Trial Outcomes & Findings for Sensory Testing of Multiple Forms of Spinal Cord Stimulation for Pain (NCT NCT04732325)

Last Updated: 2026-03-27

Results Overview

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.

Recruitment status

COMPLETED

Study phase

Target enrollment

34 participants

Primary outcome timeframe

Up to 30 days

Results posted on

2026-03-27

Participant Flow

Recruitment period was between October 2021 - May 2024.

34 participants were enrolled but only 25 were randomized. 4 participants no longer met the inclusion criteria, 4 participants were lost to follow-up and 1 participant was withdrawn.

Participant milestones

Participant milestones
Measure	Burst / 1kHz / Sham / 50Hz (Tonic) Participants will be randomized to one of six treatment arms representing different sequences of four treatments/stimuli. 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. 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.	Burst / Sham / 1kHz / 50Hz (Tonic) Participants will be randomized to one of six treatment arms representing different sequences of four treatments/stimuli. 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. 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.	1kHz / Sham / Burst / 50Hz (Tonic) Participants will be randomized to one of six treatment arms representing different sequences of four treatments/stimuli. 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. 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.	1kHz / Burst / Sham / 50Hz (Tonic) Participants will be randomized to one of six treatment arms representing different sequences of four treatments/stimuli. 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. 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.	Sham / Burst / 1kHz / 50Hz (Tonic) Participants will be randomized to one of six treatment arms representing different sequences of four treatments/stimuli. 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. 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.	Sham / 1kHz / Burst / 50Hz (Tonic) Participants will be randomized to one of six treatment arms representing different sequences of four treatments/stimuli. 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. 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.
Overall Study STARTED	4	4	5	4	4	4
Overall Study Double-blind Treatment Period 1	4	4	5	4	4	4
Overall Study Double-blind Treatment Period 2	3	4	5	4	4	4
Overall Study Double-blind Treatment Period 3	3	4	5	4	4	4
Overall Study Double-blind Treatment Period 4	3	4	5	4	4	4
Overall Study COMPLETED	3	4	5	4	4	4
Overall Study NOT COMPLETED	1	0	0	0	0	0

Reasons for withdrawal

Reasons for withdrawal
Measure	Burst / 1kHz / Sham / 50Hz (Tonic) Participants will be randomized to one of six treatment arms representing different sequences of four treatments/stimuli. 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. 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.	Burst / Sham / 1kHz / 50Hz (Tonic) Participants will be randomized to one of six treatment arms representing different sequences of four treatments/stimuli. 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. 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.	1kHz / Sham / Burst / 50Hz (Tonic) Participants will be randomized to one of six treatment arms representing different sequences of four treatments/stimuli. 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. 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.	1kHz / Burst / Sham / 50Hz (Tonic) Participants will be randomized to one of six treatment arms representing different sequences of four treatments/stimuli. 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. 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.	Sham / Burst / 1kHz / 50Hz (Tonic) Participants will be randomized to one of six treatment arms representing different sequences of four treatments/stimuli. 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. 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.	Sham / 1kHz / Burst / 50Hz (Tonic) Participants will be randomized to one of six treatment arms representing different sequences of four treatments/stimuli. 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. 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.
Overall Study Withdrawal by Subject	1	0	0	0	0	0

Baseline Characteristics

Sensory Testing of Multiple Forms of Spinal Cord Stimulation for Pain

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Burst / 1kHz / Sham / 50Hz (Tonic) n=4 Participants Participants will be randomized to one of six treatment arms representing different sequences of four treatments/stimuli. 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. 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.	Burst / Sham / 1kHz / 50Hz (Tonic) n=4 Participants Participants will be randomized to one of six treatment arms representing different sequences of four treatments/stimuli. 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. 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.	1kHz / Sham / Burst / 50Hz (Tonic) n=5 Participants Participants will be randomized to one of six treatment arms representing different sequences of four treatments/stimuli. 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. 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.	1kHz / Burst / Sham / 50Hz (Tonic) n=4 Participants Participants will be randomized to one of six treatment arms representing different sequences of four treatments/stimuli. 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. 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.	Sham / Burst / 1kHz / 50Hz (Tonic) n=4 Participants Participants will be randomized to one of six treatment arms representing different sequences of four treatments/stimuli. 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. 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.	Sham / 1kHz / Burst / 50Hz (Tonic) n=4 Participants Participants will be randomized to one of six treatment arms representing different sequences of four treatments/stimuli. 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. 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.	Total n=25 Participants Total of all reporting groups
Age, Continuous	56.8 years STANDARD_DEVIATION 11.3 • n=56 Participants	55.3 years STANDARD_DEVIATION 11.7 • n=62 Participants	52.8 years STANDARD_DEVIATION 16.8 • n=123 Participants	51.3 years STANDARD_DEVIATION 16.8 • n=53 Participants	57.5 years STANDARD_DEVIATION 9.1 • n=654 Participants	53.5 years STANDARD_DEVIATION 5.4 • n=120 Participants	54.4 years STANDARD_DEVIATION 11.6 • n=18 Participants
Sex: Female, Male Female	3 Participants n=56 Participants	2 Participants n=62 Participants	0 Participants n=123 Participants	0 Participants n=53 Participants	2 Participants n=654 Participants	3 Participants n=120 Participants	10 Participants n=18 Participants
Sex: Female, Male Male	1 Participants n=56 Participants	2 Participants n=62 Participants	5 Participants n=123 Participants	4 Participants n=53 Participants	2 Participants n=654 Participants	1 Participants n=120 Participants	15 Participants n=18 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	0 Participants n=56 Participants	0 Participants n=62 Participants	0 Participants n=123 Participants	0 Participants n=53 Participants	1 Participants n=654 Participants	0 Participants n=120 Participants	1 Participants n=18 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	4 Participants n=56 Participants	4 Participants n=62 Participants	5 Participants n=123 Participants	4 Participants n=53 Participants	3 Participants n=654 Participants	4 Participants n=120 Participants	24 Participants n=18 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	0 Participants n=56 Participants	0 Participants n=62 Participants	0 Participants n=123 Participants	0 Participants n=53 Participants	0 Participants n=654 Participants	0 Participants n=120 Participants	0 Participants n=18 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=56 Participants	0 Participants n=62 Participants	0 Participants n=123 Participants	0 Participants n=53 Participants	0 Participants n=654 Participants	0 Participants n=120 Participants	0 Participants n=18 Participants
Race (NIH/OMB) Asian	0 Participants n=56 Participants	0 Participants n=62 Participants	0 Participants n=123 Participants	0 Participants n=53 Participants	0 Participants n=654 Participants	0 Participants n=120 Participants	0 Participants n=18 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=56 Participants	0 Participants n=62 Participants	0 Participants n=123 Participants	0 Participants n=53 Participants	0 Participants n=654 Participants	0 Participants n=120 Participants	0 Participants n=18 Participants
Race (NIH/OMB) Black or African American	1 Participants n=56 Participants	0 Participants n=62 Participants	2 Participants n=123 Participants	0 Participants n=53 Participants	1 Participants n=654 Participants	0 Participants n=120 Participants	4 Participants n=18 Participants
Race (NIH/OMB) White	3 Participants n=56 Participants	3 Participants n=62 Participants	3 Participants n=123 Participants	4 Participants n=53 Participants	3 Participants n=654 Participants	3 Participants n=120 Participants	19 Participants n=18 Participants
Race (NIH/OMB) More than one race	0 Participants n=56 Participants	1 Participants n=62 Participants	0 Participants n=123 Participants	0 Participants n=53 Participants	0 Participants n=654 Participants	1 Participants n=120 Participants	2 Participants n=18 Participants
Race (NIH/OMB) Unknown or Not Reported	0 Participants n=56 Participants	0 Participants n=62 Participants	0 Participants n=123 Participants	0 Participants n=53 Participants	0 Participants n=654 Participants	0 Participants n=120 Participants	0 Participants n=18 Participants
Region of Enrollment United States	4 Participants n=56 Participants	4 Participants n=62 Participants	5 Participants n=123 Participants	4 Participants n=53 Participants	4 Participants n=654 Participants	4 Participants n=120 Participants	25 Participants n=18 Participants

PRIMARY outcome

Timeframe: Up to 30 days

Population: Of 25 participants randomized, only 20 had usable data for 1kHz and Tonic, 18 had usable data for Burst, and 22 had usable data for Sham. 1 participant's data for the TS512 - Pain Site was not collected, as the participant opted out of testing.

Outcome measures

Outcome measures
Measure	1kHz n=20 Participants Participants in this group received spinal cord stimulation (SCS) delivered as short electrical pulses at a frequency of 1 kHz. This high-frequency stimulation approach does not typically produce a tingling sensation (paresthesia). The stimulation was applied through a participant's implanted SCS system.	Burst n=18 Participants Participants in this group received spinal cord stimulation (SCS) delivered as short sequences ("bursts") of electrical pulses. This stimulation pattern is designed to mimic certain natural neural firing patterns and provide pain relief with reduced paresthesia. The stimulation was applied through a participant's implanted SCS system.	50Hz (Tonic) n=20 Participants Participants in this group received spinal cord stimulation (SCS) using a conventional low-frequency (50 Hz) setting. The stimulation was adjusted to produce a tingling sensation (paresthesia) in the area(s) of pain. The stimulation was applied through a participant's implanted SCS system.	Sham n=22 Participants Participants in this group received spinal cord stimulation (SCS) with settings reduced to minimal, but non-zero, levels. These settings represented only a small fraction of typical stimulation parameters. This approach was intended to mimic active device use, helping to maintain study blinding while minimizing therapeutic effects, and served as the placebo control for the study. The stimulation was applied through a participant's implanted SCS system.
Spinal Cord Stimulation (SCS)-Induced Changes in Temporal Summation (TS) TS512 - Control Site	3.50 score on a scale Interval 0.67 to 23.7	4.67 score on a scale Interval 0.08 to 13.0	1.50 score on a scale Interval 0.0 to 12.4	3.17 score on a scale Interval 0.25 to 16.2
Spinal Cord Stimulation (SCS)-Induced Changes in Temporal Summation (TS) TS256 - Pain Site	3.67 score on a scale Interval 0.75 to 9.5	3.33 score on a scale Interval 1.33 to 5.5	3.67 score on a scale Interval 0.0 to 10.9	3.33 score on a scale Interval 1.33 to 14.3
Spinal Cord Stimulation (SCS)-Induced Changes in Temporal Summation (TS) TS512 - Pain Site	8.33 score on a scale Interval 2.17 to 20.3	5.67 score on a scale Interval 1.33 to 10.0	8.33 score on a scale Interval 2.0 to 12.3	7.67 score on a scale Interval 3.33 to 17.7
Spinal Cord Stimulation (SCS)-Induced Changes in Temporal Summation (TS) TS256 - Control Site	1.67 score on a scale Interval 0.0 to 11.7	3.50 score on a scale Interval 0.0 to 8.75	1.17 score on a scale Interval 0.0 to 12.0	1.50 score on a scale Interval 0.0 to 16.2

OTHER_PRE_SPECIFIED outcome

Timeframe: Up to 30 days

Population: Of 25 participants randomized, only 20 had usable data for Tonic-SCS and Sham-SCS. Per the study protocol, participants who adhered to the protocol and provided data for both the active treatment and sham were included in this analysis. Results are reported per intervention rather than per sequence, as the primary goal was to assess within-subject change from sham to SCS. Reporting by treatment group would blur the per-person change.

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).

Outcome measures

Outcome measures
Measure	1kHz n=20 Participants Participants in this group received spinal cord stimulation (SCS) delivered as short electrical pulses at a frequency of 1 kHz. This high-frequency stimulation approach does not typically produce a tingling sensation (paresthesia). The stimulation was applied through a participant's implanted SCS system.	Burst Participants in this group received spinal cord stimulation (SCS) delivered as short sequences ("bursts") of electrical pulses. This stimulation pattern is designed to mimic certain natural neural firing patterns and provide pain relief with reduced paresthesia. The stimulation was applied through a participant's implanted SCS system.	50Hz (Tonic) Participants in this group received spinal cord stimulation (SCS) using a conventional low-frequency (50 Hz) setting. The stimulation was adjusted to produce a tingling sensation (paresthesia) in the area(s) of pain. The stimulation was applied through a participant's implanted SCS system.	Sham Participants in this group received spinal cord stimulation (SCS) with settings reduced to minimal, but non-zero, levels. These settings represented only a small fraction of typical stimulation parameters. This approach was intended to mimic active device use, helping to maintain study blinding while minimizing therapeutic effects, and served as the placebo control for the study. The stimulation was applied through a participant's implanted SCS system.
SCS-induced Changes in Temporal Summation (TS) - 50Hz (Tonic)-SCS to Sham-SCS Temporal summation with 256mN pressure at primary pain (affected) site	0.283 score on a scale Interval -5.98 to 6.55	—	—	—
SCS-induced Changes in Temporal Summation (TS) - 50Hz (Tonic)-SCS to Sham-SCS Temporal summation with 512mN pressure at primary pain (affected) site	-2.35 score on a scale Interval -8.92 to 4.23	—	—	—
SCS-induced Changes in Temporal Summation (TS) - 50Hz (Tonic)-SCS to Sham-SCS Temporal summation with 256mN pressure at control (unaffected) site	0.758 score on a scale Interval -3.36 to 4.88	—	—	—
SCS-induced Changes in Temporal Summation (TS) - 50Hz (Tonic)-SCS to Sham-SCS Temporal summation with 512mN pressure at control (unaffected) site	1.318 score on a scale Interval -4.29 to 6.92	—	—	—

OTHER_PRE_SPECIFIED outcome

Timeframe: Up to 30 days

Population: Of 25 participants randomized, only 20 had usable data for kHz-SCS and Sham-SCS. Per the study protocol, participants who adhered to the protocol and provided data for both the active treatment and sham were included in this analysis. Results are reported per intervention rather than per sequence, as the primary goal was to assess within-subject change from sham to SCS. Reporting by treatment group would blur the per-person change.

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).

Outcome measures

Outcome measures
Measure	1kHz n=20 Participants Participants in this group received spinal cord stimulation (SCS) delivered as short electrical pulses at a frequency of 1 kHz. This high-frequency stimulation approach does not typically produce a tingling sensation (paresthesia). The stimulation was applied through a participant's implanted SCS system.	Burst Participants in this group received spinal cord stimulation (SCS) delivered as short sequences ("bursts") of electrical pulses. This stimulation pattern is designed to mimic certain natural neural firing patterns and provide pain relief with reduced paresthesia. The stimulation was applied through a participant's implanted SCS system.	50Hz (Tonic) Participants in this group received spinal cord stimulation (SCS) using a conventional low-frequency (50 Hz) setting. The stimulation was adjusted to produce a tingling sensation (paresthesia) in the area(s) of pain. The stimulation was applied through a participant's implanted SCS system.	Sham Participants in this group received spinal cord stimulation (SCS) with settings reduced to minimal, but non-zero, levels. These settings represented only a small fraction of typical stimulation parameters. This approach was intended to mimic active device use, helping to maintain study blinding while minimizing therapeutic effects, and served as the placebo control for the study. The stimulation was applied through a participant's implanted SCS system.
SCS-induced Changes in Temporal Summation (TS) - 1kHz-SCS to Sham-SCS Temporal summation with 256mN pressure at control (unaffected) site	-2.737 score on a scale Interval -6.78 to 1.31	—	—	—
SCS-induced Changes in Temporal Summation (TS) - 1kHz-SCS to Sham-SCS Temporal summation with 512mN pressure at control (unaffected) site	-0.917 score on a scale Interval -6.42 to 4.59	—	—	—
SCS-induced Changes in Temporal Summation (TS) - 1kHz-SCS to Sham-SCS Temporal summation with 256mN pressure at primary pain (affected) site	-4.432 score on a scale Interval -10.59 to 1.72	—	—	—
SCS-induced Changes in Temporal Summation (TS) - 1kHz-SCS to Sham-SCS Temporal summation with 512mN pressure at primary pain (affected) site	-3.90 score on a scale Interval -10.37 to 2.58	—	—	—

OTHER_PRE_SPECIFIED outcome

Timeframe: Up to 30 days

Population: Of 25 participants randomized, only 18 had usable data for burst and sham. Per the study protocol, participants who adhered to the protocol and provided data for both the active treatment and sham were included in this analysis. Results are reported per intervention rather than per sequence, as the primary goal was to assess within-subject change from sham to SCS. Reporting by treatment group would blur the per-person change.

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).

Outcome measures

Outcome measures
Measure	1kHz n=18 Participants Participants in this group received spinal cord stimulation (SCS) delivered as short electrical pulses at a frequency of 1 kHz. This high-frequency stimulation approach does not typically produce a tingling sensation (paresthesia). The stimulation was applied through a participant's implanted SCS system.	Burst Participants in this group received spinal cord stimulation (SCS) delivered as short sequences ("bursts") of electrical pulses. This stimulation pattern is designed to mimic certain natural neural firing patterns and provide pain relief with reduced paresthesia. The stimulation was applied through a participant's implanted SCS system.	50Hz (Tonic) Participants in this group received spinal cord stimulation (SCS) using a conventional low-frequency (50 Hz) setting. The stimulation was adjusted to produce a tingling sensation (paresthesia) in the area(s) of pain. The stimulation was applied through a participant's implanted SCS system.	Sham Participants in this group received spinal cord stimulation (SCS) with settings reduced to minimal, but non-zero, levels. These settings represented only a small fraction of typical stimulation parameters. This approach was intended to mimic active device use, helping to maintain study blinding while minimizing therapeutic effects, and served as the placebo control for the study. The stimulation was applied through a participant's implanted SCS system.
Spinal Cord Stimulation (SCS)-Induced Changes in Temporal Summation (TS) - Burst-SCS to Sham-SCS Temporal summation with 256mN pressure at primary pain (affected) site	-2.304 score on a scale Interval -8.71 to 4.1	—	—	—
Spinal Cord Stimulation (SCS)-Induced Changes in Temporal Summation (TS) - Burst-SCS to Sham-SCS Temporal summation with 512mN pressure at primary pain (affected) site	-5.03 score on a scale Interval -11.76 to 1.71	—	—	—
Spinal Cord Stimulation (SCS)-Induced Changes in Temporal Summation (TS) - Burst-SCS to Sham-SCS Temporal summation with 256mN pressure at control (unaffected) site	0.621 score on a scale Interval -3.59 to 4.83	—	—	—
Spinal Cord Stimulation (SCS)-Induced Changes in Temporal Summation (TS) - Burst-SCS to Sham-SCS Temporal summation with 512mN pressure at control (unaffected) site	-1.780 score on a scale Interval -7.51 to 3.95	—	—	—

Adverse Events

Burst

Serious events: 0 serious events

Other events: 3 other events

Deaths: 0 deaths

Kilohertz (kHz)

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Sham

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Tonic

Serious events: 0 serious events

Other events: 2 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Other adverse events
Measure	Burst n=25 participants at risk Participants in this group received spinal cord stimulation (SCS) delivered as short sequences ("bursts") of electrical pulses. This stimulation pattern is designed to mimic certain natural neural firing patterns and provide pain relief with reduced paresthesia. The stimulation was applied through a participant's implanted SCS system.	Kilohertz (kHz) n=24 participants at risk Participants in this group received spinal cord stimulation (SCS) delivered as short electrical pulses at a frequency of 1 kHz. This high-frequency stimulation approach does not typically produce a tingling sensation (paresthesia). The stimulation was applied through a participant's implanted SCS system.	Sham n=24 participants at risk Participants in this group received spinal cord stimulation (SCS) with settings reduced to minimal, but non-zero, levels. These settings represented only a small fraction of typical stimulation parameters. This approach was intended to mimic active device use, helping to maintain study blinding while minimizing therapeutic effects, and served as the placebo control for the study. The stimulation was applied through a participant's implanted SCS system.	Tonic n=24 participants at risk Participants in this group received spinal cord stimulation (SCS) using a conventional low-frequency (50 Hz) setting. The stimulation was adjusted to produce a tingling sensation (paresthesia) in the area(s) of pain. The stimulation was applied through a participant's implanted SCS system.
Nervous system disorders Pain at implantable pulse generator (IPG) site	4.0% 1/25 • Number of events 1 • 30 days	0.00% 0/24 • 30 days	0.00% 0/24 • 30 days	0.00% 0/24 • 30 days
Nervous system disorders Uncomfortable paresthesia	4.0% 1/25 • Number of events 1 • 30 days	0.00% 0/24 • 30 days	0.00% 0/24 • 30 days	4.2% 1/24 • Number of events 1 • 30 days
Nervous system disorders Abnormal sensation	4.0% 1/25 • Number of events 1 • 30 days	0.00% 0/24 • 30 days	0.00% 0/24 • 30 days	4.2% 1/24 • Number of events 1 • 30 days

Additional Information

Dr. Scott Lempka

University of Michigan

Phone: +1 734-764-2401

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place