Whole Body Vibration for Peripheral Neuropathy

Overseen By Kerri Winters-Stone, PhD

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: OHSU Knight Cancer Institute

Disqualifiers: Metastases, Weight > 275 pounds, 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: Unknown

Duration: 12 weeks

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial explores whether whole body vibration (WBV) therapy can help individuals with chemotherapy-induced peripheral neuropathy, a condition causing numbness, tingling, or pain in the hands and feet after cancer treatment. The researchers aim to determine if WBV can improve mobility, reduce pain, and potentially aid weight loss. Participants will either receive WBV treatment or continue with their usual care for comparison. This trial may suit cancer survivors who have experienced neuropathy symptoms after chemotherapy within the last five years. As an unphased trial, it offers a unique opportunity to explore innovative therapies that could enhance the quality of life for cancer survivors.

Will I have to stop taking my current medications?

The trial protocol does not specify whether you need to stop taking your current medications. However, if your medication use contraindicates (goes against) participation in low intensity exercise or whole body vibration, you may be considered ineligible.

What prior data suggests that whole body vibration is safe for improving health in participants with chemotherapy-induced peripheral neuropathy?

Research shows that whole body vibration (WBV) is generally safe. Studies have found that WBV can safely build bone in people with low bone density without medication. It also serves as a safe exercise option for older adults, enhancing strength and balance. Some WBV machines include safety features like handrails for added support.

However, some readily available WBV devices might not meet safety standards, so using the right equipment is important. Overall, WBV is considered safe for most people, but following guidelines and using equipment designed with safety in mind is crucial. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about whole body vibration (WBV) as a potential treatment for chemotherapy-induced peripheral neuropathy because it offers a unique, non-invasive approach compared to existing options like medications and physical therapy. Unlike traditional treatments that primarily focus on symptom management, WBV uses mechanical vibrations to possibly improve nerve function and reduce pain through gentle physical exercises. This innovative method could lead to enhanced quality of life for patients by potentially providing faster relief and increased mobility without the side effects often associated with medication.

What evidence suggests that whole body vibration is effective for improving health and functioning in participants with chemotherapy-induced peripheral neuropathy?

Research shows that whole body vibration (WBV), which participants in this trial may receive, can enhance muscle strength and physical performance, potentially benefiting those with chemotherapy-induced peripheral neuropathy (CIPN). Studies have found that WBV aids in weight loss, improves mobility, and reduces pain, making it promising for individuals experiencing numbness or tingling in their hands and feet due to CIPN. Clinical trials have found WBV to be safe and effective, with improvements observed in conditions like knee osteoarthritis, suggesting it might also help with CIPN. While more research is needed to understand exactly how WBV affects CIPN, early results about its ability to relieve pain and improve movement are encouraging. ^{3 6 7 8 9}

Who Is on the Research Team?

Kerri Winters-Stone, PhD

Principal Investigator

OHSU Knight Cancer Institute

Are You a Good Fit for This Trial?

Inclusion Criteria

Previous chemotherapy within five years of enrollment (confirmed by self-report on the Health History Questionnaire. If the patient is unable to confirm, we will send a letter to their physician to confirm for this criterion)

Presence of mild-very severe CIPN symptoms (confirmed by assessment using the Patient-Reported Outcomes [PRO]-Common Terminology Criteria for Adverse Events [CTCAE] criteria)

Histologically confirmed cancer stage I-IIIc (confirmed by self-report on the Health History Questionnaire. If the patient is unable to confirm, we will send a letter to their physician to confirm for this criterion)

Exclusion Criteria

Body weight > 275 pounds (confirmed by self-report on the Health History Questionnaire)

A medical condition, movement or neurological disorder, or medication use that contraindicates participation in low intensity exercise and/or WBV (confirmed by self-report on the Health History Questionnaire, and by physician clearance, if in the professional opinion of the Principal Investigator, Dr. Kerri Winters-Stone, contraindications other than those identified by the patient or physician are present, she may consider the participant ineligible.)

Presence of any known metastases (confirmed by self-report on the Health History Questionnaire. If the patient is unable to confirm, we will send a letter to their physician to confirm for this criterion)

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive whole body vibration (WBV) sessions or usual care for 12 weeks

12 weeks

Daily sessions for WBV group

Follow-up

Participants are monitored for safety and effectiveness after treatment

12 weeks

What Are the Treatments Tested in This Trial?

Interventions

• Whole Body Vibration

How Is the Trial Designed?

Group I: Whole body vibration (WBV) Experimental Treatment 1 Intervention

Participants assigned to the WBV group will participate in twice daily 10-minute WBV training sessions, 7 days a week. Each WBV session will consist of a series of timed stands on the vibration platform (Marodyne LiV). During a timed stand, participants will perform slow controlled weight shifting exercises and gentle squats. The vibration frequency will be set at 30Hz and the amplitude set at 50-200 microns, for a total body acceleration of 0.4g+/-20%.

Group II: Usual Care (UC) Active Control 1 Intervention

Participants randomly assigned to the UC group will serve as controls and will be tested at the same time points as the WBV group. The UC group will be asked not to change their physical activity or dietary habits across the intervention period and we will track any changes using a questionnaire.

Whole Body Vibration is already approved in United States, European Union for the following indications:

Approved in United States as Whole Body Vibration for:

• Rehabilitation following anterior cruciate ligament reconstruction surgery (ACLR)
• Improvement of quadriceps muscle function
• Enhancement of gait biomechanics
• Reduction of post-traumatic knee osteoarthritis risk

Approved in European Union as Whole Body Vibration for:

• Rehabilitation following ACLR
• Improvement of neuromuscular performance
• Enhancement of proprioception and postural stability

Who Is Running the Clinical Trial?

OHSU Knight Cancer Institute

Lead Sponsor

Trials

239

Recruited

2,089,000+

Oregon Health and Science University

Collaborator

Trials

1,024

Recruited

7,420,000+

Published Research Related to This Trial

In a study involving 15 individuals with multiple sclerosis, high-frequency whole-body vibration (26 Hz) showed a consistent trend of higher isometric muscle torque in the quadriceps and hamstrings compared to low-frequency vibration (2 Hz), although these differences were not statistically significant.

The results suggest that while high-frequency WBV may enhance muscle performance, further research is needed to explore its potential as a treatment option and to assess its long-term effects and functional outcomes.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Acute effects of whole-body vibration on lower extremity muscle performance in persons with multiple sclerosis. Jackson, KJ., Merriman, HL., Vanderburgh, PM., et al.[2009]

Whole-body vibration training (WBVT) can lead to potentially harmful levels of vibration exposure, exceeding safety standards set by ISO 2631-1, even with just 10 minutes of training per day.

The study found that performing slow, unloaded squats during WBVT with vertical forces (VV) resulted in greater head acceleration and mechanical impedance compared to using upward forces on one foot at a time (RV), suggesting that RV may pose a lower risk of adverse health effects.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Vibration exposure and biodynamic responses during whole-body vibration training. Abercromby, AF., Amonette, WE., Layne, CS., et al.[2022]

Whole-body vibration (WBV) is gaining attention as a potential therapy to enhance neuromuscular performance and increase bone mass or density.

The International Society of Musculoskeletal and Neuronal Interactions (ISMNI) has provided expert recommendations to improve the quality and consistency of reports on WBV treatment studies.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Reporting whole-body vibration intervention studies: recommendations of the International Society of Musculoskeletal and Neuronal Interactions. Rauch, F., Sievanen, H., Boonen, S., et al.[2022]

Citations

1. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC8226869/

Effectiveness of Whole-Body Vibration Training to Improve ... This clinical trial investigates the efficacy of WBVT in improving muscle strength and physical performance before resistance exercise.

2. vibrotherapy.pro vibrotherapy.pro/studies-and-reports/metabolism/after-21-days-of-oscillatory-cycloid-vibration-therapy-for-women-over-65-improvements-in-lipidogram-indices-were-observed/

After 21 days of oscillatory-cycloid vibration therapy for women ... Its beneficial effects on body weight change, glucose tolerance, muscle fibre status and liver function and steatosis parameters were indicated.

3. bmcmusculoskeletdisord.biomedcentral.com bmcmusculoskeletdisord.biomedcentral.com/articles/10.1186/s12891-023-06334-9

Effect of low-magnitude, variable-frequency vibration therapy ... Our data demonstrated that the use of vibrations of variable frequency and low amplitude in patients with the knee OA is a safe and effective therapy.

4. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC11396361/

The Clinical Utility of Whole Body Vibration - PubMed Central This review will provide an overview of the different types of WBV and the dose parameters that contribute to the efficacy of use in metabolic disease.

5. trial.medpath.com trial.medpath.com/clinical-trial/e10e131ccba639d8/nct04611451-effect-whole-body-vibration-exercises-chronic-low-back-pain

Effect of Whole Body Vibration Exercises for Patients wıth ... Different protocols are used for wbv exercise in studies (6). Our aim is to compare the effects of whole body vibration exercise modality on pain, functional ...

6. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC3688642/

Safety and severity of accelerations delivered from whole ... This work indicates that readily accessible WBV devices markedly exceed ISO guidelines for safety, and extreme caution must be practiced when considering their ...

7. youtube.com youtube.com/watch?v=gvtHKCdqdKM

Is Whole Body Vibration Platform Safe to Use? liv is a non-drug treatment strategy that builds bone it's been shown to successfully and safely build bone in persons diagnosed with osteopenia.

8. effectivehealthcare.ahrq.gov effectivehealthcare.ahrq.gov/sites/default/files/pdf/osteoporosis-vibration-therapy_technical-brief.pdf

Whole-Body Vibration Therapy for Osteoporosis Some platforms have safety features, such as a handrail for balance. Low-intensity vibration platforms are currently marketed for home use for about $1,600.

9. sciencedirect.com sciencedirect.com/topics/medicine-and-dentistry/whole-body-vibration

Whole Body Vibration - an overview Whole-body vibration is found to be a safe and easy exercise tool for the elderly. •. It is effective in improving various neuromuscular parameters in KOA ...