Trial Outcomes & Findings for Evaluate St Jude Medical Prodigy Neuromodulation for FBSS or Chronic Pain of the Trunk and/or Limbs (NCT NCT02143791)
NCT ID: NCT02143791
Last Updated: 2024-07-08
Results Overview
Percentage change in pain relief at the 3- month follow-up visit compared to baseline visit, as measured by the Visual Analog Scale (VAS). The VAS scale with a 10 cm (or 100 mm) line to indicate pain intensity progression with no pain (0) on the left end and worst pain (100) on the right end. Percent change is calculated as "\[(post baseline baseline)/baseline\] \*100%" with positive numbers to represent increases and negative numbers to represent decreases.
COMPLETED
NA
126 participants
3 months
2024-07-08
Participant Flow
A total of 126 subjects were enrolled, 1 discontinued the study prior to the baseline visit.
Participant milestones
| Measure |
Observational Cohort
All enrolled patients.
|
|---|---|
|
Enrolled
STARTED
|
125
|
|
Enrolled
COMPLETED
|
121
|
|
Enrolled
NOT COMPLETED
|
4
|
|
Trial Stimulation
STARTED
|
121
|
|
Trial Stimulation
COMPLETED
|
100
|
|
Trial Stimulation
NOT COMPLETED
|
21
|
|
Burst Stimulation Only (3 Months)
STARTED
|
100
|
|
Burst Stimulation Only (3 Months)
COMPLETED
|
92
|
|
Burst Stimulation Only (3 Months)
NOT COMPLETED
|
8
|
|
Any Programming (3-6 Months)
STARTED
|
92
|
|
Any Programming (3-6 Months)
COMPLETED
|
88
|
|
Any Programming (3-6 Months)
NOT COMPLETED
|
4
|
|
Any Program (6-12 Months)
STARTED
|
88
|
|
Any Program (6-12 Months)
COMPLETED
|
86
|
|
Any Program (6-12 Months)
NOT COMPLETED
|
2
|
Reasons for withdrawal
| Measure |
Observational Cohort
All enrolled patients.
|
|---|---|
|
Enrolled
Withdrawal by Subject
|
4
|
|
Trial Stimulation
Lack of Efficacy
|
21
|
|
Burst Stimulation Only (3 Months)
Withdrawal by Subject
|
4
|
|
Burst Stimulation Only (3 Months)
Missing Data
|
4
|
|
Any Programming (3-6 Months)
Withdrawal by Subject
|
3
|
|
Any Programming (3-6 Months)
Missing Data
|
1
|
|
Any Program (6-12 Months)
Withdrawal by Subject
|
2
|
Baseline Characteristics
Race and Ethnicity were not collected from any participant.
Baseline characteristics by cohort
| Measure |
Observational Cohort
n=125 Participants
All enrolled patients.
|
|---|---|
|
Age, Continuous
|
55 years
STANDARD_DEVIATION 14 • n=125 Participants
|
|
Sex: Female, Male
Female
|
70 Participants
n=125 Participants
|
|
Sex: Female, Male
Male
|
55 Participants
n=125 Participants
|
|
Region of Enrollment
Germany
|
47 participants
n=125 Participants
|
|
Region of Enrollment
Italy
|
20 participants
n=125 Participants
|
|
Region of Enrollment
United Kingdom
|
20 participants
n=125 Participants
|
|
Region of Enrollment
Belgium
|
8 participants
n=125 Participants
|
|
Region of Enrollment
Australia
|
13 participants
n=125 Participants
|
|
Region of Enrollment
Netherlands
|
10 participants
n=125 Participants
|
|
Region of Enrollment
Sweden
|
4 participants
n=125 Participants
|
|
Region of Enrollment
Spain
|
3 participants
n=125 Participants
|
|
Primary Diagnosis
Radiculopathy
|
13 Participants
n=125 Participants
|
|
Primary Diagnosis
Failed Back Surgery Syndrome (FBSS)
|
98 Participants
n=125 Participants
|
|
Primary Diagnosis
Other Pain Conditions
|
14 Participants
n=125 Participants
|
|
Work Status
Full-time
|
17 Participants
n=125 Participants
|
|
Work Status
Part-time
|
18 Participants
n=125 Participants
|
|
Work Status
Not Working
|
90 Participants
n=125 Participants
|
|
Did Subject's Pain Cause Subject to Stop Working
Yes
|
58 Participants
n=90 Participants • Only subjects who reported "Not Working" when asked about work status (N=90) answered this question.
|
|
Did Subject's Pain Cause Subject to Stop Working
No
|
25 Participants
n=90 Participants • Only subjects who reported "Not Working" when asked about work status (N=90) answered this question.
|
|
Did Subject's Pain Cause Subject to Stop Working
Not applicable
|
7 Participants
n=90 Participants • Only subjects who reported "Not Working" when asked about work status (N=90) answered this question.
|
PRIMARY outcome
Timeframe: 3 monthsPopulation: 92 patients completed 3 months, but 86 patients had Burst programs only and had available data for Baseline and the 3-month follow-up visit.
Percentage change in pain relief at the 3- month follow-up visit compared to baseline visit, as measured by the Visual Analog Scale (VAS). The VAS scale with a 10 cm (or 100 mm) line to indicate pain intensity progression with no pain (0) on the left end and worst pain (100) on the right end. Percent change is calculated as "\[(post baseline baseline)/baseline\] \*100%" with positive numbers to represent increases and negative numbers to represent decreases.
Outcome measures
| Measure |
Burst Patients With Available Data
n=86 Participants
Subjects reporting percentage of Pain relief as mentioned with VAS in the Prodigy I study.
|
|---|---|
|
Percentage Change From Baseline in Overall VAS at 3 Months
|
-51.3 Percentage change
Standard Deviation 36.1
|
SECONDARY outcome
Timeframe: 3 MonthsPatient reported pain relief. Patients were asked to evaluate their pain relief over the past week in percentage with 0% being no pain relief and 100% being complete pain relief.
Outcome measures
| Measure |
Burst Patients With Available Data
n=90 Participants
Subjects reporting percentage of Pain relief as mentioned with VAS in the Prodigy I study.
|
|---|---|
|
Pain Relief
|
53.9 percentage of pain relief
Standard Deviation 28.5
|
SECONDARY outcome
Timeframe: 6 MonthsPatient reported pain relief. Patients were asked to evaluate their pain relief over the past week in percentage with 0% being no pain relief and 100% being complete pain relief.
Outcome measures
| Measure |
Burst Patients With Available Data
n=84 Participants
Subjects reporting percentage of Pain relief as mentioned with VAS in the Prodigy I study.
|
|---|---|
|
Pain Relief
|
56.4 percentage of pain relief
Standard Deviation 28.8
|
SECONDARY outcome
Timeframe: 12 MonthsPatient reported pain relief. Patients were asked to evaluate their pain relief over the past week in percentage with 0% being no pain and 100% being complete pain relief.
Outcome measures
| Measure |
Burst Patients With Available Data
n=86 Participants
Subjects reporting percentage of Pain relief as mentioned with VAS in the Prodigy I study.
|
|---|---|
|
Pain Relief
|
55.5 percentage of pain relief
Standard Deviation 31.2
|
SECONDARY outcome
Timeframe: 12 MonthsPopulation: 84 patients had available data at baseline and 12 months for pain catastrophizing
The pain catastrophizing scale (PCS) is a validated scale containing 13 items to assess thoughts and feelings about pain while a person is experiencing pain. The total of all 13 items results in a minimum of 0 and a maximum of 54; scores above 30 indicate clinically significant pain catastrophizing. The mean change was calculated based on the value at 12 months minus the value at baseline.
Outcome measures
| Measure |
Burst Patients With Available Data
n=84 Participants
Subjects reporting percentage of Pain relief as mentioned with VAS in the Prodigy I study.
|
|---|---|
|
Change in Pain Catastrophizing Scale
|
-13 score on a scale
Standard Deviation 15
|
SECONDARY outcome
Timeframe: 12 MonthsPopulation: 19 patients had data available for analgesic usage at baseline and 12 Months.
Patient reported analgesic usage during the 4 weeks preceding the 12-month follow-up visit, compared to the baseline visit. The amount of patients who decreased the dose are reported.
Outcome measures
| Measure |
Burst Patients With Available Data
n=19 Participants
Subjects reporting percentage of Pain relief as mentioned with VAS in the Prodigy I study.
|
|---|---|
|
Number of Participants With Analgesic Reduction
|
3 Participants
|
SECONDARY outcome
Timeframe: Baseline and 12 MonthsPopulation: 125 subjects had available data for the EQ-5D questionnaire at baseline and 85 at the 12 Months follow-up visit.
Subjects were provided with the Euroqol-5 dimensions (EQ-5D) questionnaire at baseline and 12 Months follow-up visit. In that questionnaire, subjects were asked to indicate a score for their health on a scale where 100 would mean 'the best state he/she can imagine' and 0 would be the 'worst state he/she can imagine).
Outcome measures
| Measure |
Burst Patients With Available Data
n=125 Participants
Subjects reporting percentage of Pain relief as mentioned with VAS in the Prodigy I study.
|
|---|---|
|
Change in Quality of Life
Baseline
|
46 units on a scale
Standard Deviation 22
|
|
Change in Quality of Life
12 Months
|
62 units on a scale
Standard Deviation 23
|
SECONDARY outcome
Timeframe: from enrollment to 12 months follow upPopulation: All enrolled subjects who were at risk for SAE's and ADE's
Adverse device effects were defined as adverse events related to the study procedures or the device. Serious events were those that resulted in-patient or prolonged hospitalization or were life-threatening.
Outcome measures
| Measure |
Burst Patients With Available Data
n=125 Participants
Subjects reporting percentage of Pain relief as mentioned with VAS in the Prodigy I study.
|
|---|---|
|
Rate of Serious Adverse Events and/or Procedure/Device-related Adverse Events
Serious Adverse Events
|
57 events
|
|
Rate of Serious Adverse Events and/or Procedure/Device-related Adverse Events
Adverse Device Effects
|
24 events
|
SECONDARY outcome
Timeframe: 3 MonthsPopulation: 92 patients completed 3 months, but 87 patients had Burst programs only and had available data for Baseline and the 3-month follow-up visit
Paresthesia mapping is expressed in percent of paresthesia areas as indicated by the patient on a gender specific body diagram. 87 subjects with Burst stimulation at 3 Months (Prodigy-I) were compared to 134 subjects with tonic stimulation at 3 Months (Empower).
Outcome measures
| Measure |
Burst Patients With Available Data
n=87 Participants
Subjects reporting percentage of Pain relief as mentioned with VAS in the Prodigy I study.
|
|---|---|
|
Paresthesia Mapping at 3 Months Compared to the Empower Study
|
18.2 percentage of paresthesias
Standard Deviation 10.6
|
Adverse Events
Observational Cohort
Serious adverse events
| Measure |
Observational Cohort
n=126 participants at risk
All enrolled patients.
|
|---|---|
|
Cardiac disorders
Coronary artery disease
|
0.79%
1/126 • Number of events 1 • 1 year
|
|
Cardiac disorders
acute cardiac decompensation
|
0.79%
1/126 • Number of events 1 • 1 year
|
|
Cardiac disorders
cardiac catherization
|
0.79%
1/126 • Number of events 1 • 1 year
|
|
Endocrine disorders
hypothyriodism
|
0.79%
1/126 • Number of events 1 • 1 year
|
|
Gastrointestinal disorders
Diverticulosis
|
0.79%
1/126 • Number of events 1 • 1 year
|
|
Gastrointestinal disorders
upper abdominal pain
|
0.79%
1/126 • Number of events 1 • 1 year
|
|
General disorders
Lead Breakage/Fracture
|
0.79%
1/126 • Number of events 1 • 1 year
|
|
General disorders
Lead contacts mostly invalid
|
0.79%
1/126 • Number of events 1 • 1 year
|
|
General disorders
Lead migration
|
1.6%
2/126 • Number of events 2 • 1 year
|
|
General disorders
Pain medication intolerance
|
0.79%
1/126 • Number of events 1 • 1 year
|
|
General disorders
Persistant pain and/or numbness IPG site only
|
0.79%
1/126 • Number of events 1 • 1 year
|
|
General disorders
Undesirable changes in paresthesia
|
0.79%
1/126 • Number of events 1 • 1 year
|
|
General disorders
device uncomfortable
|
0.79%
1/126 • Number of events 1 • 1 year
|
|
General disorders
opiate withdrawal
|
0.79%
1/126 • Number of events 1 • 1 year
|
|
Infections and infestations
Ear infection
|
0.79%
1/126 • Number of events 1 • 1 year
|
|
Infections and infestations
Infection: IPG & Lead site
|
1.6%
2/126 • Number of events 2 • 1 year
|
|
Infections and infestations
Infection: IPG site only
|
0.79%
1/126 • Number of events 1 • 1 year
|
|
Infections and infestations
Infection: Lead site only
|
0.79%
1/126 • Number of events 1 • 1 year
|
|
Infections and infestations
Infection: extension site only
|
0.79%
1/126 • Number of events 1 • 1 year
|
|
Injury, poisoning and procedural complications
CSF leakage
|
0.79%
1/126 • Number of events 1 • 1 year
|
|
Investigations
malignant tumor
|
0.79%
1/126 • Number of events 1 • 1 year
|
|
Musculoskeletal and connective tissue disorders
Fall
|
0.79%
1/126 • Number of events 1 • 1 year
|
|
Musculoskeletal and connective tissue disorders
ISG arthrose
|
0.79%
1/126 • Number of events 1 • 1 year
|
|
Musculoskeletal and connective tissue disorders
Osteoarthritis
|
0.79%
1/126 • Number of events 1 • 1 year
|
|
Musculoskeletal and connective tissue disorders
Pain in hip
|
0.79%
1/126 • Number of events 2 • 1 year
|
|
Musculoskeletal and connective tissue disorders
Persistant pain and/or numbness: undetermined
|
0.79%
1/126 • Number of events 1 • 1 year
|
|
Musculoskeletal and connective tissue disorders
iliosacral joint osteoarthritis
|
0.79%
1/126 • Number of events 1 • 1 year
|
|
Musculoskeletal and connective tissue disorders
pain in leg
|
0.79%
1/126 • Number of events 2 • 1 year
|
|
Musculoskeletal and connective tissue disorders
pain in vertrebral region due to fall
|
0.79%
1/126 • Number of events 1 • 1 year
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Bladder cancer diagnosed
|
0.79%
1/126 • Number of events 1 • 1 year
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
malignant tumor
|
0.79%
1/126 • Number of events 1 • 1 year
|
|
Nervous system disorders
ataxic gait disturbance
|
0.79%
1/126 • Number of events 1 • 1 year
|
|
Product Issues
IPG migration
|
0.79%
1/126 • Number of events 1 • 1 year
|
|
Product Issues
Lead breakage/fracture
|
1.6%
2/126 • Number of events 2 • 1 year
|
|
Product Issues
Lead migration
|
2.4%
3/126 • Number of events 3 • 1 year
|
|
Product Issues
Persistant pain and/or numbness: Lead site only
|
0.79%
1/126 • Number of events 1 • 1 year
|
|
Product Issues
Undesirable changes in pain
|
1.6%
2/126 • Number of events 2 • 1 year
|
|
Product Issues
bad connection IPG-extension
|
0.79%
1/126 • Number of events 1 • 1 year
|
|
Product Issues
bad connection between lead and IPG
|
0.79%
1/126 • Number of events 1 • 1 year
|
|
Product Issues
insufficient paresthesia coverage
|
0.79%
1/126 • Number of events 1 • 1 year
|
|
Psychiatric disorders
Anxiety disorder
|
0.79%
1/126 • Number of events 1 • 1 year
|
|
Renal and urinary disorders
Inability to control urination
|
0.79%
1/126 • Number of events 1 • 1 year
|
|
Reproductive system and breast disorders
ovarian abcess
|
0.79%
1/126 • Number of events 1 • 1 year
|
|
Skin and subcutaneous tissue disorders
Pain at IPG pocket
|
0.79%
1/126 • Number of events 1 • 1 year
|
|
Vascular disorders
microcirculation disturbance right foot
|
0.79%
1/126 • Number of events 1 • 1 year
|
|
Vascular disorders
peripheral artery disease
|
0.79%
1/126 • Number of events 1 • 1 year
|
|
Vascular disorders
varicose vein surgery
|
0.79%
1/126 • Number of events 1 • 1 year
|
|
Vascular disorders
varicose veins
|
0.79%
1/126 • Number of events 1 • 1 year
|
Other adverse events
| Measure |
Observational Cohort
n=126 participants at risk
All enrolled patients.
|
|---|---|
|
Gastrointestinal disorders
Diarrhea and vomitting
|
0.79%
1/126 • Number of events 1 • 1 year
|
|
Gastrointestinal disorders
Gastroenteritis
|
0.79%
1/126 • Number of events 1 • 1 year
|
|
General disorders
Undesirable changes in pain
|
0.79%
1/126 • Number of events 1 • 1 year
|
|
General disorders
Opiate withdrawal
|
0.79%
1/126 • Number of events 1 • 1 year
|
|
General disorders
Undesirable changes in paraesthesia
|
2.4%
3/126 • Number of events 3 • 1 year
|
|
Infections and infestations
Dental abcess
|
0.79%
1/126 • Number of events 1 • 1 year
|
|
Infections and infestations
Infection: IPG site only
|
0.79%
1/126 • Number of events 1 • 1 year
|
|
Infections and infestations
Infection: Lead site only
|
0.79%
1/126 • Number of events 1 • 1 year
|
|
Infections and infestations
Respiratory infection
|
2.4%
3/126 • Number of events 3 • 1 year
|
|
Infections and infestations
Urinary tract infection
|
0.79%
1/126 • Number of events 1 • 1 year
|
|
Musculoskeletal and connective tissue disorders
Fall
|
2.4%
3/126 • Number of events 4 • 1 year
|
|
Musculoskeletal and connective tissue disorders
Joint pain
|
0.79%
1/126 • Number of events 1 • 1 year
|
|
Musculoskeletal and connective tissue disorders
Knee effusion
|
0.79%
1/126 • Number of events 1 • 1 year
|
|
Musculoskeletal and connective tissue disorders
Muscle pain
|
0.79%
1/126 • Number of events 1 • 1 year
|
|
Musculoskeletal and connective tissue disorders
Unintended stimulation effects: muscle spasms or cramping
|
2.4%
3/126 • Number of events 3 • 1 year
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Related to bladder carcinoma
|
0.79%
1/126 • Number of events 1 • 1 year
|
|
Nervous system disorders
Headaches- post procedure
|
0.79%
1/126 • Number of events 1 • 1 year
|
|
Product Issues
High impedance
|
0.79%
1/126 • Number of events 1 • 1 year
|
|
Product Issues
Lead breakage/fracture
|
1.6%
2/126 • Number of events 2 • 1 year
|
|
Product Issues
Lead extension retraction
|
0.79%
1/126 • Number of events 1 • 1 year
|
|
Product Issues
Lead migration
|
0.79%
1/126 • Number of events 1 • 1 year
|
|
Product Issues
Persistent pain and/or numbness: undetermined
|
0.79%
1/126 • Number of events 1 • 1 year
|
|
Product Issues
Undesirable changes in pain
|
1.6%
2/126 • Number of events 2 • 1 year
|
|
Product Issues
Undesirable changes in paraesthesia
|
1.6%
2/126 • Number of events 2 • 1 year
|
|
Product Issues
Undesirable changes in stimulation
|
1.6%
2/126 • Number of events 2 • 1 year
|
|
Skin and subcutaneous tissue disorders
Burning sensation at IPG site
|
0.79%
1/126 • Number of events 1 • 1 year
|
|
Skin and subcutaneous tissue disorders
Subcutaneous tissue changes at implant site
|
0.79%
1/126 • Number of events 1 • 1 year
|
|
Skin and subcutaneous tissue disorders
Wound site complication
|
0.79%
1/126 • Number of events 1 • 1 year
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place