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

• Sponsor: Amol Soin (Other)
• Overall Status: Completed
• CT.gov ID: NCT03526055
• Collaborator: (none)
• Enrollment: 10
• Location: 1
• Arms: 2
• Actual Duration (Months): 3.1
• Patients Per Site Per Month: 3.2

Study Details

Study Description

Brief Summary

The purpose of this study is to evaluate the effect of pulse widths <500 µS and >1000 µS on clinical outcomes during a temporary SCS trial.

Condition or Disease	Intervention/Treatment	Phase
Spinal Cord Stimulation; Pain, Back; Pain	Device: Algovita Spinal Cord Stimulation System	N/A

Detailed Description

The proposed study is a prospective, single-center, two arm, randomized, crossover design to be conducted at The Ohio Pain Clinic. The study will enroll up to 15 subjects in order to include up to 10 subjects in the study. 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 Algostim system with percutaneous leads. Each subject will be followed during the trial period of approximately 7 days.

The study will end when the last subject has completed the trial period. exited. The expected enrollment period for this study is approximately three 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.

Study Design

• Study Type: Interventional
• Actual Enrollment: 10 participants
• Allocation: Randomized
• Intervention Model: Crossover Assignment
• Masking: None (Open Label)
• Primary Purpose: Other
• Official Title: Evaluation of Clinical Outcomes of Pulse Widths <500 µS And >1000 µS During a Temporary Spinal Cord Stimulation Trial
• Actual Study Start Date: Feb 26, 2018
• Actual Primary Completion Date: May 31, 2018
• Actual Study Completion Date: May 31, 2018

Arms and Interventions

Arm	Intervention/Treatment
Active Comparator: <500 µS Pulse Width 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.	Device: 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.
Experimental: >1000 µS Pulse Width 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.	Device: 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.

Outcome Measures

Primary Outcome Measures

1. Subject Pain Relief [up to 8 days]

   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.

Secondary Outcome Measures

1. Distribution of Paresthesia [Up to 8 days]

   1. At end of each arm, subjects will be asked to complete a diagram that shows distribution of paresthesia.

2. Subject Preference [Up to 8 days]

   Subjects will be asked to select their favorite program

3. Quality of Pain Relief [Up to 8 days]

   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

4. Subject Satisfaction [Up to 8 days]

   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

5. Achievement of ≥50% Pain Relief [Up to 8 days]

   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.

6. Rate of AEs [From spinal cord stimulation implant through study completion or study exit, Up to 8 days]

   Rate of device-related and/or procedure-related AEs

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years and Older
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

Inclusion Criteria:

• Subject is eligible for SCS therapy according to the Algovita SCS system Indications for Use statement

• Study candidate is undergoing a SCS trial using Nuvectra Algostim system

• Subject signed a valid, Institutional Review Board (IRB)-approved informed consent form.

• Subject is 18 years of age or older when written informed consent is obtained

Exclusion Criteria:

• Subject is contraindicated for an Algovita SCS system

• Subject has a cognitive impairment or exhibits any characteristic, that would limit the study candidate's ability to assess pain relief or complete study assessments

• Subject has a life expectancy of less than 2 years

• Subject is participating in another clinical study that would confound data analysis

• Subject has a coexisting pain condition that might confound pain ratings

• Subject has a significant psychiatric disorder

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Ohio Pain Clinic	Centerville	Ohio	United States	45459

Sponsors and Collaborators

• Amol Soin

Investigators

• Principal Investigator: Amol Soin, MD, MBA, Ohio Pain Clinic

Study Documents (Full-Text)

• Study Protocol - Jan 26, 2018

More Information

Publications

• American Chronic Pain Association Resource Guide to Chronic Pain Medication and Treatment, 2014 Edition.
• Davis R, Gray E. Technical factors important to dorsal column stimulation. Appl Neurophysiol. 1981;44(1-3):160-70.
• 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
• Grill WM Jr, Mortimer JT. The effect of stimulus pulse duration on selectivity of neural stimulation. IEEE Trans Biomed Eng. 1996 Feb;43(2):161-6.
• Holsheimer J. Effectiveness of spinal cord stimulation in the management of chronic pain: analysis of technical drawbacks and solutions. Neurosurgery. 1997 May;40(5):990-6; discussions 996-9. doi: 10.1097/0006123-199705000-00023.
• Jobling DT, Tallis RC, Sedgwick EM, Illis LS. Electronic aspects of spinal-cord stimulation in multiple sclerosis. Med Biol Eng Comput. 1980 Jan;18(1):48-56.
• Law JD, Lehman RA, Kirsch WM. Reoperation after lumbar intervertebral disc surgery. J Neurosurg. 1978 Feb;48(2):259-63.
• Lee D, Hershey B, Bradley K, Yearwood T. Predicted effects of pulse width programming in spinal cord stimulation: a mathematical modeling study. Med Biol Eng Comput. 2011 Jul;49(7):765-74. doi: 10.1007/s11517-011-0780-9. Epub 2011 Apr 29.
• Lehmann TR, LaRocca HS. Repeat lumbar surgery. A review of patients with failure from previous lumbar surgery treated by spinal canal exploration and lumbar spinal fusion. Spine (Phila Pa 1976). 1981 Nov-Dec;6(6):615-9.
• North RB, Campbell JN, James CS, Conover-Walker MK, Wang H, Piantadosi S, Rybock JD, Long DM. Failed back surgery syndrome: 5-year follow-up in 102 patients undergoing repeated operation. Neurosurgery. 1991 May;28(5):685-90; discussion 690-1.
• Wilkinson HA. The Failed Back Surgery Syndrome: Etiology and Therapy, 2nd edition., Philadelphia: Harper & Row, 1991.
• Yearwood TL, Hershey B, Bradley K, Lee D. Pulse width programming in spinal cord stimulation: a clinical study. Pain Physician. 2010 Jul-Aug;13(4):321-35.

• Responsible Party: Amol Soin, Principal Investigator, Kettering Health Network
• ClinicalTrials.gov Identifier: NCT03526055
• Other Study ID Numbers: Long Pulse
• First Posted: May 16, 2018
• Last Update Posted: Feb 21, 2019
• Last Verified: Jan 1, 2019

• Individual Participant Data (IPD) Sharing Statement: No
• Plan to Share IPD: No
• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: Yes
• Additional relevant MeSH terms: Back Pain

Study Results

Participant Flow

Arm/Group Title	<500 µS Pulse Width First, Then >1000 µS Pulse Width	>1000 µS Pulse Width First, Then <500 µS Pulse Width
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: Initial Program
STARTED	5	5
COMPLETED	5	5
NOT COMPLETED	0	0

Baseline Characteristics

Arm/Group Title	Entire Study Population
Arm/Group Description	Crossover study design, all participant data is collected together.
Overall Participants	0
Age () []
<=18 years
Between 18 and 65 years
>=65 years
Sex: Female, Male () []
Female
Male
Race and Ethnicity Not Collected () []

Outcome Measures

1. Primary Outcome

Title	Subject Pain Relief
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

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	<500 µS Pulse Width	>1000 µS Pulse Width
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.
Measure Participants	10	10
Mean (Full Range) [percentage of pain relief]	56	61

2. Secondary Outcome

Title	Distribution of Paresthesia
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

Outcome Measure Data

Analysis Population Description

This information was not collected.

Arm/Group Title	Entire Study Population
Arm/Group Description	Crossover study design, all participant data is collected together.
Measure Participants	0

3. Secondary Outcome

Title	Subject Preference
Description	Subjects will be asked to select their favorite program
Time Frame	Up to 8 days

Outcome Measure Data

Analysis Population Description

1 subject preferred both programs equally.

Arm/Group Title	<500 µS Pulse Width	>1000 µS Pulse Width
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.
Measure Participants	10	10
Count of Participants [Participants]	4 Infinity	7 NaN

4. Secondary Outcome

Title	Quality of Pain Relief
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

Outcome Measure Data

Analysis Population Description

This information was not collected.

Arm/Group Title	Entire Study Population
Arm/Group Description	Crossover study design, all participant data is collected together.
Measure Participants	0

5. Secondary Outcome

Title	Subject Satisfaction
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

Outcome Measure Data

Analysis Population Description

This information was not collected.

Arm/Group Title	Entire Study Population
Arm/Group Description	Crossover study design, all participant data is collected together.
Measure Participants	0

6. Secondary Outcome

Title	Achievement of ≥50% Pain Relief
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

Outcome Measure Data

Analysis Population Description

10 patients in total, crossover design.

Arm/Group Title	<500 µS Pulse Width	>1000 µS Pulse Width
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.
Measure Participants	10	10
Count of Participants [Participants]	5 Infinity	8 NaN

7. Secondary Outcome

Title	Rate of AEs
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

Outcome Measure Data

Analysis Population Description

10 patients total, crossover design

Arm/Group Title	Entire Study Population
Arm/Group Description	Crossover study design, all participant data is collected together.
Measure Participants	10
Number [participants experienced AE]	0 NaN

Adverse Events

Time Frame	Up to 8 days
Arm/Group Title	<500 μS Pulse Width		>1000 μS Pulse Width
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 (%)	# Events	Affected / at Risk (%)	# Events
Total	0/10 (0%)		0/10 (0%)
Serious Adverse Events
	<500 μS Pulse Width		>1000 μS Pulse Width
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/10 (0%)		0/10 (0%)
Other (Not Including Serious) Adverse Events
	<500 μS Pulse Width		>1000 μS Pulse Width
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/10 (0%)		0/10 (0%)

Limitations/Caveats

[Not Specified]

More Information

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.