Trial Outcomes & Findings for Comparison of 10 kHz SCS Combined With CMM to CMM Alone in the Treatment of Neuropathic Limb Pain (NCT NCT03228420)
NCT ID: NCT03228420
Last Updated: 2021-08-10
Results Overview
Difference between treatment groups in responder rates in subjects without a clinically meaningful neurological deficit compared with baseline. Responder is defined as a subject who has at least 50% reduction in lower limb pain from Baseline as measured by a 10 cm Visual Analog Scale (VAS).
UNKNOWN
NA
430 participants
3 months
2021-08-10
Participant Flow
Participants underwent screening prior to randomization to verify satisfaction of all inclusion/exclusion criteria. Medical records for enrolled participants were evaluated by independent medical monitors for oversight of appropriate patient selection.
Participant milestones
| Measure |
HF10 Therapy Plus CMM
The addition of HF10 (10kHz SCS) therapy to Conventional Medical Management
Senza HF10 Therapy: Senza 10kHz Spinal Cord Stimulation
|
CMM Alone
Conventional Medical Management
CMM: Conventional Medical Management
|
|---|---|---|
|
Overall Study
STARTED
|
113
|
103
|
|
Overall Study
Month-1
|
95
|
101
|
|
Overall Study
Month-3
|
93
|
98
|
|
Overall Study
COMPLETED
|
93
|
98
|
|
Overall Study
NOT COMPLETED
|
20
|
5
|
Reasons for withdrawal
| Measure |
HF10 Therapy Plus CMM
The addition of HF10 (10kHz SCS) therapy to Conventional Medical Management
Senza HF10 Therapy: Senza 10kHz Spinal Cord Stimulation
|
CMM Alone
Conventional Medical Management
CMM: Conventional Medical Management
|
|---|---|---|
|
Overall Study
Lost to Follow-up
|
5
|
3
|
|
Overall Study
Withdrawal by Subject
|
10
|
0
|
|
Overall Study
Adverse Event
|
5
|
2
|
Baseline Characteristics
Comparison of 10 kHz SCS Combined With CMM to CMM Alone in the Treatment of Neuropathic Limb Pain
Baseline characteristics by cohort
| Measure |
HF10 Therapy Plus CMM
n=113 Participants
The addition of HF10 (10kHz SCS) therapy to Conventional Medical Management
Senza HF10 Therapy: Senza 10kHz Spinal Cord Stimulation
|
CMM Alone
n=103 Participants
Conventional Medical Management
CMM: Conventional Medical Management
|
Total
n=216 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
60.7 years
STANDARD_DEVIATION 11.4 • n=5 Participants
|
60.8 years
STANDARD_DEVIATION 9.9 • n=7 Participants
|
60.8 years
STANDARD_DEVIATION 10.7 • n=5 Participants
|
|
Sex: Female, Male
Female
|
43 Participants
n=5 Participants
|
37 Participants
n=7 Participants
|
80 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
70 Participants
n=5 Participants
|
66 Participants
n=7 Participants
|
136 Participants
n=5 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
2 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Asian
|
1 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
3 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
4 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Black or African American
|
18 Participants
n=5 Participants
|
13 Participants
n=7 Participants
|
31 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
87 Participants
n=5 Participants
|
85 Participants
n=7 Participants
|
172 Participants
n=5 Participants
|
|
Race (NIH/OMB)
More than one race
|
2 Participants
n=5 Participants
|
3 Participants
n=7 Participants
|
5 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Lower limb pain visual analog scale (VAS) score
|
7.5 cm
STANDARD_DEVIATION 1.6 • n=5 Participants
|
7.1 cm
STANDARD_DEVIATION 1.6 • n=7 Participants
|
7.3 cm
STANDARD_DEVIATION 1.6 • n=5 Participants
|
PRIMARY outcome
Timeframe: 3 monthsPopulation: Intention-to-treat population including all randomized patients whose status could be determined at the 3-month primary assessment, including patients who failed trial SCS and those who withdrew due to an adverse event at any point after the trial SCS phase in the active treatment arm.
Difference between treatment groups in responder rates in subjects without a clinically meaningful neurological deficit compared with baseline. Responder is defined as a subject who has at least 50% reduction in lower limb pain from Baseline as measured by a 10 cm Visual Analog Scale (VAS).
Outcome measures
| Measure |
HF10 Therapy Plus CMM
n=95 Participants
The addition of HF10 (10kHz SCS) therapy to Conventional Medical Management
Senza HF10 Therapy: Senza 10kHz Spinal Cord Stimulation
|
CMM Alone
n=94 Participants
Conventional Medical Management
CMM: Conventional Medical Management
|
|---|---|---|
|
Composite of Safety and Effectiveness
|
75 Participants
|
5 Participants
|
SECONDARY outcome
Timeframe: 3 monthsDifference between the treatment groups in proportion of subjects with a lower limb pain VAS score ≤ 3 cm.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: 6 monthsDifference between the treatment groups in crossover rates. Subjects who meet pre-specified criteria may elect to crossover to the other treatment arm at 6-month follow-up.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: 6 monthsDifference between the treatment groups in responder rates. Responder is defined as a subject who has at least 50% reduction in lower limb pain from Baseline as measured by a 10 cm Visual Analog Scale (VAS).
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: 6 monthsDifference between the treatment groups in the proportion of remitters (remission is defined as having a lower limb pain VAS score of ≤ 3.0 cm for at least 6 months).
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: 3 monthsDifference between the treatment groups in the proportion of subjects with overall improvement from baseline in neurological assessment (motor, sensory, reflex).
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: 6 monthsDifference between the treatment groups in the proportion of subjects with overall improvement from baseline in neurological assessment (motor, sensory, reflex).
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: 6 monthsDifference between the treatment groups in changes in health-related quality of life as assessed by the EuroQol Five Dimensions questionnaire (EQ-5D-5L).
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: 6 monthsDifference between the treatment groups in the average percentage change from baseline in HbA1c levels.
Outcome measures
Outcome data not reported
Adverse Events
HF10 Therapy Plus CMM
CMM Alone
Serious adverse events
| Measure |
HF10 Therapy Plus CMM
n=113 participants at risk
The addition of HF10 (10kHz SCS) therapy to Conventional Medical Management
Senza HF10 Therapy: Senza 10kHz Spinal Cord Stimulation
|
CMM Alone
n=103 participants at risk
Conventional Medical Management
CMM: Conventional Medical Management
|
|---|---|---|
|
Renal and urinary disorders
Acute kidney injury
|
0.00%
0/113 • 3 months
|
0.97%
1/103 • Number of events 1 • 3 months
|
|
Cardiac disorders
Acute myocardial infarction
|
0.88%
1/113 • Number of events 1 • 3 months
|
0.97%
1/103 • Number of events 1 • 3 months
|
|
Gastrointestinal disorders
Diarrhoea
|
0.00%
0/113 • 3 months
|
0.97%
1/103 • Number of events 1 • 3 months
|
|
Infections and infestations
Sepsis
|
0.88%
1/113 • Number of events 1 • 3 months
|
0.97%
1/103 • Number of events 1 • 3 months
|
|
Infections and infestations
Localised infection
|
0.88%
1/113 • Number of events 1 • 3 months
|
0.00%
0/103 • 3 months
|
|
Injury, poisoning and procedural complications
Extradural haematoma
|
0.88%
1/113 • Number of events 1 • 3 months
|
0.00%
0/103 • 3 months
|
|
Nervous system disorders
Paraplegia
|
0.88%
1/113 • Number of events 1 • 3 months
|
0.00%
0/103 • 3 months
|
|
Nervous system disorders
Headache
|
0.00%
0/113 • 3 months
|
0.97%
1/103 • Number of events 1 • 3 months
|
|
Gastrointestinal disorders
Nausea
|
0.00%
0/113 • 3 months
|
0.97%
1/103 • Number of events 1 • 3 months
|
|
Vascular disorders
Hypotension
|
0.88%
1/113 • Number of events 1 • 3 months
|
0.00%
0/103 • 3 months
|
|
Cardiac disorders
Coronary artery disease
|
0.88%
1/113 • Number of events 1 • 3 months
|
0.00%
0/103 • 3 months
|
|
Vascular disorders
Orthostatic hypotension
|
0.88%
1/113 • Number of events 1 • 3 months
|
0.00%
0/103 • 3 months
|
|
Infections and infestations
Wound infection staphylococcal
|
0.00%
0/113 • 3 months
|
0.97%
1/103 • Number of events 1 • 3 months
|
|
Nervous system disorders
Embolic stroke
|
0.00%
0/113 • 3 months
|
0.97%
1/103 • Number of events 1 • 3 months
|
|
Nervous system disorders
Encephalopathy
|
0.00%
0/113 • 3 months
|
0.97%
1/103 • Number of events 1 • 3 months
|
|
Vascular disorders
Hypertensive emergency
|
0.00%
0/113 • 3 months
|
0.97%
1/103 • Number of events 1 • 3 months
|
|
Injury, poisoning and procedural complications
Cervical vertebral fracture
|
0.00%
0/113 • 3 months
|
0.97%
1/103 • Number of events 1 • 3 months
|
|
Infections and infestations
Pneumonia
|
0.88%
1/113 • Number of events 1 • 3 months
|
0.97%
1/103 • Number of events 1 • 3 months
|
|
Infections and infestations
Septic shock
|
0.00%
0/113 • 3 months
|
0.97%
1/103 • Number of events 1 • 3 months
|
|
Infections and infestations
Staphylococcal infection
|
0.00%
0/113 • 3 months
|
0.97%
1/103 • Number of events 1 • 3 months
|
|
Respiratory, thoracic and mediastinal disorders
Acute respiratory failure
|
0.88%
1/113 • Number of events 1 • 3 months
|
0.00%
0/103 • 3 months
|
|
General disorders
Chest pain
|
0.88%
1/113 • Number of events 1 • 3 months
|
0.00%
0/103 • 3 months
|
|
General disorders
Pyrexia
|
0.88%
1/113 • Number of events 1 • 3 months
|
0.00%
0/103 • 3 months
|
|
Hepatobiliary disorders
Cholangitis acute
|
0.88%
1/113 • Number of events 1 • 3 months
|
0.00%
0/103 • 3 months
|
|
Gastrointestinal disorders
Pancreatic mass
|
0.88%
1/113 • Number of events 1 • 3 months
|
0.00%
0/103 • 3 months
|
|
Gastrointestinal disorders
Pancreatitis chronic
|
0.88%
1/113 • Number of events 1 • 3 months
|
0.00%
0/103 • 3 months
|
|
Gastrointestinal disorders
Pancreatic disorder
|
0.00%
0/113 • 3 months
|
0.97%
1/103 • Number of events 1 • 3 months
|
|
Musculoskeletal and connective tissue disorders
Osteoarthritis
|
0.88%
1/113 • Number of events 1 • 3 months
|
0.00%
0/103 • 3 months
|
|
Cardiac disorders
Cardiac arrest
|
0.88%
1/113 • Number of events 1 • 3 months
|
0.00%
0/103 • 3 months
|
|
Infections and infestations
Wound infection
|
0.88%
1/113 • Number of events 1 • 3 months
|
0.00%
0/103 • 3 months
|
|
Infections and infestations
Endocarditis
|
0.00%
0/113 • 3 months
|
0.97%
1/103 • Number of events 1 • 3 months
|
|
Cardiac disorders
Myocardial infarction
|
0.00%
0/113 • 3 months
|
0.97%
1/103 • Number of events 1 • 3 months
|
Other adverse events
Adverse event data not reported
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee Initial publication of the results will be a joint, multicenter publication with all PIs and sites contributing data, analyses, and critical review of the manuscript. If no such publication occurs within 12 months of study completion, individual PIs may publish results from their center. PIs will allow sponsor 30 days to review any potential publications or presentations and sponsor can request an additional 60 days if needed.
- Publication restrictions are in place
Restriction type: OTHER