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| ID | Type | Description | Link |
|---|---|---|---|
| U1111-1157-5143 | Other Identifier | World Health Organization - Universal Trial Number |
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The aims of the study are to compare automatic control of spinal cord stimulation with manual control in patients with chronic pain of the trunk and limbs
Subjects will use the Saluda Medical External Trial System to compare automatic control of spinal cord stimulation with manual control in a randomized, blinded, crossover study.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Automatic Control | Experimental | Automatic Control using Saluda Medical External Trial System |
|
| Manual Control | Active Comparator | Manual Control using Saluda Medical External Trial System |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Saluda Medical External Trial System | Device |
| ||
| Saluda Medical External Trial System |
| Measure | Description | Time Frame |
|---|---|---|
| Percentage of Subjects With Improved Pain Relief and/or Stimulation Side Effects During the Automatic Control Arm Relative to the Manual Control Arm | After subjects experience both automatic and manual control after 20 days, subjects are asked to compare pain relief and stimulation side effects between the two arms of the study (blinded) in two separate domains using two 5-point Likert scales. The outcome measure for the primary objective is the percentage of subjects who report improved pain relief with no worsening of stimulation side-effects or improved stimulation side-effects with no loss of pain relief during the automatic control arm relative to the manual control arm. These subjects were considered successful for the primary outcome. | 20 days |
| Measure | Description | Time Frame |
|---|---|---|
| Number of Adverse Events as a Measure of Safety | 20 days | |
| Compare change from baseline of pain scores between automatic and manual control stimulation | Pain scores are obtained from the Visual Analog Scale (VAS) administered at baseline and after each arm of the study |
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Inclusion Criteria:
Patients enrolled in this study must meet the following inclusion criteria:
Exclusion Criteria:
Patients enrolled in this study must not meet the following exclusion criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Michael J Cousins, MD DSc | Pain Management Research Institute and Kolling Institute, University of Sydney at the Royal North Shore Hospital | Principal Investigator |
| Ashwini Sharan, MD | Department of Neurosurgery, Thomas Jefferson University Hospital | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| The Pain Center of Arizona | Phoenix | Arizona | 85027 | United States | ||
| Arizona Pain Specialists |
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| Device |
|
| 20 days |
| Compare change from baseline of quality of life scores, between automatic and manual control stimulation | Quality of life scores are obtained from the Short Form - 36 (SF-36), and EuroQol-5D-5L questionnaires administered at baseline and after each arm of the study | 20 days |
| Compare patient satisfaction with stimulation as measured on a 5-point Likert scale between automatic and manual control stimulation | 20 days |
| Scottsdale |
| Arizona |
| 85258 |
| United States |
| Center for Neurosciences | Tucson | Arizona | 85718 | United States |
| Premier Pain Management | Shrewsbury | New Jersey | 07702 | United States |
| University Pain Management Center | Somerset | New Jersey | 08873 | United States |
| Center for Clinical Research | Winston-Salem | North Carolina | 27103 | United States |
| St Luke's Hospital, Neurosurgical Associates | Bethlehem | Pennsylvania | 18015 | United States |
| Performance Spine & Sports Physicians | East Norriton | Pennsylvania | 19403 | United States |
| Fox Chase Pain Management | Feasterville-Trevose | Pennsylvania | 19053 | United States |
| Thomas Jefferson University | Philadelphia | Pennsylvania | 19107 | United States |
| ID | Term |
|---|---|
| D059350 | Chronic Pain |
| ID | Term |
|---|---|
| D010146 | Pain |
| D009461 | Neurologic Manifestations |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
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