesting that while TNS is effective, it may cause some localized side effects.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

[Weaning of young smokers using a transdermal nicotine patch]. Ehrsam, RE., Bühler, A., Müller, P., et al.[2022]

The transdermal nicotine system (TNS) effectively doubles smoking cessation rates compared to placebo, with abstinence rates of 36% and 39% in TNS groups versus 23% and 20% in placebo groups over 3 months and 9 weeks, respectively.

The TNS maintains plasma nicotine levels similar to those in smokers, suggesting it can be a practical option for smoking cessation even with minimal support, making it accessible for general medical advice settings.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The use of transdermal nicotine in smoking cessation. Müller, P., Abelin, T., Ehrsam, R., et al.[2019]

In a study of 584 patients with cardiovascular disease, transdermal nicotine therapy did not significantly increase the risk of serious cardiovascular events compared to a placebo, suggesting it is safe for use in this population.

While transdermal nicotine was effective in achieving higher smoking cessation rates (21% vs. 9% for placebo) after 14 weeks, this effect was not maintained at 24 weeks, indicating that its long-term efficacy may be limited.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The safety of transdermal nicotine as an aid to smoking cessation in patients with cardiac disease. Joseph, AM., Norman, SM., Ferry, LH., et al.[2015]

A systematic review of 19 randomized controlled trials (RCTs) on transcutaneous electrical nerve stimulation (TENS) for chronic pain found that while active TENS showed positive analgesic outcomes in 10 out of 15 studies compared to inactive controls, the overall evidence is inconclusive due to poor methodological quality and variability in study designs.

The review highlighted a lack of clarity on the optimal stimulation parameters for TENS and emphasized the need for larger, well-designed multi-centre trials to better assess the long-term effectiveness of TENS in managing chronic pain.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Transcutaneous electrical nerve stimulation (TENS) for chronic pain. Carroll, D., Moore, RA., McQuay, HJ., et al.[2018]

References

1. 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]

2. England pubmed.ncbi.nlm.nih.gov

Transcutaneous electrical nerve stimulation for acute pain. [2022]

3. Switzerland pubmed.ncbi.nlm.nih.gov

Clinical Experience of High Frequency and Low Frequency TENS in Treatment of Diabetic Neuropathic Pain in Russia. [2022]

4. Ireland pubmed.ncbi.nlm.nih.gov

Effect of transcutaneous electrical nerve stimulation on symptomatic diabetic peripheral neuropathy: a meta-analysis of randomized controlled trials. [2022]

5. Canada pubmed.ncbi.nlm.nih.gov

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

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

Cutaneous reactions to transdermal therapeutic systems. [2017]

7. Germany pubmed.ncbi.nlm.nih.gov

[Transdermal therapeutic systems (TTS)]. [2006]

8. Switzerland pubmed.ncbi.nlm.nih.gov

[Weaning of young smokers using a transdermal nicotine patch]. [2022]

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

The use of transdermal nicotine in smoking cessation. [2019]

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

The safety of transdermal nicotine as an aid to smoking cessation in patients with cardiac disease. [2015]

11. England pubmed.ncbi.nlm.nih.gov

Transcutaneous electrical nerve stimulation (TENS) for chronic pain. [2018]