Trial Outcomes & Findings for Electrical Stimulation Therapy Using the MC5-A Scrambler in Reducing Peripheral Neuropathy Caused by Chemotherapy (NCT NCT00952848)
NCT ID: NCT00952848
Last Updated: 2017-03-29
Results Overview
Change in Neumeric Rating Score for Pain as measured by a Numeric Pain Rating scale between day 0 to day 15. Scale is 0 (none) to 10 (severe)
COMPLETED
PHASE2
18 participants
15 days
2017-03-29
Participant Flow
Dates of recruitment: 06/12/2009 - 10/26/2009 Location of recruitment: medical clinic
Participant milestones
| Measure |
MC5-A Scrambler Instrument
Treatment of chronic neuropathic pain with the MC5-A device
|
|---|---|
|
Overall Study
STARTED
|
18
|
|
Overall Study
COMPLETED
|
14
|
|
Overall Study
NOT COMPLETED
|
4
|
Reasons for withdrawal
| Measure |
MC5-A Scrambler Instrument
Treatment of chronic neuropathic pain with the MC5-A device
|
|---|---|
|
Overall Study
Withdrawal by Subject
|
4
|
Baseline Characteristics
Electrical Stimulation Therapy Using the MC5-A Scrambler in Reducing Peripheral Neuropathy Caused by Chemotherapy
Baseline characteristics by cohort
| Measure |
MC5-A Scrambler Instrument
n=18 Participants
Treatment of chronic neuropathic pain with the MC5-A device
|
|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=99 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
18 Participants
n=99 Participants
|
|
Age, Categorical
>=65 years
|
0 Participants
n=99 Participants
|
|
Age, Continuous
|
60 years
STANDARD_DEVIATION 5 • n=99 Participants
|
|
Sex: Female, Male
Female
|
14 Participants
n=99 Participants
|
|
Sex: Female, Male
Male
|
4 Participants
n=99 Participants
|
|
Region of Enrollment
United States
|
18 participants
n=99 Participants
|
PRIMARY outcome
Timeframe: 15 daysPopulation: Patients treated with MC5A devise for 10 consectuvive days
Change in Neumeric Rating Score for Pain as measured by a Numeric Pain Rating scale between day 0 to day 15. Scale is 0 (none) to 10 (severe)
Outcome measures
| Measure |
MC5-A Pain Treatment Device
n=14 Participants
Patients treated with the MC5-A device for chronic chemotherapy-induced peripheral neuropathy
|
|---|---|
|
Change in Pain Score
|
2.4 units on a scale
Interval -3.0 to 6.0
|
SECONDARY outcome
Timeframe: 2 weeksPopulation: Patients treated with MC5A devise for 10 consectuvive days
Change on pain and neuropathy as measured by the Eastern Cooperative Oncology Group (ECOG) Common Toxicity Criteria for Sensory Neuropathy scale,0=none to 4=paralysis; the World Health Organization (WHO) Classification Scale, 0=none to 4=paralysis; and the Brief Pain Inventory-Short Form, 0=none to 4=most intense pain imaginable. Scores will be averaged.
Outcome measures
| Measure |
MC5-A Pain Treatment Device
n=14 Participants
Patients treated with the MC5-A device for chronic chemotherapy-induced peripheral neuropathy
|
|---|---|
|
Effect of MC5-A on Pain and Neuropathy
|
1.3 units on a scale
Interval 0.083 to 2.35
|
SECONDARY outcome
Timeframe: 2 weeksPopulation: Patients treated with MC5A devise for 10 consectuvive days
The change in overal equivalent doses (all narcotic doses will be converted to morphine oral equivalent doses ie as mg/24hours. (All opiates taken will be recorded for the full 24 hours preceding the visit or phone call. All opiates will be converted to the pnmorphine equivalent using the Morphine oral dose equivalents (MOED). The total MOEDs taken during the 24 hours will be the sum of all opiates taken) used before intervention
Outcome measures
| Measure |
MC5-A Pain Treatment Device
n=14 Participants
Patients treated with the MC5-A device for chronic chemotherapy-induced peripheral neuropathy
|
|---|---|
|
Effect of MC5-A on Morphine Oral Equivalent Doses Used Before and After MC5-A Therapy
|
-41.25 mg/24hr
Interval -45.38 to -37.12
|
SECONDARY outcome
Timeframe: 2 weeksPopulation: Patients treated with MC5A devise for 10 consectuvive days
Change on global quality of life. The global quality of life will improve as measured by the Uniscale Linear Analog Scale Assessment (LASA) quality of life scale 0=as bad as it can be to 10=as good as it can be. Scores will be averaged.
Outcome measures
| Measure |
MC5-A Pain Treatment Device
n=14 Participants
Patients treated with the MC5-A device for chronic chemotherapy-induced peripheral neuropathy
|
|---|---|
|
Toxicity of MC5-A Therapy on Global Quality of Life Using the Uniscale Instrument
|
0.08 units on a scale
Interval 0.0 to 10.0
|
Adverse Events
MC5-A Scrambler Instrument
Serious adverse events
| Measure |
MC5-A Scrambler Instrument
n=18 participants at risk
Treatment of chronic neuropathic pain with the MC5-A device
|
|---|---|
|
Nervous system disorders
Seizure
|
5.6%
1/18 • Number of events 1 • 6 months
|
Other adverse events
Adverse event data not reported
Additional Information
Thomas J. Smith, MD, FACP
Virginia Commonwealth University
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place