Evaluation of Clinical Outcomes of Pulse Widths in Spinal Cord Stimulation
Primary Purpose
Back Pain, Pain
Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Algovita Spinal Cord Stimulation System
Sponsored by
About this trial
This is an interventional other trial for Back Pain
Eligibility Criteria
Inclusion Criteria:
- be eligible for SCS therapy according to the Algovita® SCS system Indications for Use statement
- be undergoing a SCS trial using Algovita® SCS system
- sign a valid, Institutional Review Board (IRB)-approved informed consent form.
- be 18 years of age or older when written informed consent is obtained
Exclusion Criteria:
- be contraindicated for an Algovita® SCS system
- have a cognitive impairment or exhibits any characteristic, that would limit the study candidate's ability to assess pain relief or complete study assessments
- have a life expectancy of less than 2 years
- be participating in another clinical study that would confound data analysis
- have a coexisting pain condition that might confound pain ratings
- have a significant psychiatric disorder
Sites / Locations
- The Ohio Pain Clinic
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Active Comparator
Arm Label
Low Pulse Width (<500 μsec)
High Pulse Width (>1000 μsec)
Arm Description
Spinal Cord Stimulation System will be programmed to pulse widths <500 μsec.
Spinal Cord Stimulation System will be programmed to pulse widths >1000 μsec
Outcomes
Primary Outcome Measures
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.
Secondary Outcome Measures
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.
Distribution of Paesthesia
At end of each arm, subjects will be asked to complete a diagram that shows distribution of paresthesia.
Research Participant Program Preference
At the end of the trial period, subjects will be asked to select their favorite program.
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
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
≥ 50% Pain Relief
Number of patients who achieved ≥ 50% pain relief during the trial (from either arm)
Rate of AEs
Rate of device-related and/or procedure-related AEs from SCS implant through study completion or study exit.
Full Information
NCT ID
NCT03756012
First Posted
November 26, 2018
Last Updated
February 15, 2021
Sponsor
Kettering Health Network
Collaborators
Ohio Pain Clinic
1. Study Identification
Unique Protocol Identification Number
NCT03756012
Brief Title
Evaluation of Clinical Outcomes of Pulse Widths in Spinal Cord Stimulation
Official Title
Multi-Center Evaluation of Clinical Outcomes of Pulse Widths <500 μsec and >1000 μsec During a Temporary Spinal Cord Stimulation Trial
Study Type
Interventional
2. Study Status
Record Verification Date
February 2021
Overall Recruitment Status
Completed
Study Start Date
November 27, 2018 (Actual)
Primary Completion Date
October 2, 2019 (Actual)
Study Completion Date
October 2, 2019 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Kettering Health Network
Collaborators
Ohio Pain Clinic
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
Yes
Product Manufactured in and Exported from the U.S.
No
Data Monitoring Committee
No
5. Study Description
Brief Summary
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.
Detailed Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Back Pain, Pain
7. Study Design
Primary Purpose
Other
Study Phase
Not Applicable
Interventional Study Model
Crossover Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
15 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Low Pulse Width (<500 μsec)
Arm Type
Active Comparator
Arm Description
Spinal Cord Stimulation System will be programmed to pulse widths <500 μsec.
Arm Title
High Pulse Width (>1000 μsec)
Arm Type
Active Comparator
Arm Description
Spinal Cord Stimulation System will be programmed to pulse widths >1000 μsec
Intervention Type
Device
Intervention Name(s)
Algovita Spinal Cord Stimulation System
Intervention Description
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.
Primary Outcome Measure Information:
Title
Effect of Pulse Widths on Pain Clinical Outcomes
Description
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.
Time Frame
For 7 days following intervention
Secondary Outcome Measure Information:
Title
Change in Targeted Pain
Description
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.
Time Frame
For 7 days following intervention
Title
Distribution of Paesthesia
Description
At end of each arm, subjects will be asked to complete a diagram that shows distribution of paresthesia.
Time Frame
For 7 days following intervention
Title
Research Participant Program Preference
Description
At the end of the trial period, subjects will be asked to select their favorite program.
Time Frame
For 7 days following intervention
Title
Quality of Pain Relief
Description
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
Time Frame
For 7 days following intervention
Title
Research Participant Pain Relief Satisfaction
Description
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
Time Frame
For 7 days following intervention
Title
≥ 50% Pain Relief
Description
Number of patients who achieved ≥ 50% pain relief during the trial (from either arm)
Time Frame
For 7 days following intervention
Title
Rate of AEs
Description
Rate of device-related and/or procedure-related AEs from SCS implant through study completion or study exit.
Time Frame
For 7 days following intervention
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
be eligible for SCS therapy according to the Algovita® SCS system Indications for Use statement
be undergoing a SCS trial using Algovita® SCS system
sign a valid, Institutional Review Board (IRB)-approved informed consent form.
be 18 years of age or older when written informed consent is obtained
Exclusion Criteria:
be contraindicated for an Algovita® SCS system
have a cognitive impairment or exhibits any characteristic, that would limit the study candidate's ability to assess pain relief or complete study assessments
have a life expectancy of less than 2 years
be participating in another clinical study that would confound data analysis
have a coexisting pain condition that might confound pain ratings
have a significant psychiatric disorder
Facility Information:
Facility Name
The Ohio Pain Clinic
City
Centerville
State/Province
Ohio
ZIP/Postal Code
45458
Country
United States
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
Evaluation of Clinical Outcomes of Pulse Widths in Spinal Cord Stimulation
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