Whole Body Vibration for the Improvement of Health and Functioning in Participants With Chemotherapy-Induced 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

38 Participants Needed

Trial Summary

What is the purpose of this trial?

This trial studies if whole body vibration can help cancer survivors who have nerve damage from chemotherapy. The treatment involves standing on a vibrating machine to improve movement and reduce pain. The goal is to see if this method is safe and effective for these patients.

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 data supports the effectiveness of the treatment Whole Body Vibration, Whole Body Vibration, WBV, Local Muscle Vibration, LMV, Vibration Therapy, Oscillatory-Cycloidal Vibrotherapy?

Research shows that Whole Body Vibration (WBV) can help reduce pain and improve strength in people with chronic knee osteoarthritis and may also benefit those with fibromyalgia by improving pain, function, and mood. Additionally, WBV has been studied for its potential to reduce fat mass in overweight and obese adults. ^{1 2 3 4 5}

Is whole body vibration therapy safe for humans?

Whole body vibration therapy (WBV) is generally considered safe for humans, but excessive or chronic exposure can lead to negative effects on the skeletal, digestive, reproductive, visual, and balance systems. ^{4 6 7 8 9}

How is Whole Body Vibration therapy different from other treatments?

Whole Body Vibration (WBV) therapy is unique because it involves standing on a vibrating platform, which stimulates muscle spindles and alpha-motoneurons to initiate muscle contractions, potentially increasing muscle strength, balance, and bone mass. Unlike traditional exercises, WBV can provide these benefits through vibrations, making it a novel approach for conditions like stroke rehabilitation and muscle performance improvement. ^{10 11 12 13 14}

Research Team

Kerri Winters-Stone, PhD

Principal Investigator

OHSU Knight Cancer Institute

Eligibility Criteria

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)

Age 18 years or older at enrollment (confirmed by self-report on the Health History Questionnaire)

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

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

Treatment Details

Interventions

• Whole Body Vibration

Participant Groups

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+

Findings from Research

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]

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]

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]

References

1. Korea (South) pubmed.ncbi.nlm.nih.gov

Therapeutic effect of whole body vibration on chronic knee osteoarthritis. [2022]

2. England pubmed.ncbi.nlm.nih.gov

Effects of whole body vibration therapy in pain, function and depression of the patients with fibromyalgia. [2018]

3. Germany pubmed.ncbi.nlm.nih.gov

Metabolic responses to whole-body vibration: effect of frequency and amplitude. [2022]

4. England pubmed.ncbi.nlm.nih.gov

Does whole body vibration therapy assist in reducing fat mass or treating obesity in healthy overweight and obese adults? A systematic review and meta-analyses. [2021]

5. United States pubmed.ncbi.nlm.nih.gov

Whole-body vibration and blood flow and muscle oxygenation: a meta-analysis. [2018]

6. Greece pubmed.ncbi.nlm.nih.gov

Reporting whole-body vibration intervention studies: recommendations of the International Society of Musculoskeletal and Neuronal Interactions. [2022]

7. United States pubmed.ncbi.nlm.nih.gov

Vibration exposure and biodynamic responses during whole-body vibration training. [2022]

8. Netherlands pubmed.ncbi.nlm.nih.gov

Stochastic resonance therapy in Parkinson's disease. [2011]

9. England pubmed.ncbi.nlm.nih.gov

Efficacy of whole body vibration therapy on pain and functional ability in people with non-specific low back pain: a systematic review. [2020]

10. Sweden pubmed.ncbi.nlm.nih.gov

Stochastic resonance therapy induces increased movement related caudate nucleus activity. [2018]

11. England pubmed.ncbi.nlm.nih.gov

Vibration therapy. [2009]

12. England pubmed.ncbi.nlm.nih.gov

The effect of a whole-body vibration therapy on the sitting balance of subacute stroke patients: a randomized controlled trial. [2018]

13. Greece pubmed.ncbi.nlm.nih.gov

Whole-body vibration therapy does not improve the peripheral nerve regeneration in experimental model. [2021]

14. United States pubmed.ncbi.nlm.nih.gov

Acute effects of whole-body vibration on lower extremity muscle performance in persons with multiple sclerosis. [2009]