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Evaluation of Conventional and Long Pulse Widths During a Temporary Spinal Cord Stimulation Trial

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ClinicalTrials.gov Identifier: NCT03526055
Recruitment Status : Completed
First Posted : May 16, 2018
Results First Posted : February 21, 2019
Last Update Posted : February 21, 2019
Sponsor:
Information provided by (Responsible Party):
Amol Soin, Kettering Health Network

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Crossover Assignment;   Masking: None (Open Label);   Primary Purpose: Other
Conditions Spinal Cord Stimulation
Pain, Back
Pain
Intervention Device: Algovita Spinal Cord Stimulation System
Enrollment 10
Recruitment Details  
Pre-assignment Details  
Arm/Group Title <500 µS Pulse Width First, Then >1000 µS Pulse Width >1000 µS Pulse Width First, Then <500 µS Pulse Width
Hide Arm/Group Description

Intervention includes spinal cord stimulation will be programmed to <500 µS pulse width and patient will undergo an Algovita Spinal Cord Stimulation System trial procedures. Following the trial procedure, the subject’s EPG will be set to the appropriate pulse width, based on the arm assigned, and then programmed to achieve optimal pain relief.

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.

Intervention includes spinal cord stimulation will be programmed to >1000 µS pulse width and patient will undergo an Algovita Spinal Cord Stimulation System trial procedures. Following the trial procedure, the subject’s EPG will be set to the appropriate pulse width, based on the arm assigned, and then programmed to achieve optimal pain relief.

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.

Period Title: Initial Program
Started 5 5
Completed 5 5
Not Completed 0 0
Period Title: Second Program
Started 5 5
Completed 5 5
Not Completed 0 0
Arm/Group Title Entire Study Population
Hide Arm/Group Description Crossover study design, all participant data is collected together.
Overall Number of Baseline Participants 0
Hide Baseline Analysis Population Description
This information was not collected. Although the protocol states that demographic information would be collected at baseline, the sponsor ended up not collecting this information.
Age, Categorical  
Number Analyzed 0 participants
<=18 years
Between 18 and 65 years
>=65 years
Sex: Female, Male  
Number Analyzed 0 participants
Female
Male
Race and Ethnicity Not Collected   [1] 
Number Analyzed 0 participants
[1]
Measure Analysis Population Description: Race and Ethnicity were not collected from any participant.
1.Primary Outcome
Title Subject Pain Relief
Hide Description The study used a pain relief scale (similar to a brief pain inventory). The scale assessed pain relief using a percent relief rating in 10% increments, where a higher number represents greater pain relief than a lower number for the pain scale. A higher number is considered better for pain relief scale. The scale range is from 0%, which is no relief of pain to 100%, which is complete relief of pain. Subjects are asked to rate their pain by marking the box beside the number that best describes their pain in the last 24 hours.
Time Frame up to 8 days
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title <500 µS Pulse Width >1000 µS Pulse Width
Hide Arm/Group Description:

Intervention includes spinal cord stimulation will be programmed to <500 µS pulse width and patient will undergo an Algovita Spinal Cord Stimulation System trial procedures. Following the trial procedure, the subject’s EPG will be set to the appropriate pulse width, based on the arm assigned, and then programmed to achieve optimal pain relief.

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.

Intervention includes spinal cord stimulation will be programmed to >1000 µS pulse width and patient will undergo an Algovita Spinal Cord Stimulation System trial procedures. Following the trial procedure, the subject’s EPG will be set to the appropriate pulse width, based on the arm assigned, and then programmed to achieve optimal pain relief.

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.

Overall Number of Participants Analyzed 10 10
Mean (Full Range)
Unit of Measure: percentage of pain relief
56
(0 to 100)
61
(30 to 90)
2.Secondary Outcome
Title Distribution of Paresthesia
Hide Description 1. At end of each arm, subjects will be asked to complete a diagram that shows distribution of paresthesia.
Time Frame Up to 8 days
Hide Outcome Measure Data
Hide Analysis Population Description
This information was not collected.
Arm/Group Title Entire Study Population
Hide Arm/Group Description:
Crossover study design, all participant data is collected together.
Overall Number of Participants Analyzed 0
No data displayed because Outcome Measure has zero total analyzed.
3.Secondary Outcome
Title Subject Preference
Hide Description Subjects will be asked to select their favorite program
Time Frame Up to 8 days
Hide Outcome Measure Data
Hide Analysis Population Description
1 subject preferred both programs equally.
Arm/Group Title <500 µS Pulse Width >1000 µS Pulse Width
Hide Arm/Group Description:

Intervention includes spinal cord stimulation will be programmed to <500 µS pulse width and patient will undergo an Algovita Spinal Cord Stimulation System trial procedures. Following the trial procedure, the subject’s EPG will be set to the appropriate pulse width, based on the arm assigned, and then programmed to achieve optimal pain relief.

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.

Intervention includes spinal cord stimulation will be programmed to >1000 µS pulse width and patient will undergo an Algovita Spinal Cord Stimulation System trial procedures. Following the trial procedure, the subject’s EPG will be set to the appropriate pulse width, based on the arm assigned, and then programmed to achieve optimal pain relief.

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.

Overall Number of Participants Analyzed 10 10
Measure Type: Count of Participants
Unit of Measure: Participants
4
  40.0%
7
  70.0%
4.Secondary Outcome
Title Quality of Pain Relief
Hide Description Subjects will be asked to rate the quality of the pain relief achieved during the trial (from either arm) using the following scale; Excellent, Very Good, Good, Fair or Poor
Time Frame Up to 8 days
Hide Outcome Measure Data
Hide Analysis Population Description
This information was not collected.
Arm/Group Title Entire Study Population
Hide Arm/Group Description:
Crossover study design, all participant data is collected together.
Overall Number of Participants Analyzed 0
No data displayed because Outcome Measure has zero total analyzed.
5.Secondary Outcome
Title Subject Satisfaction
Hide Description Subjects will be asked to rate their overall satisfaction with the pain relief achieved during the trial (from either arm) using the following scale; Very Satisfied, Satisfied, Neither Satisfied nor Unsatisfied, Unsatisfied or Very Unsatisfied
Time Frame Up to 8 days
Hide Outcome Measure Data
Hide Analysis Population Description
This information was not collected.
Arm/Group Title Entire Study Population
Hide Arm/Group Description:
Crossover study design, all participant data is collected together.
Overall Number of Participants Analyzed 0
No data displayed because Outcome Measure has zero total analyzed.
6.Secondary Outcome
Title Achievement of ≥50% Pain Relief
Hide Description Number of patients who achieved ≥ 50% pain relief during the trial (from either arm). The study used a pain relief scale (similar to a brief pain inventory). The scale assessed pain relief using a percent relief rating in 10% increments, where a higher number represents greater pain relief than a lower number for the pain scale. A higher number is considered better for pain relief scale.
Time Frame Up to 8 days
Hide Outcome Measure Data
Hide Analysis Population Description
10 patients in total, crossover design.
Arm/Group Title <500 µS Pulse Width >1000 µS Pulse Width
Hide Arm/Group Description:

Intervention includes spinal cord stimulation will be programmed to <500 µS pulse width and patient will undergo an Algovita Spinal Cord Stimulation System trial procedures. Following the trial procedure, the subject’s EPG will be set to the appropriate pulse width, based on the arm assigned, and then programmed to achieve optimal pain relief.

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.

Intervention includes spinal cord stimulation will be programmed to >1000 µS pulse width and patient will undergo an Algovita Spinal Cord Stimulation System trial procedures. Following the trial procedure, the subject’s EPG will be set to the appropriate pulse width, based on the arm assigned, and then programmed to achieve optimal pain relief.

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.

Overall Number of Participants Analyzed 10 10
Measure Type: Count of Participants
Unit of Measure: Participants
5
  50.0%
8
  80.0%
7.Secondary Outcome
Title Rate of AEs
Hide Description Rate of device-related and/or procedure-related AEs
Time Frame From spinal cord stimulation implant through study completion or study exit, Up to 8 days
Hide Outcome Measure Data
Hide Analysis Population Description
10 patients total, crossover design
Arm/Group Title Entire Study Population
Hide Arm/Group Description:
Crossover study design, all participant data is collected together.
Overall Number of Participants Analyzed 10
Measure Type: Number
Unit of Measure: participants experienced AE
0
Time Frame Up to 8 days
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title <500 μS Pulse Width >1000 μS Pulse Width
Hide Arm/Group Description Intervention includes spinal cord stimulation will be programmed to <500 µS pulse width and patient will undergo an Algovita Spinal Cord Stimulation System trial procedures. Following the trial procedure, the subject's EPG will be set to the appropriate pulse width, based on the arm assigned, and then programmed to achieve optimal pain relief. Intervention includes spinal cord stimulation will be programmed to >1000 µS pulse width and patient will undergo an Algovita Spinal Cord Stimulation System trial procedures. Following the trial procedure, the subject's EPG will be set to the appropriate pulse width, based on the arm assigned, and then programmed to achieve optimal pain relief.
All-Cause Mortality
<500 μS Pulse Width >1000 μS Pulse Width
Affected / at Risk (%) Affected / at Risk (%)
Total   0/10 (0.00%)   0/10 (0.00%) 
Show Serious Adverse Events Hide Serious Adverse Events
<500 μS Pulse Width >1000 μS Pulse Width
Affected / at Risk (%) Affected / at Risk (%)
Total   0/10 (0.00%)   0/10 (0.00%) 
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 0%
<500 μS Pulse Width >1000 μS Pulse Width
Affected / at Risk (%) Affected / at Risk (%)
Total   0/10 (0.00%)   0/10 (0.00%) 
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
Results Point of Contact
Name/Title: Dr. Amol Soin
Organization: Ohio Pain Clinic
Phone: 937-434-2226
Publications:
American Chronic Pain Association Resource Guide to Chronic Pain Medication and Treatment, 2014 Edition.
Wilkinson HA. The Failed Back Surgery Syndrome: Etiology and Therapy, 2nd edition., Philadelphia: Harper & Row, 1991.
Gould B, Bradley K. Pulse width programming in spinal cord stimulators. Abstract of the American Academy of Pain Medicine 22nd Annual Meeting, 2006 February 22-25. San Diego, CA
Responsible Party: Amol Soin, Kettering Health Network
ClinicalTrials.gov Identifier: NCT03526055     History of Changes
Other Study ID Numbers: Long Pulse
First Submitted: March 6, 2018
First Posted: May 16, 2018
Results First Submitted: November 12, 2018
Results First Posted: February 21, 2019
Last Update Posted: February 21, 2019