An interventional study of Spinal cord stimulation in Chronic Pain, Failed Back Surgery Syndrome and Complex Regional Pain Syndromes, sponsored by University of Michigan. Completed at 1 site in United States. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-03-27.
Sponsored by University of Michigan · Not applicable, Interventional, and Treatment
Doctors sometimes treat chronic pain with devices that send mild electrical currents into the spinal cord. This type of treatment is referred to as neurostimulation. A common form of neurostimulation therapy is spinal cord stimulation (SCS). In this study, how SCS affects pain processing and relieves pain will be studied. Multiple forms of SCS will be examined in chronic pain patients who are receiving SCS from their own doctors as part of their standard of care. During the study, participants will be asked to complete a variety of evaluations at certain time points.
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This study's enrollment of 34 is below the median of 60 across 2,161 interventional studies indexed under Chronic Pain.
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Exclusion criteria:
Participants will be randomized to one of six treatment arms. Participants will receive burst, kHz, tonic, and sham spinal cord stimulation (SCS). Each treatment will be applied for a duration of seven days. Participants will be blinded during programming.
Device: Spinal cord stimulation
Participants will be randomized to one of six treatment arms. Participants will receive burst, kHz, tonic, and sham spinal cord stimulation (SCS). Each treatment will be applied for a duration of seven days. Participants will be blinded during programming.
Device: Spinal cord stimulation
Participants will be randomized to one of six treatment arms. Participants will receive burst, kHz, tonic, and sham spinal cord stimulation (SCS). Each treatment will be applied for a duration of seven days. Participants will be blinded during programming.
Device: Spinal cord stimulation
Participants will be randomized to one of six treatment arms. Participants will receive burst, kHz, tonic, and sham spinal cord stimulation (SCS). Each treatment will be applied for a duration of seven days. Participants will be blinded during programming.
Device: Spinal cord stimulation
Participants will be randomized to one of six treatment arms. Participants will receive burst, kHz, tonic, and sham spinal cord stimulation (SCS). Each treatment will be applied for a duration of seven days. Participants will be blinded during programming.
Device: Spinal cord stimulation
Participants will be randomized to one of six treatment arms. Participants will receive burst, kHz, tonic, and sham spinal cord stimulation (SCS). Each treatment will be applied for a duration of seven days. Participants will be blinded during programming.
Device: Spinal cord stimulation
The spinal cord stimulation (SCS) system will be programmed to deliver, according to the randomization status of the participant, burst, kHz, tonic, and sham stimulation.
Spinal Cord Stimulation (SCS)-Induced Changes in Temporal Summation (TS)
TS refers to an increased perception of pain in response to sequential stimuli of equal physical strength. At the end of each treatment period, TS scores were calculated by subtracting the average pain rating of the single-stimulus trials from the average pain rating of the ten-stimuli trials. If the difference is a positive number, the researchers will conclude that there was pain summation, where larger numbers will indicate increased pain summation or TS. If the difference is zero or a negative number, the researchers will conclude that there was no pain summation or TS.
Time frame: Up to 30 days
SCS-induced Changes in Temporal Summation (TS) - 50Hz (Tonic)-SCS to Sham-SCS
Temporal summation (TS) refers to an increased perception of pain in response to sequential stimuli of equal physical strength. At the end of each treatment period, TS scores were calculated by subtracting the average pain rating of the single-stimulus trials from the average pain rating of the ten-stimulus trials. TS scores range from a minimum of -100 to a maximum of 100. If the difference was a positive number, then pain summation was present, where larger numbers indicate increased pain summation or TS. If the difference was zero or a negative number, then no pain summation or TS was present. Results show in-participant comparisons calculated as the Tonic-SCS score minus the Sham-SCS score for each individual across the entire study, regardless of sequence. Negative values indicate improvement (i.e., reduced pain summation or TS with Tonic-SCS relative to Sham-SCS) and positive values indicate worsening (i.e., increased pain summation or TS with Tonic-SCS relative to Sham-SCS).
Time frame: Up to 30 days
SCS-induced Changes in Temporal Summation (TS) - 1kHz-SCS to Sham-SCS
Temporal summation (TS) refers to an increased perception of pain in response to sequential stimuli of equal physical strength. At the end of each treatment period, TS scores were calculated by subtracting the average pain rating of the single-stimulus trials from the average pain rating of the ten-stimulus trials. The TS scores range from a minimum of -100 to a maximum of 100. If the difference was a positive number, then pain summation was present, where larger numbers indicate increased pain summation or TS. If the difference was zero or a negative number, then no pain summation or TS was present. Results show in-participant comparisons calculated as the kHz-SCS score minus the Sham-SCS score for each individual across the entire study, regardless of sequence. Negative values indicate improvement (i.e., reduced pain summation or TS with kHz-SCS relative to Sham-SCS) and positive values indicate worsening (i.e., increased pain summation or TS with kHz-SCS relative to Sham-SCS).
Time frame: Up to 30 days
Spinal Cord Stimulation (SCS)-Induced Changes in Temporal Summation (TS) - Burst-SCS to Sham-SCS
Temporal summation (TS) refers to an increased perception of pain in response to sequential stimuli of equal physical strength. At the end of each treatment period, TS scores were calculated by subtracting the average pain rating of the single-stimulus trials from the average pain rating of the ten-stimulus trials. TS scores range from a minimum of -100 to a maximum of 100. If the difference was a positive number, then pain summation was present, where larger numbers indicate increased pain summation or TS. If the difference was zero or a negative number, then no pain summation or TS was present. Results show in-participant comparisons calculated as the Burst-SCS score minus the Sham-SCS score for each individual across the entire study, regardless of sequence. Negative values indicate improvement (i.e., reduced pain summation or TS with Burst-SCS relative to Sham-SCS) and positive values indicate worsening (i.e., increased pain summation or TS with Burst-SCS relative to Sham-SCS).
Time frame: Up to 30 days
Recruitment period was between October 2021 - May 2024.
| Milestone | Burst / 1kHz / Sham / 50Hz (Tonic) | Burst / Sham / 1kHz / 50Hz (Tonic) | 1kHz / Sham / Burst / 50Hz (Tonic) | 1kHz / Burst / Sham / 50Hz (Tonic) | Sham / Burst / 1kHz / 50Hz (Tonic) | Sham / 1kHz / Burst / 50Hz (Tonic) |
|---|---|---|---|---|---|---|
| Started | 4 | 4 | 5 | 4 | 4 | 4 |
| Double-blind treatment period 1 | 4 | 4 | 5 | 4 | 4 | 4 |
| Double-blind treatment period 2 | 3 | 4 | 5 | 4 | 4 | 4 |
| Double-blind treatment period 3 | 3 | 4 | 5 | 4 | 4 | 4 |
| Double-blind treatment period 4 | 3 | 4 | 5 | 4 | 4 | 4 |
| Completed | 3 | 4 | 5 | 4 | 4 | 4 |
| Not completed | 1 | 0 | 0 | 0 | 0 | 0 |
| Withdrew: Withdrawal by subject | 1 | 0 | 0 | 0 | 0 | 0 |
TS refers to an increased perception of pain in response to sequential stimuli of equal physical strength. At the end of each treatment period, TS scores were calculated by subtracting the average pain rating of the single-stimulus trials from the average pain rating of the ten-stimuli trials. If the difference is a positive number, the researchers will conclude that there was pain summation, where larger numbers will indicate increased pain summation or TS. If the difference is zero or a negative number, the researchers will conclude that there was no pain summation or TS.
| score on a scale | 1kHz | Burst | 50Hz (Tonic) | Sham |
|---|---|---|---|---|
| TS256 - Pain Site | 3.67 (0.75 to 9.50) | 3.33 (1.33 to 5.50) | 3.67 (0.00 to 10.9) | 3.33 (1.33 to 14.3) |
| TS512 - Pain Site | 8.33 (2.17 to 20.3) | 5.67 (1.33 to 10.0) | 8.33 (2.00 to 12.3) | 7.67 (3.33 to 17.7) |
| TS256 - Control Site | 1.67 (0.00 to 11.7) | 3.50 (0.00 to 8.75) | 1.17 (0.00 to 12.0) | 1.50 (0.00 to 16.2) |
| TS512 - Control Site | 3.50 (0.67 to 23.7) | 4.67 (0.08 to 13.0) | 1.50 (0.00 to 12.4) | 3.17 (0.25 to 16.2) |
Temporal summation (TS) refers to an increased perception of pain in response to sequential stimuli of equal physical strength. At the end of each treatment period, TS scores were calculated by subtracting the average pain rating of the single-stimulus trials from the average pain rating of the ten-stimulus trials. TS scores range from a minimum of -100 to a maximum of 100. If the difference was a positive number, then pain summation was present, where larger numbers indicate increased pain summation or TS. If the difference was zero or a negative number, then no pain summation or TS was present. Results show in-participant comparisons calculated as the Tonic-SCS score minus the Sham-SCS score for each individual across the entire study, regardless of sequence. Negative values indicate improvement (i.e., reduced pain summation or TS with Tonic-SCS relative to Sham-SCS) and positive values indicate worsening (i.e., increased pain summation or TS with Tonic-SCS relative to Sham-SCS).
| score on a scale | Participants Who Received Tonic-SCS and Sham-SCS |
|---|---|
| Temporal summation with 256mN pressure at primary pain (affected) site | 0.283 (-5.98 to 6.55) |
| Temporal summation with 512mN pressure at primary pain (affected) site | -2.35 (-8.92 to 4.23) |
| Temporal summation with 256mN pressure at control (unaffected) site | 0.758 (-3.36 to 4.88) |
| Temporal summation with 512mN pressure at control (unaffected) site | 1.318 (-4.29 to 6.92) |
Temporal summation (TS) refers to an increased perception of pain in response to sequential stimuli of equal physical strength. At the end of each treatment period, TS scores were calculated by subtracting the average pain rating of the single-stimulus trials from the average pain rating of the ten-stimulus trials. The TS scores range from a minimum of -100 to a maximum of 100. If the difference was a positive number, then pain summation was present, where larger numbers indicate increased pain summation or TS. If the difference was zero or a negative number, then no pain summation or TS was present. Results show in-participant comparisons calculated as the kHz-SCS score minus the Sham-SCS score for each individual across the entire study, regardless of sequence. Negative values indicate improvement (i.e., reduced pain summation or TS with kHz-SCS relative to Sham-SCS) and positive values indicate worsening (i.e., increased pain summation or TS with kHz-SCS relative to Sham-SCS).
| score on a scale | Participants Who Received kHz-SCS and Sham-SCS |
|---|---|
| Temporal summation with 256mN pressure at primary pain (affected) site | -4.432 (-10.59 to 1.72) |
| Temporal summation with 512mN pressure at primary pain (affected) site | -3.90 (-10.37 to 2.58) |
| Temporal summation with 256mN pressure at control (unaffected) site | -2.737 (-6.78 to 1.31) |
| Temporal summation with 512mN pressure at control (unaffected) site | -0.917 (-6.42 to 4.59) |
Temporal summation (TS) refers to an increased perception of pain in response to sequential stimuli of equal physical strength. At the end of each treatment period, TS scores were calculated by subtracting the average pain rating of the single-stimulus trials from the average pain rating of the ten-stimulus trials. TS scores range from a minimum of -100 to a maximum of 100. If the difference was a positive number, then pain summation was present, where larger numbers indicate increased pain summation or TS. If the difference was zero or a negative number, then no pain summation or TS was present. Results show in-participant comparisons calculated as the Burst-SCS score minus the Sham-SCS score for each individual across the entire study, regardless of sequence. Negative values indicate improvement (i.e., reduced pain summation or TS with Burst-SCS relative to Sham-SCS) and positive values indicate worsening (i.e., increased pain summation or TS with Burst-SCS relative to Sham-SCS).
| score on a scale | Participants Who Received Burst-SCS and Sham-SCS |
|---|---|
| Temporal summation with 256mN pressure at primary pain (affected) site | -2.304 (-8.71 to 4.10) |
| Temporal summation with 512mN pressure at primary pain (affected) site | -5.03 (-11.76 to 1.71) |
| Temporal summation with 256mN pressure at control (unaffected) site | 0.621 (-3.59 to 4.83) |
| Temporal summation with 512mN pressure at control (unaffected) site | -1.780 (-7.51 to 3.95) |
Collected over 30 days. Non-serious events are listed at a 0% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Burst | 0/25 (0%) | 0/25 (0%) | 3/25 (12%) |
| Kilohertz (kHz) | 0/24 (0%) | 0/24 (0%) | 0/24 (0%) |
| Sham | 0/24 (0%) | 0/24 (0%) | 0/24 (0%) |
| Tonic | 0/24 (0%) | 0/24 (0%) | 2/24 (8.3%) |
| Event | Burst | Kilohertz (kHz) | Sham | Tonic |
|---|---|---|---|---|
| Uncomfortable paresthesiaNervous system disorders | 1/25 | 0/24 | 0/24 | 1/24 |
| Abnormal sensationNervous system disorders | 1/25 | 0/24 | 0/24 | 1/24 |
| Pain at implantable pulse generator (IPG) siteNervous system disorders | 1/25 | 0/24 | 0/24 | 0/24 |
| Age, Continuous(years) | Burst / 1kHz / Sham / 50Hz (Tonic) | Burst / Sham / 1kHz / 50Hz (Tonic) | 1kHz / Sham / Burst / 50Hz (Tonic) | 1kHz / Burst / Sham / 50Hz (Tonic) | Sham / Burst / 1kHz / 50Hz (Tonic) | Sham / 1kHz / Burst / 50Hz (Tonic) | Total |
|---|---|---|---|---|---|---|---|
| Mean | 56.8 ± 11.3 | 55.3 ± 11.7 | 52.8 ± 16.8 | 51.3 ± 16.8 | 57.5 ± 9.1 | 53.5 ± 5.4 | 54.4 ± 11.6 |
| Sex: Female, Male(Participants) | Burst / 1kHz / Sham / 50Hz (Tonic) | Burst / Sham / 1kHz / 50Hz (Tonic) | 1kHz / Sham / Burst / 50Hz (Tonic) | 1kHz / Burst / Sham / 50Hz (Tonic) | Sham / Burst / 1kHz / 50Hz (Tonic) | Sham / 1kHz / Burst / 50Hz (Tonic) | Total |
|---|---|---|---|---|---|---|---|
| Female | 3 | 2 | 0 | 0 | 2 | 3 | 10 |
| Male | 1 | 2 | 5 | 4 | 2 | 1 | 15 |
| Ethnicity (NIH/OMB)(Participants) | Burst / 1kHz / Sham / 50Hz (Tonic) | Burst / Sham / 1kHz / 50Hz (Tonic) | 1kHz / Sham / Burst / 50Hz (Tonic) | 1kHz / Burst / Sham / 50Hz (Tonic) | Sham / Burst / 1kHz / 50Hz (Tonic) | Sham / 1kHz / Burst / 50Hz (Tonic) | Total |
|---|---|---|---|---|---|---|---|
| Hispanic or Latino | 0 | 0 | 0 | 0 | 1 | 0 | 1 |
| Not Hispanic or Latino | 4 | 4 | 5 | 4 | 3 | 4 | 24 |
| Unknown or Not Reported | 0 | 0 | 0 | 0 | 0 | 0 | 0 |
| Race (NIH/OMB)(Participants) | Burst / 1kHz / Sham / 50Hz (Tonic) | Burst / Sham / 1kHz / 50Hz (Tonic) | 1kHz / Sham / Burst / 50Hz (Tonic) | 1kHz / Burst / Sham / 50Hz (Tonic) | Sham / Burst / 1kHz / 50Hz (Tonic) | Sham / 1kHz / Burst / 50Hz (Tonic) | Total |
|---|---|---|---|---|---|---|---|
| American Indian or Alaska Native | 0 | 0 | 0 | 0 | 0 | 0 | 0 |
| Asian | 0 | 0 | 0 | 0 | 0 | 0 | 0 |
| Native Hawaiian or Other Pacific Islander | 0 | 0 | 0 | 0 | 0 | 0 | 0 |
| Black or African American | 1 | 0 | 2 | 0 | 1 | 0 | 4 |
| White | 3 | 3 | 3 | 4 | 3 | 3 | 19 |
| More than one race | 0 | 1 | 0 | 0 | 0 | 1 | 2 |
| Unknown or Not Reported | 0 | 0 | 0 | 0 | 0 | 0 | 0 |
| Region of Enrollment(Participants) | Burst / 1kHz / Sham / 50Hz (Tonic) | Burst / Sham / 1kHz / 50Hz (Tonic) | 1kHz / Sham / Burst / 50Hz (Tonic) | 1kHz / Burst / Sham / 50Hz (Tonic) | Sham / Burst / 1kHz / 50Hz (Tonic) | Sham / 1kHz / Burst / 50Hz (Tonic) | Total |
|---|---|---|---|---|---|---|---|
| United States | 4 | 4 | 5 | 4 | 4 | 4 | 25 |
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