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| ID | Type | Description | Link |
|---|---|---|---|
| R01AT010817 | U.S. NIH Grant/Contract | View source |
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| Name | Class |
|---|---|
| National Center for Complementary and Integrative Health (NCCIH) | NIH |
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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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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Burst / kHz / Sham / Tonic | Experimental | 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. |
|
| Burst / Sham / kHz / Tonic | Experimental | 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. |
|
| kHz / Sham / Burst / Tonic | Experimental | 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. |
|
| kHz / Burst / Sham / Tonic | Experimental | 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. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Spinal cord stimulation | Device | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | Up to 30 days |
Not provided
| Measure | Description | Time Frame |
|---|---|---|
| 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). |
Inclusion criteria:
Exclusion criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Scott Lempka, PhD | University of Michigan | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Michigan | Ann Arbor | Michigan | 48109 | United States |
There are no plans to share IPD at this time.
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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.
Recruitment period was between October 2021 - May 2024.
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| ID | Title | Description |
|---|---|---|
| FG000 | 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. |
| FG001 | 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. |
| FG002 | 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. |
| FG003 | 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. |
| FG004 | 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. |
| FG005 | 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. |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
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| ID | Title | Description |
|---|---|---|
| BG000 | 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. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | 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. | 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. | Posted | Median | Inter-Quartile Range | score on a scale | Up to 30 days |
|
30 days
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | 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. |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Pain at implantable pulse generator (IPG) site | Nervous system disorders | Non-systematic Assessment |
Not provided
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr. Scott Lempka | University of Michigan | +1 734-764-2401 | lempka@umich.edu |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | May 24, 2024 | Jun 5, 2025 | Prot_SAP_001.pdf |
| ICF | No | No | Yes | Informed Consent Form | Jun 11, 2023 | Aug 14, 2024 | ICF_000.pdf |
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| ID | Term |
|---|---|
| D059350 | Chronic Pain |
| D055111 | Failed Back Surgery Syndrome |
| D020918 | Complex Regional Pain Syndromes |
| D009437 | Neuralgia |
| ID | Term |
|---|---|
| D010146 | Pain |
| D009461 | Neurologic Manifestations |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
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| ID | Term |
|---|---|
| D062187 | Spinal Cord Stimulation |
| ID | Term |
|---|---|
| D004599 | Electric Stimulation Therapy |
| D013812 | Therapeutics |
| D026741 | Physical Therapy Modalities |
| D012046 | Rehabilitation |
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Subjects will receive each treatment for seven days following one of six randomly-allocated sequences
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There will be two research teams. One team will be unblinded (e.g., clinical care provider/company representative, study coordinator) and will perform stimulator programming/adjustment, and the other team will be blinded (e.g., research personnel) and will perform clinical testing and collect study outcome measures.
| Sham / Burst / kHz / Tonic | Experimental | 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. |
|
| Sham / kHz / Burst / Tonic | Experimental | 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. |
|
| 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). | 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). | Up to 30 days |
| BG001 | 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. |
| BG002 | 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. |
| BG003 | 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. |
| BG004 | 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. |
| BG005 | 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. |
| BG006 | Total | Total of all reporting groups |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Ethnicity (NIH/OMB) | Count of Participants | Participants |
|
| Race (NIH/OMB) | Count of Participants | Participants |
|
| Region of Enrollment | Count of Participants | 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. |
| OG001 | 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. |
| OG002 | 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. |
| OG003 | 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. |
|
|
|
| Other Pre-specified | 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). | 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. | Posted | Least Squares Mean | 95% Confidence Interval | score on a scale | Up to 30 days |
|
|
|
|
| Other Pre-specified | 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). | 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. | Posted | Least Squares Mean | 95% Confidence Interval | score on a scale | Up to 30 days |
|
|
|
|
| Other Pre-specified | 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). | 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. | Posted | Least Squares Mean | 95% Confidence Interval | score on a scale | Up to 30 days |
|
|
|
|
| 0 |
| 25 |
| 0 |
| 25 |
| 3 |
| 25 |
| EG001 | Kilohertz (kHz) | 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. | 0 | 24 | 0 | 24 | 0 | 24 |
| EG002 | 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. | 0 | 24 | 0 | 24 | 0 | 24 |
| EG003 | 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. | 0 | 24 | 0 | 24 | 2 | 24 |
| Uncomfortable paresthesia | Nervous system disorders | Non-systematic Assessment |
|
| Abnormal sensation | Nervous system disorders | Non-systematic Assessment |
|
Not provided
Not provided
| D011183 | Postoperative Complications |
| D010335 | Pathologic Processes |
| D001416 | Back Pain |
| D001342 | Autonomic Nervous System Diseases |
| D009422 | Nervous System Diseases |
| D010523 | Peripheral Nervous System Diseases |
| D009468 | Neuromuscular Diseases |
| Title | Measurements |
|---|---|
|
| Title | Measurements |
|---|---|
|
| Title | Measurements |
|---|---|
|
|
| Temporal summation with 512mN pressure at control (unaffected) site |
|
Temporal summation with 512mN pressure at primary pain (affected) site - Females
| Mixed Models Analysis |
| 0.1225 |
P value was adjusted with Dunnett's method. |
| Mean Difference (Final Values) |
| -8.68 |
| 2-Sided |
| 95 |
| -19.10 |
| 1.73 |
| Superiority |
| Temporal summation with 256mN pressure at control (unaffected) site - Females | Mixed Models Analysis | 0.8881 | P value was adjusted with Dunnett's method. | Mean Difference (Final Values) | -1.41 | 2-Sided | 95 | -8.04 | 5.21 | Superiority |
| Temporal summation with 512mN pressure at control (unaffected) site - Females | Mixed Models Analysis | 0.6374 | P value was adjusted with Dunnett's method. | Mean Difference (Final Values) | -3.58 | 2-Sided | 95 | -12.59 | 5.43 | Superiority |
| Temporal summation with 256mN pressure at primary pain (affected) site - Males | Mixed Models Analysis | 0.2920 | P value was adjusted with Dunnett's method. | Mean Difference (Final Values) | 4.78 | 2-Sided | 95 | -2.68 | 12.24 | Superiority |
| Temporal summation with 512mN pressure at primary pain (affected) site - Males | Mixed Models Analysis | 0.4842 | P value was adjusted with Dunnett's method. | Mean Difference (Final Values) | 3.99 | 2-Sided | 95 | -4.04 | 12.01 | Superiority |
| Temporal summation with 256mN pressure at control (unaffected) site - Males | Mixed Models Analysis | 0.3454 | P value was adjusted with Dunnett's method. | Mean Difference (Final Values) | 2.93 | 2-Sided | 95 | -1.98 | 7.84 | Superiority |
| Temporal summation with 512mN pressure at control (unaffected) site - Males | Mixed Models Analysis | 0.0735 | P value was adjusted with Dunnett's method. | Mean Difference (Final Values) | 6.22 | 2-Sided | 95 | -0.46 | 12.89 | Superiority |
|
| Temporal summation with 512mN pressure at control (unaffected) site |
|
Temporal summation with 512mN pressure at primary pain (affected) site - Females
| Mixed Models Analysis |
| 0.0065 |
P value was adjusted with Dunnett's method. |
| Mean Difference (Final Values) |
| -13.17 |
| 2-Sided |
| 95 |
| -23.13 |
| -3.21 |
| Superiority |
| Temporal summation with 256mN pressure at control (unaffected) site - Females | Mixed Models Analysis | 0.3025 | P value was adjusted with Dunnett's method. | Mean Difference (Final Values) | -4.00 | 2-Sided | 95 | -10.33 | 2.33 | Superiority |
| Temporal summation with 512mN pressure at control (unaffected) site - Females | Mixed Models Analysis | 0.4975 | P value was adjusted with Dunnett's method. | Mean Difference (Final Values) | -4.21 | 2-Sided | 95 | -12.82 | 4.41 | Superiority |
| Temporal summation with 256mN pressure at primary pain (affected) site - Males | Mixed Models Analysis | 0.9697 | P value was adjusted with Dunnett's method. | Mean Difference (Final Values) | -0.87 | 2-Sided | 95 | -8.53 | 6.80 | Superiority |
| Temporal summation with 512mN pressure at primary pain (affected) site - Males | Mixed Models Analysis | P value was adjusted with Dunnett's method. | 0.2805 | P value was adjusted with Dunnett's method. | Mean Difference (Final Values) | 5.38 | 2-Sided | 95 | -2.89 | 13.64 | Superiority |
| Temporal summation with 256mN pressure at control (unaffected) site - Males | Mixed Models Analysis | 0.7921 | P value was adjusted with Dunnett's method. | Mean Difference (Final Values) | -1.47 | 2-Sided | 95 | -6.52 | 3.57 | Superiority |
| Temporal summation with 512mN pressure at control (unaffected) site - Males | Mixed Models Analysis | 0.7156 | P value was adjusted with Dunnett's method. | Mean Difference (Final Values) | 2.37 | 2-Sided | 95 | -4.49 | 9.24 | Superiority |
|
| Temporal summation with 512mN pressure at control (unaffected) site |
|
Temporal summation with 512mN pressure at primary pain (affected) site - Females
| Mixed Models Analysis |
| 0.0132 |
P value was adjusted with Dunnett's method. |
| Mean Difference (Final Values) |
| -12.67 |
| 2-Sided |
| 95 |
| -23.08 |
| -2.25 |
| Superiority |
| Temporal summation with 256mN pressure at control (unaffected) site - Females | Mixed Models Analysis | 0.7098 | P value was adjusted with Dunnett's method. | Mean Difference (Final Values) | -2.32 | 2-Sided | 95 | -8.94 | 4.31 | Superiority |
| Temporal summation with 512mN pressure at control (unaffected) site - Females | Mixed Models Analysis | 0.1907 | P value was adjusted with Dunnett's method. | Mean Difference (Final Values) | -6.68 | 2-Sided | 95 | -15.69 | 2.33 | Superiority |
| Temporal summation with 256mN pressure at primary pain (affected) site - Males | Mixed Models Analysis | 0.9486 | P value was adjusted with Dunnett's method. | Mean Difference (Final Values) | 1.15 | 2-Sided | 95 | -6.76 | 9.06 | Superiority |
| Temporal summation with 512mN pressure at primary pain (affected) site - Males | Mixed Models Analysis | 0.7727 | P value was adjusted with Dunnett's method. | Mean Difference (Final Values) | 2.62 | 2-Sided | 95 | -5.93 | 11.16 | Superiority |
| Temporal summation with 256mN pressure at control (unaffected) site - Males | Mixed Models Analysis | 0.2446 | P value was adjusted with Dunnett's method. | Mean Difference (Final Values) | 3.56 | 2-Sided | 95 | -1.64 | 8.76 | Superiority |
| Temporal summation with 512mN pressure at control (unaffected) site - Males | Mixed Models Analysis | 0.5706 | P value was adjusted with Dunnett's method. | Mean Difference (Final Values) | 3.12 | 2-Sided | 95 | -3.96 | 10.19 | Superiority |