A Phase 4 interventional study of Spinal Cord Stimulation in Back Pain and Leg Pain, sponsored by MedtronicNeuro. Completed at 10 sites in United States. Open to participants aged 22 Years and older. Per ClinicalTrials.gov, last updated 2020-04-15.
Sponsored by MedtronicNeuro · Phase 4, Interventional, and Treatment
This study characterized the effects of amplitude on subject satisfaction and pain relief in subjects being treated by SCS.
This feasibility study assessed the following outcomes:
Exclusion Criteria:
Each subject was programmed to 4 different amplitude settings: 80%, 60%, 40% and 20% of perception threshold amplitude
Device: Spinal Cord Stimulation
Programming
SCS Therapy Satisfaction
To characterize the effect of four different amplitude settings on baseline SCS therapy satisfaction. At each follow-up visit, the following question was asked to measure satisfaction: "Overall how satisfied or unsatisfied are you with this therapy?". The response choices were as follows: "very satisfied", "somewhat satisfied", "neutral", "somewhat unsatisfied", "very unsatisfied". Each subject was considered to have maintained their baseline SCS therapy satisfaction if they selected the response "very satisfied", "somewhat satisfied", or "neutral", otherwise they were considered dissatisfied with the therapy. The first visit in which each subject reported dissatisfaction of the therapy was recorded. The amplitude used during the prior visit was then considered to be the minimum amplitude that maintained each subject's therapy satisfaction. The frequency and percentage of subjects' that maintained baseline satisfaction were reported at each amplitude level.
Time frame: 8 weeks
Number of Participants Maintaining Baseline Pain as Measured on the Visual Analog Scale (VAS)
To characterize the effect of four different amplitude settings on baseline pain relief. During each follow-up period the VAS pain score was recorded once a day, on a multi-day diary, where subjects rated their pain by making a vertical slash mark through the 0-10 cm line that best described their pain during the last 24 hours, with 0 = No pain and 10 = Worst pain imaginable. The higher VAS pain score represented worse pain. The average VAS pain scores from the last 3 days of the diary prior to the scheduled visit was used for analysis. Each subject was considered to have maintained their baseline pain if there was less than a 2 point increase in their average pain score at the follow-up period. The amplitude used during the prior visit was then considered to be the minimum amplitude that maintained the subject's pain relief. The frequency and percentage of subjects' that maintained their average baseline VAS pain score were reported at each amplitude level.
Time frame: 8 weeks
| Milestone | Spinal Cord Stimulation |
|---|---|
| Started | 30 |
| Completed | 30 |
| Not completed | 0 |
To characterize the effect of four different amplitude settings on baseline SCS therapy satisfaction. At each follow-up visit, the following question was asked to measure satisfaction: "Overall how satisfied or unsatisfied are you with this therapy?". The response choices were as follows: "very satisfied", "somewhat satisfied", "neutral", "somewhat unsatisfied", "very unsatisfied". Each subject was considered to have maintained their baseline SCS therapy satisfaction if they selected the response "very satisfied", "somewhat satisfied", or "neutral", otherwise they were considered dissatisfied with the therapy. The first visit in which each subject reported dissatisfaction of the therapy was recorded. The amplitude used during the prior visit was then considered to be the minimum amplitude that maintained each subject's therapy satisfaction. The frequency and percentage of subjects' that maintained baseline satisfaction were reported at each amplitude level.
| Participants | Spinal Cord Stimulation |
|---|---|
| Baseline | 6 |
| 80% perception threshold | 2 |
| 60% perception threshold | 1 |
| 40% perception threshold | 0 |
| 20% perception threshold | 21 |
To characterize the effect of four different amplitude settings on baseline pain relief. During each follow-up period the VAS pain score was recorded once a day, on a multi-day diary, where subjects rated their pain by making a vertical slash mark through the 0-10 cm line that best described their pain during the last 24 hours, with 0 = No pain and 10 = Worst pain imaginable. The higher VAS pain score represented worse pain. The average VAS pain scores from the last 3 days of the diary prior to the scheduled visit was used for analysis. Each subject was considered to have maintained their baseline pain if there was less than a 2 point increase in their average pain score at the follow-up period. The amplitude used during the prior visit was then considered to be the minimum amplitude that maintained the subject's pain relief. The frequency and percentage of subjects' that maintained their average baseline VAS pain score were reported at each amplitude level.
| Participants | Spinal Cord Stimulation |
|---|---|
| Baseline | 5 |
| 80% perception threshold | 3 |
| 60% perception threshold | 1 |
| 40% perception threshold | 2 |
| 20% perception threshold | 19 |
Collected over Adverse events were collected from enrollment to study discontinuation with an average of 2.2 months. Non-serious events are listed at a 0% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Spinal Cord Stimulation | 0/30 (0%) | 0/30 (0%) | 5/30 (16.7%) |
| Event | Spinal Cord Stimulation |
|---|---|
| Device stimulation issueProduct Issues | 3/30 |
| Inadequate analgesiaGeneral disorders | 1/30 |
| Back painMusculoskeletal and connective tissue disorders | 1/30 |
| Age, Continuous(years) | Spinal Cord Stimulation |
|---|---|
| Mean | 65.1 ± 11.9 |
| Sex: Female, Male(Participants) | Spinal Cord Stimulation |
|---|---|
| Female | 23 |
| Male | 7 |
| Race (NIH/OMB)(Participants) | Spinal Cord Stimulation |
|---|---|
| American Indian or Alaska Native | 0 |
| Asian | 0 |
| Native Hawaiian or Other Pacific Islander | 0 |
| Black or African American | 0 |
| White | 30 |
| More than one race | 0 |
| Unknown or Not Reported | 0 |
| Region of Enrollment(participants) | Spinal Cord Stimulation |
|---|---|
| United States | 30 |
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MedtronicNeuro