Back Pain With Radiation
Conditions
Keywords
lumbago, low back pain, leg pain
Brief summary
This study is to objectively evaluate the success of a spinal cord stimulator (SCS) trial using testing (DSSEP) to determine if the paresthesia (tingling sensation) or pain reduction achieved correlates with the degree of stimulation.
Detailed description
The SCS trial leads will be placed as per standard of care, using fluoroscopic guidance and leads will be checked for proper positioning. Leads will be tested for appropriate paresthesia coverage of the patient's painful area(s), using multiple electrode configurations and lead positions (dependent on the location of the pain). After the leads are secured, the patient will be sent to the recovery room where the DSSEP test will be performed. A technologist will glue/tape recording electrodes to the patient's head, neck, back or legs. One or two stimulating electrodes are also placed on the patient's leg. Each electrode is checked with a meter to ensure proper functioning. Pulsing stimulus will start in one of the stimulating electrodes. Each time a different area is tested, the pulsing will be started again. Each area tested will take 10-15 minutes. The painful dermatomal distribution area, specific to each patient will be used for dermatomal SSEP stimulation. Placement will be correlated with nerve roots involved with the corresponding dermatomes. Measurements will be obtained to determine collision criteria.
Interventions
DEVICEDSSEP
Collision testing after the placement of SCS leads
Sponsors
University of Toledo Health Science Campus
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
DIAGNOSTIC
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
A subject will be eligible for inclusion in this study only if all the following criteria apply: A. Subject understands the procedures, agrees to participate in the study, and has signed and dated the informed consent form prior to the initiation of any study-related activities. B. Subjects are male or female greater than 18 years old at the time of screening visit. C. Pain in one or both lower extremities. D. Pain is not responding to conservative treatment such as physical therapy or medications. E. Average pain rating of at least 4 on a scale 0 to 10, on average, prior to enrollment in the study. F. Patient is mentally competent to make decisions.
Exclusion criteria
A subject will not be eligible for inclusion in this study if any of the following criteria apply: A. Female subject with childbearing potential (a premenopausal female, who is not surgically sterile). B. Subjects who poorly cooperate or have any cognitive impairment. C. Patient with severe concomitant depression. D. Inability to communicate adequately with physician and /or study coordinator. E. Patient is diagnosed with a psychiatric condition that will likely interfere with diagnostic accuracy of the workup protocol or with recovery following the anticipated procedure
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Number of Participants With Positive Collision | Day 1 | Positive collision: 75% or greater decrease in amplitude from the baseline waveform. Centroparietal (CPz)-Popliteal Fossa (Fpz) cortical montage (images) will be used as primary montage to evaluate collision results. |
Countries
United States
Participant flow
Recruitment details
Participants were recruited from subjects scheduled to receive the Spinal Cord stimulator (SCS) trial leads at the University of Toledo Medical Center.
Pre-assignment details
6 participants were enrolled.
Participants by arm
| Arm | Count |
|---|---|
| DSSEP DSSEP testing after SCS trial lead placement
DSSEP: Collision testing after the placement of SCS leads | 6 |
| Total | 6 |
Withdrawals & dropouts
| Period | Reason | FG000 |
|---|---|---|
| Overall Study | Withdrawal by Subject | 1 |
Baseline characteristics
| Characteristic | DSSEP | — |
|---|---|---|
| Age, Categorical <=18 years | 0 Participants | — |
| Age, Categorical >=65 years | 0 Participants | — |
| Age, Categorical Between 18 and 65 years | 6 Participants | — |
| Race and Ethnicity Not Collected | — | — Participants |
| Sex: Female, Male Female | 4 Participants | — |
| Sex: Female, Male Male | 2 Participants | — |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | 0 / 0 |
| other Total, other adverse events | 0 / 6 |
| serious Total, serious adverse events | 0 / 6 |
Outcome results
Primary
Number of Participants With Positive Collision
Positive collision: 75% or greater decrease in amplitude from the baseline waveform. Centroparietal (CPz)-Popliteal Fossa (Fpz) cortical montage (images) will be used as primary montage to evaluate collision results.
Time frame: Day 1
Population: 5 participants completed DSSEP testing after placement of SCS Trial leads.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| DSSEP | Number of Participants With Positive Collision | 2 Participants |