Focal vibration therapy for Peripheral Neuropathy

Phase-Based Progress Estimates
College of Allied Health, University of Oklahoma Health Sciences Center, Oklahoma City, OKPeripheral NeuropathyFocal vibration therapy - Device
All Sexes
What conditions do you have?

Study Summary

This trial tests how vibration can reduce nerve pain in cancer patients.

Eligible Conditions
  • Chemotherapy-induced Peripheral Neuropathy

Treatment Effectiveness

Effectiveness Progress

1 of 3

Study Objectives

6 Primary · 10 Secondary · Reporting Duration: After 6-week intervention

After 6-week intervention
Adherence to Myovolt focal vibration
After 6-week withdrawal period
Global Rating of Change (GROC) scale
Long-term retention
Feasibility of enrollment
Week 12
Changes in CIPN symptoms and functional impairments as measured by the Functional Assessment of Cancer Therapy/Gynecologic Oncology Group-Neurotoxicity (FACT-GOG/Ntx)
Change from Baseline after 6-week Intervention
Functional Assessment of Cancer Therapy/Gynecologic Oncology Group-Neurotoxicity-12 (FACT-GOG/NTX-12) Functional Well-Being Subscale
Functional Assessment of Cancer Therapy/Gynecologic Oncology Group-Neurotoxicity-12 (FACT-GOG/NTX-12) Physical Well-Being Subscale
Functional Assessment of Cancer Therapy/Gynecologic Oncology Group-Neurotoxicity-12 (FACT-GOG/NTX-12) Symptom Inventory
Manual Muscle Testing (MMT) of Toes
Neuropathy Total Symptom Score-6 (NTSS-6)
Patient Neurotoxicity Questionnaire (PNQ)
Toe Strength using a quantifiable toe measurement device
Vibration Perception Threshold using Biothesiometer
Week 12
Changes in neuropathic symptoms as measured by the Neuropathy Total Symptom Score-6 (NTSS-6)
Week 12
Changes in patient-perspective neuropathy symptoms assessed by the Global Rating of Change Items (GROC) scale
Week 12
Changes in the extent of motor and sensory neuropathy as assessed by the Patient Neurotoxicity Questionnaire 3-item (PNQ)

Trial Safety

Safety Progress

1 of 3

Trial Design

1 Treatment Group

Focal vibration therapy
1 of 1

Experimental Treatment

15 Total Participants · 1 Treatment Group

Primary Treatment: Focal vibration therapy · No Placebo Group · Phase 1

Focal vibration therapy
Experimental Group · 1 Intervention: Focal vibration therapy · Intervention Types: Device

Trial Logistics

Trial Timeline

Screening: ~3 weeks
Treatment: Varies
Reporting: after 6-week intervention

Who is running the clinical trial?

University of OklahomaLead Sponsor
426 Previous Clinical Trials
98,237 Total Patients Enrolled
Hongwu Wang, PhDPrincipal InvestigatorUniversity of Oklahoma
2 Previous Clinical Trials
4 Total Patients Enrolled
Elizabeth Hile, PhDPrincipal InvestigatorUniversity of Oklahoma

Eligibility Criteria

Age 18+ · All Participants · 6 Total Inclusion Criteria

Mark “Yes” if the following statements are true for you:
If you take pain medication, you must keep taking the same amount as you did for the two weeks before the study. You cannot make big changes to your pain medication while participating in the study, and you must let the study team know if you do make any changes.