Spinal Cord StimulationNCT03526055
Evaluation of Conventional and Long Pulse Widths During a Temporary Spinal Cord Stimulation Trial
A study testing Algovita Spinal Cord Stimulation System in people with Spinal Cord Stimulation and Pain, Back, run by Amol Soin at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Spinal Cord Stimulation, Pain, Back, Pain
- What is being tested?
- Algovita Spinal Cord Stimulation System
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 10 participants
- Where
- 1 siteUnited States
- Study dates
- 26 Feb 2018to 31 May 2018
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Evaluation of Clinical Outcomes of Pulse Widths <500 µS And >1000 µS During a Temporary Spinal Cord Stimulation Trial
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.
Read the 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.
- Conditions
- Spinal Cord Stimulation, Pain, Back, Pain
- Being tested
- Algovita Spinal Cord Stimulation System
- Medical subject headings
- Back Pain, Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Algovita Spinal Cord Stimulation SystemDevice
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.
| Study group | Role | What they receive |
|---|---|---|
| <500 µS Pulse Width | Active comparator | 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. Receives: Device: Algovita Spinal Cord Stimulation System |
| >1000 µS Pulse Width | Experimental | 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. Receives: Device: Algovita Spinal Cord Stimulation System |
What is being measured
The primary outcome is the main question the study is designed to answer.
Subject Pain Relief
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.
Measured: up to 8 days
Secondary outcomes (6)
Distribution of Paresthesia
- At end of each arm, subjects will be asked to complete a diagram that shows distribution of paresthesia.
Measured: Up to 8 days
Subject Preference
Subjects will be asked to select their favorite program
Measured: Up to 8 days
Quality of Pain Relief
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
Measured: Up to 8 days
Subject Satisfaction
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
Measured: Up to 8 days
Achievement of ≥50% Pain Relief
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.
Measured: Up to 8 days
Rate of AEs
Rate of device-related and/or procedure-related AEs
Measured: From spinal cord stimulation implant through study completion or study exit, Up to 8 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 May 2018
- Study start26 Feb 2018
- Primary completion31 May 2018
- Study completion31 May 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (12)Papers the sponsor has linked to this study.
- Other trials for Spinal Cord StimulationStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Enrolment
- 10 participants (actual)
Sponsor and investigators
- Lead sponsor
- Amol Soin
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Amol Soin, Kettering Health Network
- Investigators
- Amol Soin, MD, MBA, Principal investigator, Ohio Pain Clinic
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03526055
- Sponsor's protocol ID
- Long Pulse
- Status last verified
- Jan 2019
- First submitted
- 6 Mar 2018
- Last updated
- 21 Feb 2019
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No
Publications
American Chronic Pain Association Resource Guide to Chronic Pain Medication and Treatment, 2014 Edition.
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.
PubMed 1831546Wilkinson HA. The Failed Back Surgery Syndrome: Etiology and Therapy, 2nd edition., Philadelphia: Harper & Row, 1991.
Law JD, Lehman RA, Kirsch WM. Reoperation after lumbar intervertebral disc surgery. J Neurosurg. 1978 Feb;48(2):259-63. doi: 10.3171/jns.1978.48.2.0259.
PubMed 146731Lehmann 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.
PubMed 6461073Jobling 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. doi: 10.1007/BF02442479. No abstract available.
PubMed 6966725Davis R, Gray E. Technical factors important to dorsal column stimulation. Appl Neurophysiol. 1981;44(1-3):160-70. doi: 10.1159/000102196.
PubMed 6975071Holsheimer 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.
PubMed 9149258Gould 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
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.
PubMed 20648201Lee 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.
PubMed 21528381Grill 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. doi: 10.1109/10.481985.
PubMed 8682527
Study at a glance
From the registry record, last updated by the sponsor on 21 Feb 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of Clinical Outcomes of Pulse Widths <500 µS And >1000 µS During a Temporary Spinal Cord Stimulation Trial
- ClinicalTrials.gov ID
- NCT03526055
- Acronym / sponsor ID
- Long Pulse
- Conditions
- Spinal Cord Stimulation, Pain, Back, Pain
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 10 participants (actual)
- Lead sponsor
- Amol SoinUniversity, hospital or other
- Study start
- 26 Feb 2018 (actual)
- Primary completion
- 31 May 2018 (actual)
- Study completion
- 31 May 2018 (actual)
- First posted
- 16 May 2018 (actual)
- Results
- Posted 21 Feb 2019
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| <500 µS Pulse Width | Active comparator | Device: Algovita Spinal Cord Stimulation SystemIntervention 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. |
| >1000 µS Pulse Width | Experimental | Device: Algovita Spinal Cord Stimulation SystemIntervention 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (6 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Algovita Spinal Cord Stimulation SystemThe 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. | Device | <500 µS Pulse Width, >1000 µS Pulse Width |
Primary outcome
Subject Pain Relief
Time frame: 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.
6 secondary outcomes
Distribution of Paresthesia
Time frame: Up to 8 days
Subject Preference
Time frame: Up to 8 days
Quality of Pain Relief
Time frame: Up to 8 days
Subject Satisfaction
Time frame: Up to 8 days
Achievement of ≥50% Pain Relief
Time frame: Up to 8 days
Rate of AEs
Time frame: From spinal cord stimulation implant through study completion or study exit, Up to 8 days
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Feb 2019.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- BackgroundAmerican Chronic Pain Association Resource Guide to Chronic Pain Medication and Treatment, 2014 Edition.
- Background: PubMed 1831546North 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.
- BackgroundWilkinson HA. The Failed Back Surgery Syndrome: Etiology and Therapy, 2nd edition., Philadelphia: Harper & Row, 1991.
- Background: PubMed 146731Law JD, Lehman RA, Kirsch WM. Reoperation after lumbar intervertebral disc surgery. J Neurosurg. 1978 Feb;48(2):259-63. doi: 10.3171/jns.1978.48.2.0259.
- Background: PubMed 6461073Lehmann 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.
- Background: PubMed 6966725Jobling 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. doi: 10.1007/BF02442479. No abstract available.
- Background: PubMed 6975071Davis R, Gray E. Technical factors important to dorsal column stimulation. Appl Neurophysiol. 1981;44(1-3):160-70. doi: 10.1159/000102196.
- Background: PubMed 9149258Holsheimer 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.
- BackgroundGould 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
- Background: PubMed 20648201Yearwood 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.
- Background: PubMed 21528381Lee 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.
- Background: PubMed 8682527Grill 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. doi: 10.1109/10.481985.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Amol Soin, MD, MBA principal investigator
Ohio Pain Clinic
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Algovita Spinal Cord Stimulation System in people with Spinal Cord Stimulation and Pain, Back, run by Amol Soin at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 21 Feb 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 21 Feb 2019). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Subject Pain Relief (time frame: up to 8 days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03526055, which also lists 12 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 21 Feb 2019.