Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Class |
|---|---|
| Ohio Pain Clinic | OTHER |
Not provided
Not provided
Not provided
The purpose of this study is to evaluate the effect of pulse widths <500 μsec and >1000 μsec on clinical outcomes during a temporary SCS trial.
The proposed study is a prospective, multi-center, two-arm, randomized, crossover design to be conducted at up to 10 sites. The study will enroll up to 100 subjects in order to include up to 10 subjects in the study per site. Subjects selected to participate in the trial have back and/or leg pain, have been evaluated as a candidate for SCS and have agreed to undergo a temporary SCS trial using the Algovita® system with percutaneous leads. Each subject will be followed during the trial period of approximately 7+/-2 days. The study will end when the last subject has completed the trial period and exited. The expected enrollment period for this study is approximately six months. After exit from the clinical study, subjects will continue to be followed by their physician per usual care. All device and procedure-related AEs will be collected and reported per the study protocol.
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Low Pulse Width (<500 μsec) | Active Comparator | Spinal Cord Stimulation System will be programmed to pulse widths <500 μsec. |
|
| High Pulse Width (>1000 μsec) | Active Comparator | Spinal Cord Stimulation System will be programmed to pulse widths >1000 μsec |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Algovita Spinal Cord Stimulation System | Device | The Algovita™ SCS system is indicated as an aid in the management of chronic intractable pain of the trunk and/or limbs, including unilateral or bilateral pain associated with failed back surgery syndrome, intractable low back pain and leg pain. |
| Measure | Description | Time Frame |
|---|---|---|
| Effect of Pulse Widths on Pain Clinical Outcomes | To evaluate the effect of conventional pulse widths <500 μsec and pulse widths >1000 μsec on clinical outcomes during temporary trial as measured by patient defined pain maps. | For 7 days following intervention |
| Measure | Description | Time Frame |
|---|---|---|
| Change in Targeted Pain | To evaluate the effect of conventional pulse widths <500μsecand pulse widths and >1000μsecon clinical outcomes during temporary trial as measured by the number of participants that reported significant change in targeted pain compared to baseline using the NRS at the end of the trial period. | For 7 days following intervention |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| The Ohio Pain Clinic | Centerville | Ohio | 45458 | United States |
Not provided
Not provided
Not provided
Not provided
Not provided
patients received both doses
Not provided
Not provided
| ID | Title | Description |
|---|---|---|
| FG000 | Total Patient Population | This was a case series and all patients received both algorithms; pulse widths <500 µsec and >1000 µsec during a temporary SCS trial with Algovita Trial System. Study ended early and results are only available for total population. |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
Not provided
Not provided
| ID | Title | Description |
|---|---|---|
| BG000 | Total Patient Population | This was a case series and all patients received both algorithms; pulse widths <500 µsec and >1000 µsec during a temporary SCS trial with Algovita Trial System. Study ended early and results are only available for total population. Algovita Spinal Cord Stimulation System: The Algovita™ SCS system is indicated as an aid in the management of chronic intractable pain of the trunk and/or limbs, including unilateral or bilateral pain associated with failed back surgery syndrome, intractable low back pain and leg pain. |
| 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 | Effect of Pulse Widths on Pain Clinical Outcomes | To evaluate the effect of conventional pulse widths <500 μsec and pulse widths >1000 μsec on clinical outcomes during temporary trial as measured by patient defined pain maps. | Full statistical analysis did not occur due to premature termination of study. Results were not reported per group, but rather in total since patients received both intervention arms (both pulse widths). | Posted | Count of Participants | Participants | For 7 days following intervention |
|
up to 10 days post-implant
Adverse Events were not collected.
Not provided
| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Total Patient Population | This was a case series and all patients received both algorithms; pulse widths <500 µsec and >1000 µsec during a temporary SCS trial with Algovita Trial System. Study ended early and results are only available for total population. Algovita Spinal Cord Stimulation System: The Algovita™ SCS system is indicated as an aid in the management of chronic intractable pain of the trunk and/or limbs, including unilateral or bilateral pain associated with failed back surgery syndrome, intractable low back pain and leg pain. Adverse Events were not collected. Study was ended prematurely and results were only provided for total population instead of separate arms since subjects received both interventions. |
Not provided
Not provided
Not provided
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr. Amol Soin | Ohio Pain Clinic | 937-434-2226 | drsoin@ohiopainclinic.com |
Not provided
| 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 | Mar 9, 2014 | Dec 8, 2020 | Prot_SAP_000.pdf |
Not provided
Not provided
Not provided
| ID | Term |
|---|---|
| D001416 | Back Pain |
| D010146 | Pain |
| ID | Term |
|---|---|
| D009461 | Neurologic Manifestations |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
|
| Distribution of Paesthesia | At end of each arm, subjects will be asked to complete a diagram that shows distribution of paresthesia. | For 7 days following intervention |
| Research Participant Program Preference | At the end of the trial period, subjects will be asked to select their favorite program. | For 7 days following intervention |
| Quality of Pain Relief | At the end of the trial period, subjects will be asked to rate the quality of the pain relief achieved during the trial (from either arm) using the following ordinal scale; Excellent, Very Good, Good, Fair or Poor | For 7 days following intervention |
| Research Participant Pain Relief Satisfaction | At the end of the trial period, subjects will be asked to rate their overall satisfaction with the pain relief achieved during the trial (from either arm) using the following ordinal scale; Very Satisfied, Satisfied, Neither Satisfied nor Unsatisfied, Unsatisfied or Very Unsatisfied | For 7 days following intervention |
| ≥ 50% Pain Relief | Number of patients who achieved ≥ 50% pain relief during the trial (from either arm) | For 7 days following intervention |
| Rate of AEs | Rate of device-related and/or procedure-related AEs from SCS implant through study completion or study exit. | For 7 days following intervention |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Race and Ethnicity Not Collected | Race and Ethnicity were not collected from any participant. | Count of Participants | Participants |
|
|
|
| Secondary | Change in Targeted Pain | To evaluate the effect of conventional pulse widths <500μsecand pulse widths and >1000μsecon clinical outcomes during temporary trial as measured by the number of participants that reported significant change in targeted pain compared to baseline using the NRS at the end of the trial period. | Full statistical analysis did not occur due to premature termination of study. Results were not reported per group, but rather in total since patients received both intervention arms (both pulse widths). | Posted | Count of Participants | Participants | For 7 days following intervention |
|
|
|
| Secondary | Distribution of Paesthesia | At end of each arm, subjects will be asked to complete a diagram that shows distribution of paresthesia. | Full statistical analysis did not occur due to premature termination of study. Results were not reported per group, but rather in total since patients received both intervention arms (both pulse widths). | Posted | Count of Participants | Participants | For 7 days following intervention |
|
|
|
| Secondary | Research Participant Program Preference | At the end of the trial period, subjects will be asked to select their favorite program. | Full statistical analysis did not occur due to premature termination of study. Results were not reported per group, but rather in total since patients received both intervention arms (both pulse widths). | Posted | Count of Participants | Participants | For 7 days following intervention |
|
|
|
| Secondary | Quality of Pain Relief | At the end of the trial period, subjects will be asked to rate the quality of the pain relief achieved during the trial (from either arm) using the following ordinal scale; Excellent, Very Good, Good, Fair or Poor | Full statistical analysis did not occur due to premature termination of study. Results were not reported per group, but rather in total since patients received both intervention arms (both pulse widths). | Posted | Count of Participants | Participants | For 7 days following intervention |
|
|
|
| Secondary | Research Participant Pain Relief Satisfaction | At the end of the trial period, subjects will be asked to rate their overall satisfaction with the pain relief achieved during the trial (from either arm) using the following ordinal scale; Very Satisfied, Satisfied, Neither Satisfied nor Unsatisfied, Unsatisfied or Very Unsatisfied | Full statistical analysis did not occur due to premature termination of study. Results were not reported per group, but rather in total since patients received both intervention arms (both pulse widths). | Posted | Count of Participants | Participants | For 7 days following intervention |
|
|
|
| Secondary | ≥ 50% Pain Relief | Number of patients who achieved ≥ 50% pain relief during the trial (from either arm) | Full statistical analysis did not occur due to premature termination of study. Results were not reported per group, but rather in total since patients received both intervention arms (both pulse widths). | Posted | Count of Participants | Participants | For 7 days following intervention |
|
|
|
| Secondary | Rate of AEs | Rate of device-related and/or procedure-related AEs from SCS implant through study completion or study exit. | was not collected | Posted | For 7 days following intervention |
|
|
| 0 |
| 0 |
| 0 |
| 0 |
| 0 |
| 0 |
Not provided
Not provided
| Fair |
|
| Poor |
|
| Unsatisfied |
|
| Very Unsatisfied |
|