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)

Recruitment status

COMPLETED

Study phase

PHASE2

Target enrollment

18 participants

Primary outcome timeframe

15 days

Results posted on

2017-03-29

Participant Flow

Dates of recruitment: 06/12/2009 - 10/26/2009 Location of recruitment: medical clinic

Participant milestones

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

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

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 days

Population: 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

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 weeks

Population: 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

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 weeks

Population: 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

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 weeks

Population: 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

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 events: 1 serious events
Other events: 0 other events
Deaths: 0 deaths

Serious adverse events

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

Phone: 410-955-2091

Results disclosure agreements

  • Principal investigator is a sponsor employee
  • Publication restrictions are in place