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

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial aims to assess the effectiveness and acceptability of a new wireless TENS (Transcutaneous Electrical Nerve Stimulation) device for managing pain from Chemotherapy Induced Peripheral Neuropathy (CIPN). Participants will be divided into two groups: one using a high-dose TENS device and the other a low-dose version. The researchers will determine if the higher dose provides better pain relief and improves quality of life. Ideal candidates have completed chemotherapy at least a month ago, experience moderate CIPN, and can use a smartphone app. As an unphased trial, this study offers patients the chance to contribute to innovative pain management solutions and potentially enhance their quality of life.

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 prior data suggests that this TENS technology is safe for addressing Chemotherapy Induced Peripheral Neuropathy?

Research has shown that Transcutaneous Electrical Nerve Stimulation (TENS) is generally safe for most people. Studies have found that TENS can reduce pain without causing serious side effects. Most individuals do not experience major health issues when using TENS. However, consulting a doctor before trying it is important, especially for those with certain health conditions, such as a pacemaker. Overall, TENS is well-tolerated, but consulting a healthcare provider ensures its suitability. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about Transcutaneous Electrical Nerve Stimulation (TENS) for peripheral neuropathy because it offers a non-invasive and drug-free alternative to traditional treatments like pain medications, which often come with side effects. TENS delivers electrical impulses through the skin to stimulate nerves and help manage pain, potentially providing relief without the need for pharmaceuticals. This method is particularly promising because it allows patients to control their own treatment through a portable device, making it a convenient option for managing symptoms on a daily basis.

What evidence suggests that this TENS device is effective for Chemotherapy Induced Peripheral Neuropathy?

This trial will compare the effects of high-dose TENS therapy with a placebo group using low-dose TENS therapy. Studies have shown that TENS, or Transcutaneous Electrical Nerve Stimulation, can alleviate nerve pain. Some research suggests that TENS therapy led to noticeable symptom improvements over 12 weeks. Another study found that TENS might reduce the impact of pain on daily life. However, not all studies agree on its effectiveness compared to placebo treatments. Overall, evidence indicates that TENS can be helpful, but results may vary. ^{1 6 7 8 9}

Are You a Good Fit for This Trial?

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 for a Trial Participant

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

What Are the Treatments Tested in This Trial?

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.

How Is the Trial Designed?

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+

Published Research Related to This Trial

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]

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]

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]

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]

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]

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]

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]

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]

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]

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]

Citations

1. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC6426434/

Transcutaneous electrical nerve stimulation (TENS) for ... For adults with neuropathic pain, it is impossible to confidently state whether TENS is effective in relieving pain when compared to sham TENS.

2. pubmed.ncbi.nlm.nih.gov pubmed.ncbi.nlm.nih.gov/20510476/

Effect of transcutaneous electrical nerve stimulation on ... TENS therapy was associated with significantly subjective improvement in overall neuropathic symptoms in 12 weeks follow-up [WMD-0.18, 95% CI (-0.32, -0.051)].

3. clinicaltrials.gov clinicaltrials.gov/study/NCT04367480

Effects of Transcutaneous Electrical Nerve Stimulation on ... This phase II trial studies the effects of transcutaneous electrical nerve stimulation (TENS) for the treatment of peripheral neuropathy caused by ...

4. sciencedirect.com sciencedirect.com/science/article/pii/S1524904224003084

Peripheral Percutaneous Electrical Nerve Stimulation for ... The results obtained show that PENS statistically significantly reduces pain intensity (−3.57 [−4.01, −3.13]; p < .05). There is no heterogeneity between ...

5. mdpi.com mdpi.com/1648-9144/58/2/284

Effects of Transcutaneous Electrical Nerve Stimulation on ... The authors reported that TENS ensured lower maximum pain interference scores (Wilcoxon p = 0.04, which was considered significant), although there were no ...

6. ncbi.nlm.nih.gov ncbi.nlm.nih.gov/books/NBK537188/

Transcutaneous Electrical Nerve Stimulation - StatPearls - NCBI Despite its safety profile, there are cautions associated with TENS use.[16] Due to potential complications, individuals with pacemakers, ...

7. my.clevelandclinic.org my.clevelandclinic.org/health/treatments/15840-transcutaneous-electrical-nerve-stimulation-tens

Transcutaneous Electrical Nerve Stimulation (TENS) In most cases, using a TENS unit shouldn't cause any serious health issues. But it's important to check with your healthcare provider before you try it.

8. bmjopen.bmj.com bmjopen.bmj.com/content/12/2/e051073

Efficacy and safety of transcutaneous electrical nerve ... There was moderate-certainty evidence that pain intensity is lower during or immediately after TENS compared with placebo and without serious adverse events.

9. sciencedirect.com sciencedirect.com/science/article/pii/S152659002300617X

A Proof-of-Concept Randomized Clinical Trial Daily, home-based TENS therapy demonstrates promising efficacy for painful CIPN symptoms in this proof-of-concept randomized clinical trial.