Chronic Pain
Conditions
Brief summary
This purpose of this study is to evaluate the therapeutic efficacy of burst microdosing stimulation paradigms in patients with chronic pain.
Detailed description
This is a prospective, multicenter, randomized, double-blinded crossover study designed to compare conventional burst stimulation parameters to two different burst microdosing paradigms. Subjects will be randomized 1:1:1 to one of the three groups. Each group will evaluate all 3 stimulation paradigms in different order.
Interventions
DEVICEReprogramming of spinal cord stimulator (Proclaim or Prodigy SJM internal pulse generator) parameters according to study protocol
Stimulation parameters are reprogrammed from original values to study defined ones
Sponsors
Medizinische Einrichtungen der Universität Düsseldorf
Klinikum Duisburg GmbH
NKO Sint-Augustinus Antwerpen
Abbott Medical Devices
Study design
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Subject has been implanted with a commercially available SJM spinal cord stimulator for controlling chronic intractable pain associated with back and/or leg pain; * Subject has been exclusively using burst stimulation for at least three months; * Subject is 18 years of age or older; * Subject's pain-related medication regimen was stable in the 4 weeks prior to the screening evaluation; * Subject agrees not to add or increase pain-related medication from enrollment through the study duration; * Subject is willing to cooperate with the study requirements including compliance with the regimen and completion of all office visits;
Exclusion criteria
* Subject is currently participating in a clinical investigation study that includes an active treatment arm; * Subject is currently receiving, applying or considering seeking workers compensation, or is involved in disability litigation; * Subject has a non SJM neuromodulation device
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Visual Analog Scale (VAS) for Pain | assessed every 2 weeks after each intervention, for a total of 6 weeks | Standard evaluation of pain intensity. Scale goes from 0 to 100 millimiters. 0 means no pain, 100 means strongest imaginable pain |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| EQ-5D | assessed every 2 weeks after each intervention, for a total of 6 weeks | European Quality of life questionnaire 5 dimensions. Range goes from 0 to 1. 0 represents low quality of life, 1 represents high quality of life |
| Subject Preference | assessed 6 weeks after baseline at the last follow up visit | questionnaire to identify preferred stimulation paradigm. multiple choice questionnaire. Possible answers were * first intervention * second intervention * third intervention * no preference |
| Subject Satisfaction | assessed every 2 weeks after each intervention, for a total of 6 weeks | questionnaire on satisfaction with current therapy |
| Percentage of Participants With Adverse Events | assessed over 6 weeks of study participation | — |
Countries
Belgium, Germany
Participant flow
Recruitment details
29 patients were screened for elegibility between july 2016 and may 2017 Dusseldorf (GER) and Wilrijk (BEL)
Pre-assignment details
27 of the 29 participants received the study intervention. Of those did not receive study intervention, 1 did not meet inclusion/exlusion criteria and 1 was withdrawn for non compliance.
Participants by arm
| Arm | Count |
|---|---|
| All Subjects Baseline characteristics for all subjects | 29 |
| Total | 29 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 | FG002 |
|---|---|---|---|---|
| Third Intervention (2 Weeks) | emergenge of several new painful regions | 0 | 1 | 0 |
| Third Intervention (2 Weeks) | Protocol Violation | 1 | 0 | 0 |
Baseline characteristics
| Characteristic | All Subjects | — |
|---|---|---|
| Age, Continuous | 57.9 years STANDARD_DEVIATION 12 | — |
| Race and Ethnicity Not Collected | — | — Participants |
| Region of Enrollment Belgium | 12 participants | — |
| Region of Enrollment Germany | 17 participants | — |
| Sex: Female, Male Female | 18 Participants | — |
| Sex: Female, Male Male | 11 Participants | — |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk |
|---|---|---|---|
| deaths Total, all-cause mortality | 0 / 26 | 0 / 27 | 0 / 26 |
| other Total, other adverse events | 0 / 26 | 0 / 27 | 1 / 26 |
| serious Total, serious adverse events | 0 / 26 | 0 / 27 | 0 / 26 |
Outcome results
Primary
Visual Analog Scale (VAS) for Pain
Standard evaluation of pain intensity. Scale goes from 0 to 100 millimiters. 0 means no pain, 100 means strongest imaginable pain
Time frame: assessed every 2 weeks after each intervention, for a total of 6 weeks
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Microdosing A(5:5) | Visual Analog Scale (VAS) for Pain | 46.88 units on a scale | Standard Deviation 23.5 |
| Microdosing B: 5:10 | Visual Analog Scale (VAS) for Pain | 48.60 units on a scale | Standard Deviation 21.48 |
| Continuous | Visual Analog Scale (VAS) for Pain | 46.76 units on a scale | Standard Deviation 21.88 |
Secondary
EQ-5D
European Quality of life questionnaire 5 dimensions. Range goes from 0 to 1. 0 represents low quality of life, 1 represents high quality of life
Time frame: assessed every 2 weeks after each intervention, for a total of 6 weeks
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Microdosing A(5:5) | EQ-5D | 0.59 score on a scale | Standard Deviation 0.2 |
| Microdosing B: 5:10 | EQ-5D | 0.62 score on a scale | Standard Deviation 0.19 |
| Continuous | EQ-5D | 0.59 score on a scale | Standard Deviation 0.21 |
Secondary
Percentage of Participants With Adverse Events
Time frame: assessed over 6 weeks of study participation
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Microdosing A(5:5) | Percentage of Participants With Adverse Events | 3.7 percentage of patients with AE |
Secondary
Subject Preference
questionnaire to identify preferred stimulation paradigm. multiple choice questionnaire. Possible answers were * first intervention * second intervention * third intervention * no preference
Time frame: assessed 6 weeks after baseline at the last follow up visit
| Arm | Measure | Category | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Microdosing A(5:5) | Subject Preference | first intervention | 2 Participants |
| Microdosing A(5:5) | Subject Preference | second intervention | 1 Participants |
| Microdosing A(5:5) | Subject Preference | third intervention | 2 Participants |
| Microdosing A(5:5) | Subject Preference | no preference | 3 Participants |
| Microdosing B: 5:10 | Subject Preference | no preference | 1 Participants |
| Microdosing B: 5:10 | Subject Preference | first intervention | 1 Participants |
| Microdosing B: 5:10 | Subject Preference | third intervention | 2 Participants |
| Microdosing B: 5:10 | Subject Preference | second intervention | 5 Participants |
| Continuous | Subject Preference | no preference | 1 Participants |
| Continuous | Subject Preference | second intervention | 3 Participants |
| Continuous | Subject Preference | third intervention | 1 Participants |
| Continuous | Subject Preference | first intervention | 3 Participants |
Secondary
Subject Satisfaction
questionnaire on satisfaction with current therapy
Time frame: assessed every 2 weeks after each intervention, for a total of 6 weeks
| Arm | Measure | Category | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Microdosing A(5:5) | Subject Satisfaction | very dissatisfied | 1 Participants |
| Microdosing A(5:5) | Subject Satisfaction | satisfied | 9 Participants |
| Microdosing A(5:5) | Subject Satisfaction | Dissatisfied | 3 Participants |
| Microdosing A(5:5) | Subject Satisfaction | Neither satisfied or dissatisfied | 12 Participants |
| Microdosing A(5:5) | Subject Satisfaction | very satisfied | 0 Participants |
| Microdosing B: 5:10 | Subject Satisfaction | satisfied | 10 Participants |
| Microdosing B: 5:10 | Subject Satisfaction | Dissatisfied | 5 Participants |
| Microdosing B: 5:10 | Subject Satisfaction | Neither satisfied or dissatisfied | 8 Participants |
| Microdosing B: 5:10 | Subject Satisfaction | very dissatisfied | 1 Participants |
| Microdosing B: 5:10 | Subject Satisfaction | very satisfied | 1 Participants |
| Continuous | Subject Satisfaction | very satisfied | 1 Participants |
| Continuous | Subject Satisfaction | very dissatisfied | 2 Participants |
| Continuous | Subject Satisfaction | Dissatisfied | 7 Participants |
| Continuous | Subject Satisfaction | satisfied | 7 Participants |
| Continuous | Subject Satisfaction | Neither satisfied or dissatisfied | 8 Participants |