Back PainNCT03756012
Evaluation of Clinical Outcomes of Pulse Widths in Spinal Cord Stimulation
A study testing Algovita Spinal Cord Stimulation System in people with Back Pain and Pain, run by Kettering Health Network at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- 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
- 15 participants
- Where
- 1 siteUnited States
- Study dates
- 27 Nov 2018to 2 Oct 2019
- 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
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Multi-Center Evaluation of Clinical Outcomes of Pulse Widths <500 μsec and >1000 μsec During a Temporary Spinal Cord Stimulation Trial
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.
Read the 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.
- 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 |
|---|---|---|
| Low Pulse Width (<500 μsec) | Active comparator | Spinal Cord Stimulation System will be programmed to pulse widths <500 μsec. Receives: Device: Algovita Spinal Cord Stimulation System |
| High Pulse Width (>1000 μsec) | Active comparator | Spinal Cord Stimulation System will be programmed to pulse widths >1000 μsec Receives: Device: Algovita Spinal Cord Stimulation System |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: For 7 days following intervention
Secondary outcomes (7)
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.
Measured: For 7 days following intervention
Distribution of Paesthesia
At end of each arm, subjects will be asked to complete a diagram that shows distribution of paresthesia.
Measured: 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.
Measured: 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
Measured: 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
Measured: For 7 days following intervention
≥ 50% Pain Relief
Number of patients who achieved ≥ 50% pain relief during the trial (from either arm)
Measured: 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.
Measured: For 7 days following intervention
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Nov 2018
- Study start27 Nov 2018
- Primary completion2 Oct 2019
- Study completion2 Oct 2019
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.
- Other trials for Back PainStudies 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
- 15 participants (actual)
Sponsor and investigators
- Lead sponsor
- Kettering Health Network
- Sponsor type
- University, hospital or other
- Collaborators
- Ohio Pain Clinic
- Responsible party
- Principal investigator, Amol Soin, Kettering Health Network
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03756012
- Sponsor's protocol ID
- Expanded Long Pulse
- Status last verified
- Feb 2021
- First submitted
- 26 Nov 2018
- Last updated
- 8 Mar 2021
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 8 Mar 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Multi-Center Evaluation of Clinical Outcomes of Pulse Widths <500 μsec and >1000 μsec During a Temporary Spinal Cord Stimulation Trial
- ClinicalTrials.gov ID
- NCT03756012
- Acronym / sponsor ID
- Expanded Long Pulse
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 15 participants (actual)
- Lead sponsor
- Kettering Health NetworkUniversity, hospital or other
- Collaborators
- Ohio Pain Clinic
- Study start
- 27 Nov 2018 (actual)
- Primary completion
- 2 Oct 2019 (actual)
- Study completion
- 2 Oct 2019 (actual)
- First posted
- 28 Nov 2018 (actual)
- Results
- Posted 8 Mar 2021
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 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.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Low Pulse Width (<500 μsec) | Active comparator | Device: Algovita Spinal Cord Stimulation SystemSpinal Cord Stimulation System will be programmed to pulse widths <500 μsec. |
| High Pulse Width (>1000 μsec) | Active comparator | Device: Algovita Spinal Cord Stimulation SystemSpinal Cord Stimulation System will be programmed to pulse widths >1000 μsec |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (6 listed)
- 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
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 | High Pulse Width (>1000 μsec), Low Pulse Width (<500 μsec) |
Primary outcome
Effect of Pulse Widths on Pain Clinical Outcomes
Time frame: For 7 days following intervention
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.
7 secondary outcomes
Change in Targeted Pain
Time frame: For 7 days following intervention
Distribution of Paesthesia
Time frame: For 7 days following intervention
Research Participant Program Preference
Time frame: For 7 days following intervention
Quality of Pain Relief
Time frame: For 7 days following intervention
Research Participant Pain Relief Satisfaction
Time frame: For 7 days following intervention
≥ 50% Pain Relief
Time frame: For 7 days following intervention
Rate of AEs
Time frame: For 7 days following intervention
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Mar 2021.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- 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.
The record lists no contact. Use the official record to reach the sponsor.
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 Back Pain and Pain, run by Kettering Health Network 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 8 Mar 2021. 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 8 Mar 2021). 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?
Effect of Pulse Widths on Pain Clinical Outcomes (time frame: For 7 days following intervention). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 8 Mar 2021.