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Trial Outcomes & Findings for Study of PM Modulation Therapy in Trial Phase (NCT NCT03110601)

NCT ID: NCT03110601

Last Updated: 2019-04-16

Results Overview

Numerical rating pain score measured before and after intervention. 11-point Numeric Pain Rating Scale (NPRS) with 0 being no pain at all and 10 being the worst pain imaginable (1-3 is rated as mild pain, 4-6 is rated at moderate pain, 7-9 is rated as severe pain). Subject rates average pain for the past 7 days.

Recruitment status

COMPLETED

Study phase

NA

Target enrollment

25 participants

Primary outcome timeframe

Baseline and 4 days plus or minus 1 days

Results posted on

2019-04-16

Participant Flow

Non-randomized cross-over study in which all eligible participants received the same order of procedures (i.e. Conventional SCS parameters for 4 days, then a washout period of 1 day, then PM-SCS parameters for 4 days).

Participant milestones

Participant milestones
Measure
Single Arm With Multiple Periods
Non-randomized cross-over study in which all eligible participants received the same order of procedures (i.e. Conventional SCS parameters for 4 days, then a washout period of 1 day, then PM-SCS parameters for 4 days).
Conventional SCS Parameters
STARTED
25
Conventional SCS Parameters
COMPLETED
24
Conventional SCS Parameters
NOT COMPLETED
1
Washout Period
STARTED
24
Washout Period
COMPLETED
23
Washout Period
NOT COMPLETED
1
Stimgenics SCS Parameters
STARTED
23
Stimgenics SCS Parameters
COMPLETED
20
Stimgenics SCS Parameters
NOT COMPLETED
3

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Race and Ethnicity were not collected from any participant.

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure
Enrolled Patients
n=25 Participants
Back pain patients that were trialed with Conventional SCS parameters, then after a washout period the same patients were trialed with PM-SCS parameters (Stimgenics SCS parameters).
Age, Continuous
62.4 years
STANDARD_DEVIATION 11.5 • n=25 Participants
Sex: Female, Male
Female
15 Participants
n=25 Participants
Sex: Female, Male
Male
10 Participants
n=25 Participants
Back Pain on Numeric Pain Rating Scale (11-point rating scale)
7.4 Score on a scale
STANDARD_DEVIATION 1.2 • n=25 Participants
Leg Pain Numeric Pain Rating Scale (11-point rating scale)
4 Score on a scale
STANDARD_DEVIATION 2.8 • n=25 Participants

PRIMARY outcome

Timeframe: Baseline and 4 days plus or minus 1 days

Population: Chronic Back Pain Patients with or without leg pain; 4 subjects experience known adverse events (such as lead migration) that prevented them from testing Stimgenics SCS.

Numerical rating pain score measured before and after intervention. 11-point Numeric Pain Rating Scale (NPRS) with 0 being no pain at all and 10 being the worst pain imaginable (1-3 is rated as mild pain, 4-6 is rated at moderate pain, 7-9 is rated as severe pain). Subject rates average pain for the past 7 days.

Outcome measures

Outcome measures
Measure
Conventional SCS
n=24 Participants
Mean Back Pain Score after treatment Conventional SCS parameters
Stimgenics SCS
n=20 Participants
Mean Back Pain Score after treatments with Stimgenics SCS parameters
Change in Pain Relative to Baseline and After a Trial Period
4.2 Score on a 11 point scale
Standard Deviation 2.0
2.4 Score on a 11 point scale
Standard Deviation 1.8

Adverse Events

Conventional SCS

Serious events: 1 serious events
Other events: 3 other events
Deaths: 0 deaths

Washout Period

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

Stimgenics SCS

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

Serious adverse events

Serious adverse events
Measure
Conventional SCS
n=25 participants at risk
Conventional SCS parameters for 4 days
Washout Period
n=20 participants at risk
Washout period of 1 day
Stimgenics SCS
n=20 participants at risk
Stimgenics SCS parameters for 4 days
Infections and infestations
Epidural abscess
4.0%
1/25 • Number of events 1 • 1-10 days
Same as clinicaltrials.gov definition
0.00%
0/20 • 1-10 days
Same as clinicaltrials.gov definition
0.00%
0/20 • 1-10 days
Same as clinicaltrials.gov definition

Other adverse events

Other adverse events
Measure
Conventional SCS
n=25 participants at risk
Conventional SCS parameters for 4 days
Washout Period
n=20 participants at risk
Washout period of 1 day
Stimgenics SCS
n=20 participants at risk
Stimgenics SCS parameters for 4 days
Surgical and medical procedures
Lead movement
12.0%
3/25 • Number of events 3 • 1-10 days
Same as clinicaltrials.gov definition
0.00%
0/20 • 1-10 days
Same as clinicaltrials.gov definition
0.00%
0/20 • 1-10 days
Same as clinicaltrials.gov definition

Additional Information

VP of Clinical Affairs

Stimgenics

Phone: 309-662-4321

Results disclosure agreements

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