Chronic Pain
Conditions
Keywords
SCS, Burst stimulation
Brief summary
The purpose of this study is to confirm long term efficacy and safety of the ProdigyTM neuromodulation system in the management of failed back surgery syndrome or chronic intractable pain of the trunk and/or limbs.
Interventions
PROCEDUREBurst and Tonic stimulation
Sponsors
Abbott Medical Devices
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Patient with chronic, intractable pain of the trunk and/or limbs, including unilateral or bilateral pain associated with the following: failed back surgery syndrome or intractable low back and/or leg pain * Patient diagnosed with radiculopathy * Patient diagnosed with neuropathic pain * Patient is considered by the investigator as a candidate for implantation of a SCS system * Patient is ≥ 18 years of age * Patient must be willing and able to comply with study requirements * Patient must indicate his/her understanding of the study and willingness to participate by signing an appropriate Informed Consent Form
Exclusion criteria
* Patient is diagnosed with ischemic pain * Patient is diagnosed with arachnoiditis * Patient is diagnosed with complex regional pain syndrome (CRPS I and II) * Patient is diagnosed with peripheral vascular disease (PVD) * Patient is diagnosed with diabetic neuropathic pain * Patient is diagnosed with chronic migraine * Patient is immune-compromised * Patient has history of cancer requiring active treatment in the last 6 months * Patient has a documented history of substance abuse (narcotics, alcohol, etc.) or substance dependency in the last 6 months * Patients with a SCS system or implantable infusion pump implanted previously * Patient has a life expectancy of less than one year * Patient is pregnant or is planning to become pregnant during the duration of the investigation * Patient is unable to comply with the follow up schedule * Patient needing legally authorized representative * Patient unable to read and write * Patient is currently participating in another clinical investigation with an active treatment arm.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Percentage Change From Baseline in Overall VAS at 3 Months | 3 months | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Change in Pain Catastrophizing Scale | 12 Months | 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. |
| Number of Participants With Analgesic Reduction | 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. |
| Pain Relief | 3 Months | Patient 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. |
| Rate of Serious Adverse Events and/or Procedure/Device-related Adverse Events | from enrollment to 12 months follow up | 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. |
| Paresthesia Mapping at 3 Months Compared to the Empower Study | 3 Months | 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). |
| Change in Quality of Life | Baseline and 12 Months | 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). |
Countries
Australia, Belgium, Germany, Ireland, Italy, Netherlands, Spain, Sweden, United Kingdom
Participant flow
Pre-assignment details
A total of 126 subjects were enrolled, 1 discontinued the study prior to the baseline visit.
Participants by arm
| Arm | Count |
|---|---|
| Observational Cohort All enrolled patients. | 125 |
| Total | 125 |
Withdrawals & dropouts
| Period | Reason | FG000 |
|---|---|---|
| Any Program (6-12 Months) | Withdrawal by Subject | 2 |
| Any Programming (3-6 Months) | Missing Data | 1 |
| Any Programming (3-6 Months) | Withdrawal by Subject | 3 |
| Burst Stimulation Only (3 Months) | Missing Data | 4 |
| Burst Stimulation Only (3 Months) | Withdrawal by Subject | 4 |
| Enrolled | Withdrawal by Subject | 4 |
| Trial Stimulation | Lack of Efficacy | 21 |
Baseline characteristics
| Characteristic | Observational Cohort | — |
|---|---|---|
| Age, Continuous | 55 years STANDARD_DEVIATION 14 | — |
| Did Subject's Pain Cause Subject to Stop Working No | 25 Participants | — |
| Did Subject's Pain Cause Subject to Stop Working Not applicable | 7 Participants | — |
| Did Subject's Pain Cause Subject to Stop Working Yes | 58 Participants | — |
| Primary Diagnosis Failed Back Surgery Syndrome (FBSS) | 98 Participants | — |
| Primary Diagnosis Other Pain Conditions | 14 Participants | — |
| Primary Diagnosis Radiculopathy | 13 Participants | — |
| Race and Ethnicity Not Collected | — | — Participants |
| Region of Enrollment Australia | 13 participants | — |
| Region of Enrollment Belgium | 8 participants | — |
| Region of Enrollment Germany | 47 participants | — |
| Region of Enrollment Italy | 20 participants | — |
| Region of Enrollment Netherlands | 10 participants | — |
| Region of Enrollment Spain | 3 participants | — |
| Region of Enrollment Sweden | 4 participants | — |
| Region of Enrollment United Kingdom | 20 participants | — |
| Sex: Female, Male Female | 70 Participants | — |
| Sex: Female, Male Male | 55 Participants | — |
| Work Status Full-time | 17 Participants | — |
| Work Status Not Working | 90 Participants | — |
| Work Status Part-time | 18 Participants | — |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | 0 / 126 |
| other Total, other adverse events | 31 / 126 |
| serious Total, serious adverse events | 39 / 126 |
Outcome results
Primary
Percentage Change From Baseline in Overall VAS at 3 Months
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.
Time frame: 3 months
Population: 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.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Burst Patients With Available Data | Percentage Change From Baseline in Overall VAS at 3 Months | -51.3 Percentage change | Standard Deviation 36.1 |
Secondary
Change in Pain Catastrophizing Scale
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.
Time frame: 12 Months
Population: 84 patients had available data at baseline and 12 months for pain catastrophizing
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Burst Patients With Available Data | Change in Pain Catastrophizing Scale | -13 score on a scale | Standard Deviation 15 |
Secondary
Change in Quality of Life
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).
Time frame: Baseline and 12 Months
Population: 125 subjects had available data for the EQ-5D questionnaire at baseline and 85 at the 12 Months follow-up visit.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Burst Patients With Available Data | Change in Quality of Life | Baseline | 46 units on a scale | Standard Deviation 22 |
| Burst Patients With Available Data | Change in Quality of Life | 12 Months | 62 units on a scale | Standard Deviation 23 |
Secondary
Number of Participants With Analgesic Reduction
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.
Time frame: 12 Months
Population: 19 patients had data available for analgesic usage at baseline and 12 Months.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Burst Patients With Available Data | Number of Participants With Analgesic Reduction | 3 Participants |
Secondary
Pain Relief
Patient 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.
Time frame: 3 Months
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Burst Patients With Available Data | Pain Relief | 53.9 percentage of pain relief | Standard Deviation 28.5 |
Secondary
Pain Relief
Patient 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.
Time frame: 6 Months
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Burst Patients With Available Data | Pain Relief | 56.4 percentage of pain relief | Standard Deviation 28.8 |
Secondary
Pain Relief
Patient 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.
Time frame: 12 Months
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Burst Patients With Available Data | Pain Relief | 55.5 percentage of pain relief | Standard Deviation 31.2 |
Secondary
Paresthesia Mapping at 3 Months Compared to the Empower Study
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).
Time frame: 3 Months
Population: 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
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Burst Patients With Available Data | Paresthesia Mapping at 3 Months Compared to the Empower Study | 18.2 percentage of paresthesias | Standard Deviation 10.6 |
Secondary
Rate of Serious Adverse Events and/or Procedure/Device-related Adverse Events
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.
Time frame: from enrollment to 12 months follow up
Population: All enrolled subjects who were at risk for SAE's and ADE's
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Burst Patients With Available Data | Rate of Serious Adverse Events and/or Procedure/Device-related Adverse Events | Serious Adverse Events | 57 events |
| Burst Patients With Available Data | Rate of Serious Adverse Events and/or Procedure/Device-related Adverse Events | Adverse Device Effects | 24 events |