Chronic Pain, Complex Regional Pain Syndromes, Failed Back Surgery Syndrome, Neuropathic Pain
Conditions
Keywords
Spinal cord stimulation, chronic pain
Brief summary
The purpose of this study is to demonstrate safety and efficacy of a new spinal cord stimulation paddle electrode which is able to target the dorsal horns, dorsal nerve roots, and dorsal columns. The research electrode (Study Electrode) is designed to answer basic physiological clinical research questions. It may inform future device therapy development, but the Study Electrode is not a product that will be marketed or sold. The Investigators believe the protocol is a Non-Significant Risk study answering basic physiological research questions, which may be performed under hospital IRB approval.
Interventions
DEVICEHD Study Electrode
The HD Study Electrode is an array of 8 columns of stimulation contacts arranged in 8 rows with a low-volume electrode body. This array of stimulation electrodes contact patterns of bi-poles and tri-poles may be applied to the spinal cord for assessment of dermatomal selective stimulation patterns.
Sponsors
Albany Medical College
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
DEVICE_FEASIBILITY
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 90 Years
Healthy volunteers
No
Inclusion criteria
* patients undergoing a spinal cord stimulation procedure for neuropathic pain * must be fluent in English as well as mentally competent to read and answer the questionnaires, as well as complete pain assessment exams. * subjects must be able to give informed consent.
Exclusion criteria
* patients who are not undergoing thoracic spinal cord stimulation for chronic neuropathic pain
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Numeric Rating Scale (NRS) | 3 months | Patients rate their pain on a scale from 0-10; 0 being not in pain and 10 being worst pain imaginable. A higher score indicates worse outcome. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| McGill Pain Questionnaire (MPQ) | 3 month | Patients select words that describe their pain. There are a total of 15 words. A higher score (more words selected) indicates worse outcome with a range from 0-15. |
| Oswestry Disability Index (ODI) | 3 months | This is a multiple choice style scale where patients are presented with an activity and asked to select a description which best matches their ability to perform that activity. Multiple choice options are then scored on a scale from 0-5; where 0 is no issues performing the activity and 5 is cannot perform activity. A higher score indicates worse outcome. The range in scores is from 0-100. |
| Pain Catastrophizing Scale (PCS) | 3 months | Patients are presented with a series of statements and they are asked to rate on a scale from 0-4, how often these statements apply to them when they are in pain. 0= never and 4= always. A higher score indicates worse outcome. Scores range from 0-52. |
| Beck Depression Index (BDI) | 3 months | This is a multiple choice style scale where patients are asked to select a statement related to a feeling of sadness or a component of depression. Multiple choice options are then scored on a scale from 0-3; where 0 is they do not feel that way and 3 is they do feel that way. A higher score indicates worse outcome. Scores range from 0-63 |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Study Group Twelve patients offered SCS for standard of care were also invited to participate in this study, in which a study electrode was temporarily placed intraoperatively and neuromonitoring was done per our routine standard-of-care
HD Study Electrode: The HD Study Electrode is an array of 8 columns of stimulation contacts arranged in 8 rows with a low-volume electrode body. This array of stimulation electrodes contact patterns of bi-poles and tri-poles may be applied to the spinal cord for assessment of dermatomal selective stimulation patterns. | 12 |
| Total | 12 |
Withdrawals & dropouts
| Period | Reason | FG000 |
|---|---|---|
| Overall Study | Lost to Follow-up | 3 |
Baseline characteristics
| Characteristic | Study Group |
|---|---|
| Age, Continuous | 52.75 years STANDARD_DEVIATION 14.75 |
| Ethnicity (NIH/OMB) Hispanic or Latino | 1 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 11 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 0 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants |
| Race (NIH/OMB) Asian | 0 Participants |
| Race (NIH/OMB) Black or African American | 0 Participants |
| Race (NIH/OMB) More than one race | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 0 Participants |
| Race (NIH/OMB) White | 12 Participants |
| Sex: Female, Male Female | 7 Participants |
| Sex: Female, Male Male | 5 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | 0 / 12 |
| other Total, other adverse events | 1 / 12 |
| serious Total, serious adverse events | 0 / 12 |
Outcome results
Primary
Numeric Rating Scale (NRS)
Patients rate their pain on a scale from 0-10; 0 being not in pain and 10 being worst pain imaginable. A higher score indicates worse outcome.
Time frame: 3 months
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Study Group | Numeric Rating Scale (NRS) | 5.333333333 score on a scale | Standard Deviation 2.115700942 |
Secondary
Beck Depression Index (BDI)
This is a multiple choice style scale where patients are asked to select a statement related to a feeling of sadness or a component of depression. Multiple choice options are then scored on a scale from 0-3; where 0 is they do not feel that way and 3 is they do feel that way. A higher score indicates worse outcome. Scores range from 0-63
Time frame: 3 months
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Study Group | Beck Depression Index (BDI) | 14.33333333 units on a scale | Standard Deviation 12.35198075 |
Secondary
McGill Pain Questionnaire (MPQ)
Patients select words that describe their pain. There are a total of 15 words. A higher score (more words selected) indicates worse outcome with a range from 0-15.
Time frame: 3 month
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Study Group | McGill Pain Questionnaire (MPQ) | 8.222222222 score on a scale | Standard Deviation 2.886751346 |
Secondary
Oswestry Disability Index (ODI)
This is a multiple choice style scale where patients are presented with an activity and asked to select a description which best matches their ability to perform that activity. Multiple choice options are then scored on a scale from 0-5; where 0 is no issues performing the activity and 5 is cannot perform activity. A higher score indicates worse outcome. The range in scores is from 0-100.
Time frame: 3 months
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Study Group | Oswestry Disability Index (ODI) | 50 units on a scale | Standard Deviation 17.13086882 |
Secondary
Pain Catastrophizing Scale (PCS)
Patients are presented with a series of statements and they are asked to rate on a scale from 0-4, how often these statements apply to them when they are in pain. 0= never and 4= always. A higher score indicates worse outcome. Scores range from 0-52.
Time frame: 3 months
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Study Group | Pain Catastrophizing Scale (PCS) | 18 units on a scale | Standard Deviation 12.43267584 |