16 Participants Needed

Vibration Therapy for Peripheral Neuropathy

Recruiting at 2 trial locations
MM
NK
MP
LS
Overseen ByLacy Slayton
Age: 18+
Sex: Any
Trial Phase: Academic
Sponsor: Indiana University
No Placebo GroupAll trial participants will receive the active study treatment (no placebo)

What You Need to Know Before You Apply

What is the purpose of this trial?

The purpose of this pilot study is to determine the safety and feasibility of a daily 3-minute hand-held vibration therapy intervention to reduce the severity of CIPN in the hands. 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. The hope is that results from this study will provide early data on the feasibility, efficacy, and most importantly, safety, of daily 3-minute hand-held vibration therapy needed to justify future clinical trials examining vibration therapy as a potential option for treating CIPN in the future.

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.

Is vibration therapy safe for humans?

In a study involving vibration therapy for lymphedema, one patient experienced skin redness that went away on its own after the therapy ended, suggesting that vibration therapy is generally safe with minor, temporary side effects.12345

How is Hand-Held Vibration Therapy different from other treatments for peripheral neuropathy?

Hand-Held Vibration Therapy is unique because it uses targeted vibrations to potentially relieve pain and improve symptoms, unlike conventional treatments that often involve medications with questionable effectiveness and side effects. This therapy is non-invasive and can be administered at home, offering a novel approach compared to whole-body vibration therapies that require specialized equipment.678910

What data supports the effectiveness of the treatment Hand-Held Vibration Therapy for Peripheral Neuropathy?

Research on whole-body vibration therapy, a similar treatment, shows it can reduce pain and improve balance and quality of life in people with diabetic peripheral neuropathy. This suggests that hand-held vibration therapy might also help with these symptoms.6781112

Who Is on the Research Team?

EN

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.
See 3 more

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.
See 1 more

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?
1Treatment groups
Experimental Treatment
Group I: Vibration TherapyExperimental Treatment1 Intervention
Patients will hold a hand held vibrating device for 3 minutes on each hand daily for 4 weeks.

Find a Clinic Near You

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

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.
Whole body vibration therapy for painful diabetic peripheral neuropathy: a pilot study.Kessler, NJ., Hong, J.[2022]
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.
Local plantar vibration for the treatment of diabetic neuropathy: a case report.Sabziparvar, M., Naghdi, S., Ansari, NN., 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.
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]

Citations

Whole body vibration therapy for painful diabetic peripheral neuropathy: a pilot study. [2022]
Local plantar vibration for the treatment of diabetic neuropathy: a case report. [2022]
Whole body vibration showed beneficial effect on pain, balance measures and quality of life in painful diabetic peripheral neuropathy: a randomized controlled trial. [2022]
Effects of whole-body vibration therapy on perception thresholds of type 2 diabetic patients with peripheral neuropathy: a randomized controlled trial. [2020]
Effects of vibrating insoles on standing balance in diabetic neuropathy. [2022]
Effect of Aqua Therapy Exercises on Postmastectomy Lymphedema: A Prospective Randomized Controlled Trial. [2021]
A home-based weight lifting program for patients with arm lymphedema following breast cancer treatment: a pilot and feasibility study. [2014]
Patient Experiences of Rehabilitation and the Potential for an mHealth System with Biofeedback After Breast Cancer Surgery: Qualitative Study. [2021]
Bowenwork for symptom management of women breast cancer survivors with lymphedema: A pilot study. [2017]
10.United Statespubmed.ncbi.nlm.nih.gov
Treatment of peripheral lymphedema by concomitant application of magnetic fields, vibration and hyperthermia: a preliminary report. [2006]
11.United Statespubmed.ncbi.nlm.nih.gov
Whole body vibration improves symptoms of diabetic peripheral neuropathy. [2021]
12.United Statespubmed.ncbi.nlm.nih.gov
Case study: use of vibration therapy in the treatment of diabetic peripheral small fiber neuropathy. [2022]
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