Vibration Therapy for Peripheral Neuropathy

Recruiting at 2 trial locations

Overseen By Lacy Slayton

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: Indiana University

Disqualifiers: Pre-existing neuropathy, Diabetes, others

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

Compensation: Varies

Number of Visits: 5

Duration: 4 weeks

16 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial examines whether a simple, daily vibration therapy can alleviate numbness or tingling in the hands from past chemotherapy. The goal is to determine if holding a small, vibrating device for three minutes each day can improve these symptoms and enhance daily life. The researchers aim to assess if this therapy is safe, effective, and merits further study. Suitable participants have completed chemotherapy at least 60 days ago and still experience noticeable symptoms in their hands.

As an unphased trial, this study offers participants the chance to contribute to groundbreaking research that could lead to new treatment options for chemotherapy-induced symptoms.

Will I have to stop taking my current medications?

The trial information does not specify whether you need to stop taking your current medications. It is best to discuss this with the trial coordinators or your doctor.

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

Research is examining the safety and effectiveness of hand-held vibration therapy for treating chemotherapy-induced peripheral neuropathy (CIPN). This therapy involves using a vibrating device on each hand for just 3 minutes a day. Although clear data on its safety is not yet available, its inclusion in a clinical trial suggests it is considered safe enough for study.

Specific reports of side effects have not emerged, indicating that this therapy is likely well-tolerated. As a non-invasive treatment, vibration therapy generally poses fewer risks than medications. However, the trial remains in its early stages, aiming to gather more definitive information on safety and effectiveness. While early results may appear promising, further research is necessary to confirm them. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Unlike the standard treatments for peripheral neuropathy, which often involve medications like pain relievers, antidepressants, or anti-seizure drugs, hand-held vibration therapy offers a non-drug approach to symptom management. This treatment is unique because it uses a simple vibrating device that patients can easily use at home, potentially reducing reliance on medications and their side effects. Researchers are excited about this therapy because it provides a new, non-invasive way to address nerve pain and discomfort, possibly offering relief in just a few minutes of use each day.

What evidence suggests that hand-held vibration therapy is effective for reducing CIPN?

Research shows that vibration therapy might help lessen the symptoms of peripheral neuropathy, a form of nerve damage. One study on diabetic neuropathy found that local vibration therapy improved nerve function. In this trial, participants will use a hand-held vibration device daily to potentially reduce symptoms in the hands caused by chemotherapy-related nerve damage. Although data for chemotherapy-related nerve damage remains limited, the potential benefits of vibration therapy appear promising based on similar conditions. Early findings suggest it may enhance the quality of life for those with neuropathy. ^{1 2 3 4 6}

Who Is on the Research Team?

Erin Newton, MD

Principal Investigator

Indiana University

Are You a Good Fit for This Trial?

This trial is for adults who finished chemotherapy at least 60 days ago, have ongoing hand neuropathy from the treatment, and can consent to participate. They must not have metastatic cancer or other causes of neuropathy like diabetes or carpal tunnel syndrome. Participants agree to regular clinic visits.

Inclusion Criteria

Agree to return to clinic for required study related measurements at specified intervals

My solid tumor cancer has not spread to other parts of my body.

I have been treated with high doses of chemotherapy that can affect the nerves.

Exclusion Criteria

I have nerve pain in my hands not caused by chemotherapy.

I don't have blood clots or skin infections in my arms that prevent vibration therapy.

I have been diagnosed with diabetes.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive daily 3-minute hand-held vibration therapy for 4 weeks

4 weeks

Weekly assessments (virtual or in-person)

Follow-up

Participants are monitored for changes in CIPN severity and quality of life

4 weeks

Assessments at weeks 5, 6, 7, and 8

What Are the Treatments Tested in This Trial?

Interventions

• Hand-Held Vibration Therapy

Trial Overview The study tests a daily 3-minute vibration therapy on hands to see if it's safe and can lessen nerve pain caused by chemotherapy (CIPN). The goal is also to check if this improves life quality related to CIPN, setting the stage for future trials.

How Is the Trial Designed?

Group I: Vibration Therapy Experimental Treatment 1 Intervention

Patients will hold a hand held vibrating device for 3 minutes on each hand daily for 4 weeks.

Who Is Running the Clinical Trial?

Indiana University

Lead Sponsor

Trials

1,063

Recruited

1,182,000+

Indiana Clinical and Translational Sciences Institute

Collaborator

Trials

20

Recruited

4,400+

Published Research Related to This Trial

In a preliminary trial involving 10 patients with unilateral leg lymphedema, a combined therapy using magnetic fields, vibration, and hyperthermia over 20 days resulted in significant improvements, with 8 patients showing highly effective outcomes.

The treatment led to the volume of the affected leg nearly matching that of the healthy leg in 6 cases, indicating strong efficacy, although one patient experienced temporary skin erythema, which resolved on its own.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Treatment of peripheral lymphedema by concomitant application of magnetic fields, vibration and hyperthermia: a preliminary report. Ohkuma, M.[2006]

Local vibration therapy applied to the feet significantly reduced pain severity in a patient with diabetic peripheral neuropathy (DPN) by 62.5% after five treatment sessions.

The treatment also improved protective sensation, normalized vibration thresholds, and enhanced blood flow and balance, as indicated by increased skin temperature and a six-point improvement in balance scores.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Local plantar vibration for the treatment of diabetic neuropathy: a case report. Sabziparvar, M., Naghdi, S., Ansari, NN., et al.[2022]

A 12-week self-administered weight lifting program for patients with breast cancer-related arm lymphedema was found to be feasible and safe, with excellent adherence reported among the 23 participants who trained three times a week.

The program led to significant improvements in shoulder and arm strength and a reduction in excess arm volume, indicating potential benefits for managing lymphedema symptoms.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A home-based weight lifting program for patients with arm lymphedema following breast cancer treatment: a pilot and feasibility study. Johansson, K., Klernäs, P., Weibull, A., et al.[2014]

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]

Whole-body vibration training significantly improved vibration perception thresholds in type 2 diabetic patients with peripheral neuropathy, based on a study involving 59 participants over 6 weeks.

In contrast, the control group that only performed lower body training showed no significant changes in perception thresholds, indicating the specific benefits of whole-body vibration training.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Effects of whole-body vibration therapy on perception thresholds of type 2 diabetic patients with peripheral neuropathy: a randomized controlled trial. Lee, K.[2020]

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]

Aqua therapy resistance exercise significantly reduced arm volume and pain intensity while improving shoulder range of motion in breast cancer survivors with lymphedema, compared to traditional land-based exercises, after 8 weeks of treatment.

The study involved 50 participants, with results showing a marked improvement in limb volume, shoulder flexion, and abduction range of motion, indicating that aqua therapy may be a more effective intervention for managing post-mastectomy lymphedema.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Effect of Aqua Therapy Exercises on Postmastectomy Lymphedema: A Prospective Randomized Controlled Trial. Ali, KM., El Gammal, ER., Eladl, HM.[2021]

Whole body vibration therapy (WBV) significantly reduced pain in participants with diabetic peripheral neuropathy (DPN), as measured by the visual analog pain scale (VAS) and neuropathic pain scale (NPS), after three sessions per week for four weeks.

The study involved 8 participants and found no side effects, suggesting that WBV is a safe and effective non-invasive treatment option for managing pain associated with DPN.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Whole body vibration therapy for painful diabetic peripheral neuropathy: a pilot study. Kessler, NJ., Hong, J.[2022]

The pilot study involving 21 women breast cancer survivors with lymphedema showed that Bowenwork therapy was safe and well-accepted, with a 95% completion rate and no adverse events reported.

Participants experienced significant improvements in mental health, functional status, range of motion, and reductions in arm circumference, indicating that Bowenwork may enhance quality of life for these survivors.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Bowenwork for symptom management of women breast cancer survivors with lymphedema: A pilot study. Argenbright, CA., Taylor-Piliae, RE., Loescher, LJ.[2017]

Whole Body Vibration (WBV) therapy significantly reduced chronic pain associated with diabetic peripheral neuropathy (DPN) in a study of 20 participants over four weeks, with pain scores decreasing notably at both 2 and 4 weeks after treatment.

The study, which included a sham control to ensure validity, found that the pain relief from WBV persisted even after treatment ended, suggesting a potential long-term benefit of this therapy for managing DPN-related pain.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Whole body vibration improves symptoms of diabetic peripheral neuropathy. Kessler, NJ., Lockard, MM., Fischer, J.[2021]

A 64-year-old male with chronic diabetic peripheral neuropathic pain experienced significant improvement in pain levels and gait after 4 weeks of whole body vibration therapy, following unsuccessful trials with conventional medications and interventional treatments.

This case suggests that whole body vibration therapy could be a valuable complementary treatment option for patients suffering from diabetic peripheral neuropathic pain, especially when other treatments have failed.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Case study: use of vibration therapy in the treatment of diabetic peripheral small fiber neuropathy. Hong, J., Barnes, M., Kessler, N.[2022]

Breast cancer survivors experience unmet needs for support and information during home rehabilitation after surgery, highlighting the potential for mobile health (mHealth) systems to provide necessary assistance.

Participants expressed a desire for a reliable mHealth tool that offers exercise support, as current options are lacking and often not tailored to their specific rehabilitation needs.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Patient Experiences of Rehabilitation and the Potential for an mHealth System with Biofeedback After Breast Cancer Surgery: Qualitative Study. Brennan, L., Kessie, T., Caulfield, B.[2021]

Citations

1. clinicaltrial.be clinicaltrial.be/en/details/59268?per_page=100&only_recruiting=0&only_eligible=0&only_active=0

Daily Hand-Held Vibration Therapy The investigators hypothesize that daily vibration therapy can reduce the severity of patient's CIPN in their hands and improve CIPN-related ...

2. centerwatch.com centerwatch.com/clinical-trials/listings/NCT04207437/daily-hand-held-vibration-therapy

Daily Hand-Held Vibration Therapy The investigators hypothesize that daily vibration therapy can reduce the severity of patient's CIPN in their hands and improve CIPN-related ...

3. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC8630268/

Local plantar vibration for the treatment of diabetic ... In this study, we aimed to evaluate the effectiveness of local vibration in treating a patient with DPN.

4. ancora.ai ancora.ai/en/details/NCT04207437

Daily Hand-Held Vibration Therapy (NCT04207437) The investigators hypothesize that daily vibration therapy can reduce the severity of patient's CIPN in their hands and improve CIPN-related quality of life.

5. withpower.com withpower.com/trial/phase-kidney-diseases-1-2020-5e2af

Vibration Therapy for Peripheral Neuropathy The investigators hypothesize that daily vibration therapy can reduce the severity of patient's CIPN in their hands and improve CIPN-related quality of life.

6. cancer.gov cancer.gov/research/participate/clinical-trials-search/v?id=NCI-2019-07399

Daily Hand-Held Vibration Therapy for the Reduction of ... This trial studies the side effects of daily hand-held vibration therapy and to see how well it works in reducing chemotherapy induced peripheral neuropathy ...