Trial Outcomes & Findings for Multi-center Prospective Study Determining the Sustainability of Pain Relief and Psychosocial and Functional Responses When Utilizing a Multiple Waveform Enabled Neurostimulator (NCT NCT03082261)

Results Overview

The pain NRS consists of 1 question that will be asked by interviewing the subjects. Patients will be asked to rate, from 0 (no pain) to 10 (worst imaginable pain), their average pain over the past 24 hours specific to the area(s) of chronic pain being treated. A higher score indicates greater pain intensity.

Recruitment status

COMPLETED

Study phase

NA

Target enrollment

269 participants

Primary outcome timeframe

Baseline to 6 Months

Results posted on

2021-07-08

Participant Flow

A total of 269 subjects were enrolled at 22 investigational sites. The enrollment of the first subject was on 03 March 2017 and the last subject was on 13 February 2018. The last follow-up visit occurred on 26 August 2020.

Participant milestones

Participant milestones
Measure	All Enrolled Subjects All subjects enrolled into the study with intent to treat with either a Prodigy, Prodigy MRI, or Proclaim Elite Implantable Pulse Generator (IPG). Prodigy, Prodigy MRI or Proclaim Elite IPG: Subjects will be permanently implanted with either a Prodigy, Prodigy MRI or Proclaim Elite IPG
Overall Study STARTED	269
Overall Study COMPLETED	149
Overall Study NOT COMPLETED	120

Reasons for withdrawal

Reasons for withdrawal
Measure	All Enrolled Subjects All subjects enrolled into the study with intent to treat with either a Prodigy, Prodigy MRI, or Proclaim Elite Implantable Pulse Generator (IPG). Prodigy, Prodigy MRI or Proclaim Elite IPG: Subjects will be permanently implanted with either a Prodigy, Prodigy MRI or Proclaim Elite IPG
Overall Study Death	4
Overall Study Implant of dorsal root ganglion stimulation (DRG) device	1
Overall Study Insurance denial	1
Overall Study Peripheral lead added	1
Overall Study Withdrawal by Subject	40
Overall Study Subject did not meet screening inclusion/exclusion criteria	2
Overall Study Subject implanted with device other than study device	1
Overall Study Lost to Follow-up	14
Overall Study Subject moved to a different state	1
Overall Study Subject non-compliance	2
Overall Study Subject participation terminated by investigator	9
Overall Study Subject participation terminated by sponsor	4
Overall Study System explant	19
Overall Study Unable to place lead(s)	2
Overall Study Unsuccessful trial evaluation period	19

Baseline Characteristics

Race and Ethnicity were not collected from any participant.

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	All Enrolled Subjects n=269 Participants All subjects enrolled into the study with intent to treat with either a Prodigy, Prodigy MRI, or Proclaim Elite IPG. Prodigy, Prodigy MRI or Proclaim Elite IPG: Subjects will be permanently implanted with either a Prodigy, Prodigy MRI or Proclaim Elite IPG
Age, Continuous	59.4 years STANDARD_DEVIATION 13.6 • n=269 Participants
Sex: Female, Male Female	166 Participants n=269 Participants
Sex: Female, Male Male	103 Participants n=269 Participants
Region of Enrollment Canada	7 participants n=269 Participants
Region of Enrollment United States	210 participants n=269 Participants
Region of Enrollment Finland	12 participants n=269 Participants
Region of Enrollment Italy	8 participants n=269 Participants
Region of Enrollment Switzerland	1 participants n=269 Participants
Region of Enrollment Germany	5 participants n=269 Participants
Region of Enrollment Spain	26 participants n=269 Participants
Duration of Experiencing Chronic Pain	9.7 years STANDARD_DEVIATION 8.6 • n=269 Participants

PRIMARY outcome

Timeframe: Baseline to 6 Months

Population: The number of participants analyzed includes subjects who were available at the time of analysis

The pain NRS consists of 1 question that will be asked by interviewing the subjects. Patients will be asked to rate, from 0 (no pain) to 10 (worst imaginable pain), their average pain over the past 24 hours specific to the area(s) of chronic pain being treated. A higher score indicates greater pain intensity.

Outcome measures

Outcome measures
Measure	All Enrolled Subjects n=181 Participants All subjects enrolled into the study with intent to treat with either a Prodigy, Prodigy MRI, or Proclaim Elite IPG. Prodigy, Prodigy MRI or Proclaim Elite IPG: Subjects will be permanently implanted with either a Prodigy, Prodigy MRI or Proclaim Elite IPG
Mean Change in Pain From Baseline to 6 Months Post-permanent Implant, Assessed by the Numeric Rating Scale (NRS) Baseline	7.6 score on a scale Standard Deviation 1.1
Mean Change in Pain From Baseline to 6 Months Post-permanent Implant, Assessed by the Numeric Rating Scale (NRS) 6 months	4.6 score on a scale Standard Deviation 2.4
Mean Change in Pain From Baseline to 6 Months Post-permanent Implant, Assessed by the Numeric Rating Scale (NRS) Change from baseline to 6 months	3.0 score on a scale Standard Deviation 2.6

SECONDARY outcome

Timeframe: Baseline to 6 Months

Population: The number of participants analyzed includes subjects who were available at the time of analysis

EQ5D is a standardized instrument for use as a measure of health outcome applicable to a wide range of health conditions and treatments. It provides a simple descriptive profile and a single index value for health status. The EQ5D-3L descriptive system comprises the following 5 dimensions: mobility, self-care, usual activities, pain/discomfort and anxiety/depression. Each dimension has 3 levels: no problems, some problems, extreme problems. A visual analog scale (VAS) for health is also included in the measure as a patient-reported estimate of overall health status. EQ5D Index scores range from - 0.594 (min) to 1 (max). An EQ-5D summary index is derived by applying a formula that attaches values (weights) to each of the levels in each dimension. Higher values represent better outcomes.

Outcome measures

Outcome measures
Measure	All Enrolled Subjects n=180 Participants All subjects enrolled into the study with intent to treat with either a Prodigy, Prodigy MRI, or Proclaim Elite IPG. Prodigy, Prodigy MRI or Proclaim Elite IPG: Subjects will be permanently implanted with either a Prodigy, Prodigy MRI or Proclaim Elite IPG
Mean Change in Quality of Life From Baseline to 6 Months Post-permanent Implant, Assessed by the EuroQuol-5 Dimensions (EQ5D) Questionnaire Baseline	0.44 score on a scale Standard Deviation 0.22
Mean Change in Quality of Life From Baseline to 6 Months Post-permanent Implant, Assessed by the EuroQuol-5 Dimensions (EQ5D) Questionnaire 6 months	0.65 score on a scale Standard Deviation 0.21
Mean Change in Quality of Life From Baseline to 6 Months Post-permanent Implant, Assessed by the EuroQuol-5 Dimensions (EQ5D) Questionnaire Change from baseline to 6 months	0.21 score on a scale Standard Deviation 0.22

SECONDARY outcome

Timeframe: Baseline to 6 Months

Population: The number of participants analyzed includes subjects who were available at the time of analysis

The PCS is a validated scale that measures the magnitude of catastrophizing (negative thoughts and feelings while a patient is experiencing pain). Subjects answer questions about how they feel and what they think about when they are in pain (i.e., not at the current moment). The scale includes 13 statements concerning pain experiences that are rated on a scale between 0 'not at all' and 4 'always'. The scale is self-administered and takes 5 minutes to complete. A higher score indicated a higher level of catastrophizing. PCS total scores range from 0 (min) to 52 (max). Three sub-scales consists of rumination, magnification, and helplessness. Rumination scores range from 0 (min) to 16 (max), Magnification scores range from 0 (min) to 12 (max), and helplessness scores range from 0 (min) to 24 (max). The total PCS score is the sum of the three subscales.

Outcome measures

Outcome measures
Measure	All Enrolled Subjects n=180 Participants All subjects enrolled into the study with intent to treat with either a Prodigy, Prodigy MRI, or Proclaim Elite IPG. Prodigy, Prodigy MRI or Proclaim Elite IPG: Subjects will be permanently implanted with either a Prodigy, Prodigy MRI or Proclaim Elite IPG
Mean Change in Pain Catastrophizing From Baseline to 6 Months Post-permanent Implant, Assessed by the Pain Catastrophizing Scale (PCS) Baseline	25.6 score on a scale Standard Deviation 12.9
Mean Change in Pain Catastrophizing From Baseline to 6 Months Post-permanent Implant, Assessed by the Pain Catastrophizing Scale (PCS) 6 months	13.7 score on a scale Standard Deviation 12.2
Mean Change in Pain Catastrophizing From Baseline to 6 Months Post-permanent Implant, Assessed by the Pain Catastrophizing Scale (PCS) Change from baseline to 6 months	11.9 score on a scale Standard Deviation 11.8

SECONDARY outcome

Timeframe: Baseline to 6 Months

Population: The number of participants analyzed includes subjects who were available at the time of analysis

The State-Trait Anxiety inventory is a self-administered screening for anxiety. The STAI has 40 items, 20 items allocated to each of the S-Anxiety and T-Anxiety subscales. All items are rated on a 4-point scale from 1 to 4. It clearly differentiates between the temporary condition of "state anxiety" and the more general and long-standing quality of "trait anxiety" by providing a score for each. Higher scores suggest greater levels of anxiety. The range of possible scores for the STAI varies from a minimum score of 20 to a maximum score of 80 on both the trait and state subscales. The total score is the sum of the two subscales. STAI total scores range from 40 to 160.

Outcome measures

Outcome measures
Measure	All Enrolled Subjects n=180 Participants All subjects enrolled into the study with intent to treat with either a Prodigy, Prodigy MRI, or Proclaim Elite IPG. Prodigy, Prodigy MRI or Proclaim Elite IPG: Subjects will be permanently implanted with either a Prodigy, Prodigy MRI or Proclaim Elite IPG
Mean Change in Anxiety From Baseline to 6 Months Post-permanent Implant, Assessed by the State-Trait Anxiety Inventory (STAI) Baseline	87.1 score on a scale Standard Deviation 26.1
Mean Change in Anxiety From Baseline to 6 Months Post-permanent Implant, Assessed by the State-Trait Anxiety Inventory (STAI) 6 months	77.1 score on a scale Standard Deviation 24.7
Mean Change in Anxiety From Baseline to 6 Months Post-permanent Implant, Assessed by the State-Trait Anxiety Inventory (STAI) Change from baseline to 6 months	10.0 score on a scale Standard Deviation 21.6

SECONDARY outcome

Timeframe: Baseline to 6 Months

Population: The number of participants analyzed includes subjects who were available at the time of analysis

The PHQ9 is a multipurpose, validated instrument for screening, diagnosing, monitoring and measuring the severity of depression. The questionnaire consists of 9 questions that rate the frequency of the symptoms of depression. A follow up non-scored question screens and assigns weight to the degree to which depressive problems have affected the patient's level of function. The responses range between 4 choices (0=not at all to 3=nearly every day). Higher scores indicate a higher likelihood of major depression. PHQ-9 scores range from 0 (min) to 27 (max).

Outcome measures

Outcome measures
Measure	All Enrolled Subjects n=180 Participants All subjects enrolled into the study with intent to treat with either a Prodigy, Prodigy MRI, or Proclaim Elite IPG. Prodigy, Prodigy MRI or Proclaim Elite IPG: Subjects will be permanently implanted with either a Prodigy, Prodigy MRI or Proclaim Elite IPG
Mean Change in Depression From Baseline to 6 Months Post-permanent Implant, Assessed by the Patient Health Questionnaire-9 (PHQ9) Baseline	10.5 score on a scale Standard Deviation 6.5
Mean Change in Depression From Baseline to 6 Months Post-permanent Implant, Assessed by the Patient Health Questionnaire-9 (PHQ9) 6 months	7.6 score on a scale Standard Deviation 6.5
Mean Change in Depression From Baseline to 6 Months Post-permanent Implant, Assessed by the Patient Health Questionnaire-9 (PHQ9) Change from baseline to 6 months	3.0 score on a scale Standard Deviation 5.5

SECONDARY outcome

Timeframe: Baseline to 6 Months

Population: The number of participants analyzed includes subjects who were available at the time of analysis

The TSK is a 11-item self-report checklist using a 4-point Likert scale that was developed from the original 17-item checklist (Miller, Kopri \& Todd, 1991) as a measure of fear or movement or (re)injury. The scale is based on the model of fear avoidance, fear of work related activities, fear of movement and fear of re-injury. The TSK has also been linked to elements of catastrophic thinking. The scale can be useful in measuring unhelpful thoughts and beliefs about pain in people with chronic pain. Total TSK-11 scores range from 11-44 points. Higher scores represent worse outcomes.

Outcome measures

Outcome measures
Measure	All Enrolled Subjects n=180 Participants All subjects enrolled into the study with intent to treat with either a Prodigy, Prodigy MRI, or Proclaim Elite IPG. Prodigy, Prodigy MRI or Proclaim Elite IPG: Subjects will be permanently implanted with either a Prodigy, Prodigy MRI or Proclaim Elite IPG
Mean Change in Fear Avoidance From Baseline to 6 Months Post-permanent Implant, Assessed by the Tampa Scale for Kinesiophobia (TSK) Change from baseline to 6 months	3.8 score on a scale Standard Deviation 6.7
Mean Change in Fear Avoidance From Baseline to 6 Months Post-permanent Implant, Assessed by the Tampa Scale for Kinesiophobia (TSK) Baseline	28.7 score on a scale Standard Deviation 7.8
Mean Change in Fear Avoidance From Baseline to 6 Months Post-permanent Implant, Assessed by the Tampa Scale for Kinesiophobia (TSK) 6 months	24.9 score on a scale Standard Deviation 7.2

SECONDARY outcome

Timeframe: Baseline to 6 Months

Population: The number of participants analyzed includes subjects who were available at the time of analysis

The MOS sleep scale is intended to assess the extent of sleep problems and measures 6 dimensions of sleep, including initiation, maintenance, quantity, adequacy, drowsiness and respiratory impairments. It includes 12 questions with the first question assessing how long it takes the subject to fall asleep. The second question asks how many hours each night the subject slept. The remaining 10 questions have a range of 6 responses from 1="all of the time" to 6="none of the time". The scale is self-administered and validated. MOS Sleep scale scores range from 0 (min) to 100 (max). Higher scores represent worse outcomes.

Outcome measures

Outcome measures
Measure	All Enrolled Subjects n=180 Participants All subjects enrolled into the study with intent to treat with either a Prodigy, Prodigy MRI, or Proclaim Elite IPG. Prodigy, Prodigy MRI or Proclaim Elite IPG: Subjects will be permanently implanted with either a Prodigy, Prodigy MRI or Proclaim Elite IPG
Mean Change in Sleep From Baseline to 6 Months Post-permanent Implant, Assessed by the Medical Outcome Study (MOS) Sleep Scale Baseline	52.6 score on a scale Standard Deviation 21.8
Mean Change in Sleep From Baseline to 6 Months Post-permanent Implant, Assessed by the Medical Outcome Study (MOS) Sleep Scale 6 months	45.0 score on a scale Standard Deviation 23.2
Mean Change in Sleep From Baseline to 6 Months Post-permanent Implant, Assessed by the Medical Outcome Study (MOS) Sleep Scale Change from baseline to 6 months	7.5 score on a scale Standard Deviation 18.8

SECONDARY outcome

Timeframe: Baseline to 6 Months

Population: The number of participants analyzed includes subjects who were available at the time of analysis

The PROMIS Physical Function short form is an 8-item instrument designed to measure physical capability rather than actual performance of physical activities. The scale measures universal physical function rather than disease-specific impairment and assesses current function rather than function over a specified time period. Each question has five potential response options ranging in value from one to five to give a total score ranging from 8 to 40. Scores are converted into t-scores where the average for the general US population is 50 and the SD is 10. Higher scores indicate better physical function.