Wearable Focal Vibration for Peripheral Neuropathy

Not currently recruiting at 1 trial location

Overseen By Abby Cha, BS

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: University of Oklahoma

Disqualifiers: Non-chemotherapy neuropathy, Musculoskeletal injury, Pregnancy, others

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

Approved in 2 Jurisdictions This treatment is already approved in other countries

Compensation: Varies

Number of Visits: 2

Duration: 6 weeks

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial explores whether a wearable device that delivers gentle vibrations can ease the symptoms of chemotherapy-induced peripheral neuropathy (CIPN), a nerve condition causing pain and discomfort in the feet. The researchers aim to determine if this vibration therapy, known as Focal Vibration Therapy, can improve the daily lives of those experiencing persistent pain or interference in activities due to CIPN. Individuals with stable yet ongoing painful nerve symptoms in their feet for at least three months after chemotherapy might be suitable for this trial. Participants should also be able to stand and walk short distances without assistance. As an unphased trial, this study offers a unique opportunity to contribute to innovative research that could enhance the quality of life for those with CIPN.

Will I have to stop taking my current medications?

You don't have to stop taking your current medications, but your pain medication must be stable for two weeks before joining the study, and you should avoid making big changes to it during the study.

What prior data suggests that this focal vibration therapy is safe for peripheral neuropathy?

Research has shown that focal vibration therapy is generally safe. Studies have found that this therapy can significantly improve pain, balance, and movement in individuals with diabetic peripheral neuropathy. For instance, one study reported that after four weeks of using wearable vibration devices on muscles, participants experienced improved movement and reduced pain. These studies reported no major side effects, indicating that the treatment is well-tolerated. The therapy involves placing a vibrating device on the skin, which participants found comfortable and adjustable to a strong but pleasant level. Overall, based on these early findings, the treatment appears safe. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about focal vibration therapy for peripheral neuropathy because it offers a non-invasive way to manage symptoms using a unique delivery method. Unlike typical treatments that may involve medications like pain relievers or topical creams, this therapy uses wearable devices to deliver vibrations directly to affected areas. The vibrations are set to a frequency between 50-80 Hz, allowing users to adjust the intensity to a level that feels strong yet comfortable. This personalized and drug-free approach has the potential to provide relief without the side effects commonly associated with traditional medications.

What evidence suggests that focal vibration therapy is effective for peripheral neuropathy?

Research has shown that focal vibration therapy, which participants in this trial will receive, can relieve pain and improve movement in nerve-related conditions. Studies have found that people with diabetic peripheral neuropathy who used this therapy experienced better balance and reduced pain after just four weeks. Another study demonstrated that some individuals experienced quick pain relief, even after their first session. This therapy sends gentle vibrations to muscles, potentially easing nerve pain and enhancing movement. While more research is needed, early results are promising for those with peripheral neuropathy. ^{1 3 6 7 8}

Who Is on the Research Team?

Elizabeth Hile, PhD

Principal Investigator

University of Oklahoma

Are You a Good Fit for This Trial?

This trial is for adults over 18 with painful or function-affecting nerve damage in the feet due to chemotherapy, stable for at least 3 months. Participants must have a consistent pain medication regimen and be able to stand and walk short distances unaided. They should not have neuropathy from other causes, lower limb loss, recent injuries affecting movement, or be pregnant.

Inclusion Criteria

I understand and remember the key points of the study.

My pain medication has been the same for the last two weeks and I agree not to change it during the study.

I have had painful or severe nerve pain in my feet from chemotherapy for over 3 months.

Exclusion Criteria

I have a recent injury affecting my physical ability.

I have neuropathy not caused by chemotherapy or diabetes.

I am not pregnant nor planning to be in the next 6 months, but will inform the study team if I become pregnant.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Baseline Assessment

Participants undergo baseline assessments of questionnaires and performance tests, and may repeat these tests within a few days as a double-baseline

1 week

1-2 visits (in-person)

Treatment

Participants complete 6 weeks of daily at-home therapy with a Myovolt wearable FV device, with weekly remote check-ins

6 weeks

Weekly remote check-ins

Follow-up

Participants are monitored for safety and effectiveness after treatment, with at least one remote check-in

6 weeks

At least 1 remote check-in

What Are the Treatments Tested in This Trial?

Interventions

• Focal Vibration Therapy

Trial Overview The study is testing focal vibration therapy as a treatment for persistent symptoms of chemotherapy-induced peripheral neuropathy (CIPN). It's an early Phase I trial with a single group of participants who will receive the therapy to see if it helps improve their CIPN symptoms.

How Is the Trial Designed?

Group I: Focal vibration therapy Experimental Treatment 1 Intervention

Myovolt delivers vibration with a frequency between 50-80 Hz. Myovolt intensity will be set to \~up to 2X the participant's initial Myovolt perception threshold. If the stimulation does not feel strong, the participant will be asked to manually increase the intensity until it feels strong but comfortable.

Focal Vibration Therapy is already approved in European Union, United States for the following indications:

Approved in European Union as Focal Vibration Therapy for:

• Musculoskeletal conditions
• Neurological rehabilitation
• Spasticity management

Approved in United States as Focal Vibration Therapy for:

• Chronic pain management
• Rehabilitation after stroke
• Peripheral neuropathy

Who Is Running the Clinical Trial?

University of Oklahoma

Lead Sponsor

Trials

484

Recruited

95,900+

Published Research Related to This Trial

Focal muscle vibration at 80 Hz and amplitudes of 0.3 mm and 0.5 mm effectively inhibits the H-reflex in healthy subjects, suggesting potential benefits for reducing spasticity in patients with lower limb issues.

The study indicates that using focal vibration as an adjuvant therapy during gait rehabilitation could be beneficial for patients with calf muscle spasticity, warranting further clinical trials to explore its efficacy.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Effect of Focal Muscle Vibration on Calf Muscle Spasticity: A Proof-of-Concept Study. Seo, HG., Oh, BM., Leigh, JH., et al.[2022]

Whole body vibration (WBV) therapy significantly improves pain, neuropathy disability, balance, and quality of life in patients with painful diabetic peripheral neuropathy (PDPN) after six weeks of treatment, as shown in a study of 26 participants.

The study found that WBV therapy led to notable improvements in various measures, including pain ratings and vibration perception, compared to a control group receiving standard care, highlighting its potential as an effective adjunct therapy for PDPN.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Whole body vibration showed beneficial effect on pain, balance measures and quality of life in painful diabetic peripheral neuropathy: a randomized controlled trial. Jamal, A., Ahmad, I., Ahamed, N., et al.[2022]

In a study involving 32 participants (17 with diabetic neuropathy and 15 nondisabled), vibrating insoles improved standing balance in individuals with neuropathy, but only when they were distracted by an attention-demanding task.

No balance improvement was observed in nondisabled subjects, suggesting that the vibrating insoles may specifically benefit those with balance issues related to neuropathy, highlighting the need for further development to enhance their effectiveness in daily use.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Effects of vibrating insoles on standing balance in diabetic neuropathy. Hijmans, JM., Geertzen, JH., Zijlstra, W., et al.[2022]

An 8-week program of low-frequency plantar vibration training significantly improved nerve conduction velocity in the feet of 12 patients with diabetic peripheral neuropathy (DPN).

Participants also experienced enhanced postural stability and a reduction in pain and tingling sensations, indicating the training's potential benefits for managing DPN symptoms.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Positive effects of plantar vibration training for the treatment of diabetic peripheral neuropathy: A pilot study. Stambolieva, K., Petrova, D., Irikeva, M.[2018]

Local calf vibration therapy significantly improved balance in patients with diabetic peripheral neuropathy (DPN), as indicated by an increase in the Brief BESTest scores from 14.06 to 17.35 after treatment.

The therapy also led to a notable increase in common peroneal nerve conduction velocity in the treated leg compared to the control leg, suggesting potential benefits for nerve function in DPN patients.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The effects of local calf vibration on balance, blood flow, and nerve conductivity in patients with diabetic peripheral neuropathy: a pilot study. Fateh, HR., Nakhostin Ansari, N., Nakhostin-Ansari, A., et al.[2023]

A 4-week study involving 23 participants with diabetic peripheral neuropathy showed that wearable focal muscle vibration (FMV) therapy significantly reduced pain levels and improved mobility, with participants reporting high satisfaction and compliance.

While balance and sensation improvements were noted, they were not statistically significant; however, there was a trend suggesting that better balance may correlate with reduced pain levels.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Wearable Focal Muscle Vibration on Pain, Balance, Mobility, and Sensation in Individuals with Diabetic Peripheral Neuropathy: A Pilot Study. Chandrashekhar, R., Wang, H., Dionne, C., et al.[2021]

Focal vibratory treatment (FVT) applied to muscles can lead to significant improvements in muscle force and power in healthy adults, with effects lasting for several months after treatment.

The most effective FVT involves applying vibrations at a frequency of approximately 100 Hz to voluntarily contracted muscles, repeated multiple times over three to five days, showing comparable benefits to traditional training methods.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Is the Focal Muscle Vibration an Effective Motor Conditioning Intervention? A Systematic Review. Fattorini, L., Rodio, A., Pettorossi, VE., et al.[2023]

Citations

1. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC10443241/

Effectiveness of Focal Muscle Vibration in the Recovery of ... This review aims to show whether this proprioceptive stimulation is useful for optimising the rehabilitative process in the presence of poor motor function.

2. sciencedirect.com sciencedirect.com/science/article/pii/S2590109525000539

Exploring the Impact of Muscle Vibration Therapy in ... Vibration therapy has shown promising outcomes for alleviating pain, managing spasticity, and improving motor function in various neurologic conditions such as ...

3. frontiersin.org frontiersin.org/journals/rehabilitation-sciences/articles/10.3389/fresc.2025.1628749/full

Focal muscle vibration and neurocognitive exercise ... A gradual improvement in pain symptoms was observed, with resolution of allodynia immediately following the first session of focal muscle vibration therapy.

4. clinicaltrials.gov clinicaltrials.gov/study/NCT05322746

Focal Vibrations and Neuropathic Pain in Diabetic ... Improvement of Gait after 4 Weeks of Wearable Focal Muscle Vibration Therapy for Individuals with Diabetic Peripheral Neuropathy. J Clin Med. 2020 Nov 22;9 ...

5. mdpi.com mdpi.com/1660-4601/18/5/2415

Wearable Focal Muscle Vibration on Pain, Balance, ... This study explores the benefits of 4-week, in-home wearable focal muscle vibration (FMV) therapy on pain, balance, mobility, and sensation in people with DPN.

6. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC7967773/

Wearable Focal Muscle Vibration on Pain, Balance, Mobility ... This study explores the benefits of 4-week, in-home wearable focal muscle vibration (FMV) therapy on pain, balance, mobility, and sensation in people with DPN.

7. withpower.com withpower.com/trial/phase-peripheral-nervous-system-diseases-7-2021-2137e

Wearable Focal Vibration for Peripheral Neuropathy A study on wearable focal muscle vibration therapy showed significant improvements in pain, mobility, and sensation for people with diabetic peripheral ...

8. resna.org resna.org/sites/default/files/conference/2020/StudentScientificPapers/NewAndEmergingTechnology/122Chandrashekhar.html

Effect of Focal Muscle Vibration on Pain, Mobility, Balance, ... The preliminary findings confirm the hypothesis that FMV significantly improved TUG, TUG Cognitive, left foot SWMT, and the average pain sub-scale of BPI-DPN.