Vibration therapy
Devicevibration therapy using hand held vibration device
NCT Number: NCT04207437
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.
Interested in participating?
Request Info18 year and older
All sexes
Interventional
Not applicable
Indiana University Health West, Avon, Indiana, United States
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
vibration therapy using hand held vibration device
Time frame: recruitment period (up to 5 year after study starts)
Time frame: 4 weeks
Compliance with the daily vibration therapy sessions will be evaluated using data from a Daily Compliance Form Researchers will calculate the percentage of sessions that were completed calculated for each participant, on each hand. Participant compliance with the intervention will be considered acceptable if participants complete ≥ 80% of the sessions they were assigned.
Time frame: 4 weeks
percentage of participants who answer "somewhat agree," "agree," or "strongly agree" on the intervention acceptability form
Time frame: baseline, week 1, week 2, week 3, week 4
CIPN 20 questionnaire scores will be compared to baseline weekly to identify an increase of 30% during the intervention period. The CIPN scores range from 20 to 80 with 80 being consistent with the most severe neuropathy symptoms
Time frame: baseline, weeks 1, 2, 3, and 4, 5, 6, 7, and week 8
Summary statistics for the weekly CIPN-20 (n, mean, standard deviation, median, minimum, maximum)
Time frame: baseline, week 4, week 8
Descriptive statistics (frequency and percentage for each category, mean and standard deviation of scores assigned to each category (range: 0-7)) will be used to describe the CIPN-related QOL participants have on each of the three categories related to quality of life
Contact information is provided by the study sponsor or research team.
Cheri West, RN
CONTACT
Lacy Slayton
CONTACT
Indiana University
Other
Daily Hand-Held Vibration Therapy for the Treatment of Chemotherapy Induced Peripheral Neuropathy (CIPN): A Pilot Study
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