Chronic PainNCT03622866
Algovita Spinal Cord Stimulation System Hi-Fi Study
A study testing Ultra-high pulse width stimulation and Traditional pulse width stimulation in people with Chronic Pain, run by Nuvectra at 10 sites in United States.
Trial summary
The objective of this study is to obtain post-market clinical outcome data for the Algovita SCS System when used on-label, according to the applicable directions for use, using high fidelity tonic stimulation at either ultra-high pulse width or traditional pulse width for the treatment of persistent or recurrent back… Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Chronic Pain
- What is being tested?
- Ultra-high pulse width stimulation and Traditional pulse width stimulation
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- 10 sitesUnited States
- Study dates
- 2 Nov 2018to 27 Apr 2020
- Phase
- Interventional
- Are there results?
- None posted in the registry
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 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients with FBSS defined as persistent or recurrent back and/or leg pain despite one or more anatomically successful back surgeries for the same original pain.
- Age 18-75 years old at consent.
- Targeted pain intensity of ≥ 5 out of 10 on the Baseline visit NRS.
- ODI score of 41-80 out of 100 at the Baseline visit.
- Appropriate candidate for the surgical procedure and Algovita SCS therapy based on the clinical judgment of the investigator and the Algovita Instructions for Provider (IFP) in the Nuvectra product manuals.
- On stable pain medications for at least 28 days prior to consent. Stable is defined as no new or discontinued pain medications and no changes to total daily dose of any pain medications.
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- Willing and capable of providing informed consent.
- Willing and able of complying with the study-related requirements, procedures, and visits.
- Speaks English as a primary language (as the Algovita patient manuals are only currently available in English).
- Has adequate cognitive ability to use the subject devices (e.g., PPC, PoP), as determined by the investigator.
Who cannot join
- Has a medical/psychological/psychiatric condition/disorder that could interfere with study procedures as determined by the investigator.
- Has a coexisting pain condition that might confound pain ratings, as determined by the investigator.
- Has a condition currently requiring or likely to require the use of MRI or diathermy.
- Has an existing drug pump, SCS System, or other active implantable device.
- Has any prior SCS experience.
- Pregnant or planning to become (if female and sexually active, subject must be using a reliable form of birth control, be surgically sterile, or be at least 2 years postmenopausal).
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- For subjects with diabetes, HbA1c ≥ 8.5% as measured at the Baseline visit (or within the 3 months prior to the Baseline visit).
- Participating in another clinical trial that could affect the outcomes or requirements of this study as determined by the investigator.
- Involved in an injury claim under current litigation or have a pending or approved workers compensation claim.
Trial locations and contacts
10 sites in 1 country.
10 sites in 1 country
United States10 sites
Brigham & Women's Hospital
Chestnut Hill, Massachusetts, 02467
Adena Spine Center
Chillicothe, Ohio, 45601
Cleveland Clinic Foundation
Cleveland, Ohio, 44195
Spinal Diagnostics & Pain Management
Colorado Springs, Colorado, 80919
Newport Beach Headache & Pain
Newport Beach, California, 92660
Mid-America PolyClinic & Interventional Pain Management Specialists
Overland Park, Kansas, 66210
Comprehensive Spine Center at Rhode Island Hospital
Providence, Rhode Island, 02903
Summit Pain Alliance
Santa Rosa, California, 95401
WK River Cities Clinical Research Center
Shreveport, Louisiana, 71105
Pain Institute of Southern Arizona
Tucson, Arizona, 85712
About this study
Official title: Clinical Trial Comparing Ultra-High Versus Traditional Pulse Widths Using the ALGOVITA® SCS System High Fidelity Stimulation in the Treatment of Persistent or Recurrent Back and/or Leg Pain Following Spinal Surgery
The objective of this study is to obtain post-market clinical outcome data for the Algovita SCS System when used on-label, according to the applicable directions for use, using high fidelity tonic stimulation at either ultra-high pulse width or traditional pulse width for the treatment of persistent or recurrent back and/or leg pain following spinal surgery.
- Conditions
- Chronic Pain
- Being tested
- Ultra-high pulse width stimulation, Traditional pulse width stimulation
- Medical subject headings
- Chronic Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Ultra-high pulse width stimulationDevice
Algovita Spinal Cord Stimulation System with associated components
Traditional pulse width stimulationDevice
Algovita Spinal Cord Stimulation System with associated components
| Study group | Role | What they receive |
|---|---|---|
| Ultra-high pulse width | Active comparator | Ultra-high pulse width stimulation using the Algovita System Receives: Device: Ultra-high pulse width stimulation |
| Traditional pulse width | Active comparator | Traditional pulse width stimulation using the Algovita System Receives: Device: Traditional pulse width stimulation |
What is being measured
The primary outcome is the main question the study is designed to answer.
Effectiveness of targeted pain reduction compared to baseline in each treatment arm
The percentage of participants who experience at least a 50 percent reduction in targeted pain from baseline, as assessed by Numeric Rating Scale (NRS). The Numeric Rating Scale (NRS) will range from 0 to 10 with a higher score indicating a higher level of pain.
Effectiveness will be compared both descriptively and statistically between the two randomized treatment groups using crossover analysis methods.
Measured: Week 25
Rate of serious study-related adverse events (AEs) in each treatment arm
The rate of serious study-related AEs. Study-related AEs are defined as any device, procedure and therapy/stimulation-related AEs.
Measured: From Permanent Implant through Week 25
Secondary outcomes (13)
Effectiveness of targeted pain reduction compared to baseline in each treatment arm
The percentage of participants who experience at least a 50 percent reduction in targeted pain as assessed by Numeric Rating Scale (NRS). The Numeric Rating Scale (NRS) will range from 0 to 10 with a higher score indicating a higher level of pain.
Measured: Week 12 and Months 12, 18 and 24
Effectiveness of back and/or leg pain reduction compared to baseline in each treatment arm
The percentage of participants who experience at least a 50 percent reduction in back and/or leg pain as assessed by Numeric Rating Scale (NRS). The Numeric Rating Scale (NRS) will range from 0 to 10 with a higher score indicating a higher level of pain.
Measured: Weeks 12 and 25, and Months 12, 18 and 24
Effectiveness of targeted, back and/or leg pain reduction compared to baseline in each treatment arm
The percentage of participants who experience at least a 50 percent reduction in targeted, back and/or leg pain as assessed by a Visual Analog Scale (VAS). The Visual Analog Scale (VAS) will range from 0 mm (no pain) to 100 mm (worst pain imaginable). A higher score indicates a higher level of pain.
Measured: Weeks 12 and 25, and Months 12, 18 and 24
Change in targeted, back and/or leg pain compared to baseline in each treatment arm
The mean change and percent change from baseline in targeted, back and/or leg pain as assessed by a Numeric Rating Scale (NRS). The Numeric Rating Scale (NRS) will range from 0 to 10 with a higher score indicating a higher level of pain.
Measured: Weeks 12 and 25, and Months 12, 18 and 24
Change in targeted, back and/or leg pain compared to baseline in each treatment arm
The mean change and percent change from baseline in targeted, back and/or leg pain as assessed by a Visual Analog Scale (VAS). The Visual Analog Scale (VAS) will range from 0 mm (no pain) to 100 mm (worst pain imaginable). A higher score indicates a higher level of pain.
Measured: Weeks 12 and 25, and Months 12, 18 and 24
Clinician Global Impression of Change score in each treatment arm
The Investigator's assessment of change in the overall status of the participant using the standard Clinician Global Impression of Change ranging from 1 (very much improved) to 7 (very much worse).
Measured: Weeks 12 and 25, and Months 12, 18 and 24
Change in disability compared to baseline in each treatment arm
The change from baseline in disability as measured by the Oswestry Disability Index. The Oswestry Disability Index is scored between 0 and 100 with higher scores indicating a greater disability.
Measured: Weeks 12 and 25, and Months 12, 18 and 24
Change in quality of life compared to baseline in each treatment arm
The change from baseline in quality of life as measured by the EQ-5D-5L, a standardized measure of health status.
Measured: Weeks 12 and 25, and Months 12, 18 and 24
Change in patient activity per the Pain Disability Index score in each treatment arm
The change from baseline in patient activity as measured by the Pain Disability Index score. The Pain Disability Index is a self-report asking participants to rate how much pain interferes in seven areas of life activity using a 0 (no disability) to 10 (total disability) numeric rating scale.
Measured: Weeks 12 and 25, and Months 12, 18 and 24
Patient Global Impression of Change score in each treatment arm
The participant's assessment of change in their overall status using the standard Patient Global Impression of Change ranging from 1 (very much improved) to 7 (very much worse).
Measured: Weeks 12 and 25, and Months 12, 18 and 24
Participant satisfaction per the subject satisfaction survey outcome in each treatment arm
Participant satisfaction using a subject satisfaction survey (5 point Likert scale format) ranging from very satisfied to very dissatisfied.
Measured: Weeks 12 and 25, and Months 12, 18 and 24
Evaluation of trial success rates
The percentage of participants that have a successful trial phase, defined as at least a 50 percent reduction in targeted pain compared to baseline.
Measured: From Trial Implant to End of Trail
Rate of surgical re-intervention of the SCS system
Rate of surgical re-intervention of the SCS system for participants with a permanent implant.
Measured: From Permanent Implant through Month 24
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Aug 2018
- Study start2 Nov 2018
- Primary completion27 Apr 2020
- Study completion27 Apr 2020
Why it stopped: Sponsor bankruptcy
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Chronic 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Model description
- During the Treatment Phase of the study, all subjects will receive both treatments under a crossover design. Subjects will undergo 12 weeks of treatment in each group with a 1-week washout between groups.
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 20 participants (actual)
Sponsor and investigators
- Lead sponsor
- Nuvectra
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Bright Research Partners
- Responsible party
- Sponsor
- Investigators
- Ben Tranchina, Study director, Nuvectra
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03622866
- Sponsor's protocol ID
- CLRE 1092
- Status last verified
- Mar 2021
- First submitted
- 26 Jul 2018
- Last updated
- 11 Mar 2021
- Results posted
- No
- 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 11 Mar 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Clinical Trial Comparing Ultra-High Versus Traditional Pulse Widths Using the ALGOVITA® SCS System High Fidelity Stimulation in the Treatment of Persistent or Recurrent Back and/or Leg Pain Following Spinal Surgery
- ClinicalTrials.gov ID
- NCT03622866
- Acronym / sponsor ID
- CLRE 1092
- Conditions
- Chronic Pain
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Sponsor bankruptcy
- Enrolment
- 20 participants (actual)
- Lead sponsor
- NuvectraIndustry (pharma, biotech, devices)
- Collaborators
- Bright Research Partners
- Study start
- 2 Nov 2018 (actual)
- Primary completion
- 27 Apr 2020 (actual)
- Study completion
- 27 Apr 2020 (actual)
- First posted
- 9 Aug 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The objective of this study is to obtain post-market clinical outcome data for the Algovita SCS System when used on-label, according to the applicable directions for use, using high fidelity tonic stimulation at either ultra-high pulse width or traditional pulse width for the treatment of persistent or recurrent back and/or leg pain following spinal surgery.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 2
- Model description
- During the Treatment Phase of the study, all subjects will receive both treatments under a crossover design. Subjects will undergo 12 weeks of treatment in each group with a 1-week washout between groups.
| Arm | Type | Receives |
|---|---|---|
| Ultra-high pulse width | Active comparator | Device: Ultra-high pulse width stimulationUltra-high pulse width stimulation using the Algovita System |
| Traditional pulse width | Active comparator | Device: Traditional pulse width stimulationTraditional pulse width stimulation using the Algovita System |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (10 listed)
- Patients with FBSS defined as persistent or recurrent back and/or leg pain despite one or more anatomically successful back surgeries for the same original pain.
- Age 18-75 years old at consent.
- Targeted pain intensity of ≥ 5 out of 10 on the Baseline visit NRS.
- ODI score of 41-80 out of 100 at the Baseline visit.
- Appropriate candidate for the surgical procedure and Algovita SCS therapy based on the clinical judgment of the investigator and the Algovita Instructions for Provider (IFP) in the Nuvectra product manuals.
Key exclusion criteria (9 listed)
- Has a medical/psychological/psychiatric condition/disorder that could interfere with study procedures as determined by the investigator.
- Has a coexisting pain condition that might confound pain ratings, as determined by the investigator.
- Has a condition currently requiring or likely to require the use of MRI or diathermy.
- Has an existing drug pump, SCS System, or other active implantable device.
- Has any prior SCS experience.
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 |
|---|---|---|
| Ultra-high pulse width stimulationAlgovita Spinal Cord Stimulation System with associated components | Device | Ultra-high pulse width |
| Traditional pulse width stimulationAlgovita Spinal Cord Stimulation System with associated components | Device | Traditional pulse width |
Primary outcome
Effectiveness of targeted pain reduction compared to baseline in each treatment arm
Time frame: Week 25
The percentage of participants who experience at least a 50 percent reduction in targeted pain from baseline, as assessed by Numeric Rating Scale (NRS). The Numeric Rating Scale (NRS) will range from 0 to 10 with a higher score indicating a higher level of pain. Effectiveness will be compared both descriptively and statistically between the two randomized treatment groups using crossover analysis methods.
Rate of serious study-related adverse events (AEs) in each treatment arm
Time frame: From Permanent Implant through Week 25
The rate of serious study-related AEs. Study-related AEs are defined as any device, procedure and therapy/stimulation-related AEs.
13 secondary outcomes
Effectiveness of targeted pain reduction compared to baseline in each treatment arm
Time frame: Week 12 and Months 12, 18 and 24
Effectiveness of back and/or leg pain reduction compared to baseline in each treatment arm
Time frame: Weeks 12 and 25, and Months 12, 18 and 24
Effectiveness of targeted, back and/or leg pain reduction compared to baseline in each treatment arm
Time frame: Weeks 12 and 25, and Months 12, 18 and 24
Change in targeted, back and/or leg pain compared to baseline in each treatment arm
Time frame: Weeks 12 and 25, and Months 12, 18 and 24
Change in targeted, back and/or leg pain compared to baseline in each treatment arm
Time frame: Weeks 12 and 25, and Months 12, 18 and 24
Clinician Global Impression of Change score in each treatment arm
Time frame: Weeks 12 and 25, and Months 12, 18 and 24
Change in disability compared to baseline in each treatment arm
Time frame: Weeks 12 and 25, and Months 12, 18 and 24
Change in quality of life compared to baseline in each treatment arm
Time frame: Weeks 12 and 25, and Months 12, 18 and 24
Change in patient activity per the Pain Disability Index score in each treatment arm
Time frame: Weeks 12 and 25, and Months 12, 18 and 24
Patient Global Impression of Change score in each treatment arm
Time frame: Weeks 12 and 25, and Months 12, 18 and 24
Participant satisfaction per the subject satisfaction survey outcome in each treatment arm
Time frame: Weeks 12 and 25, and Months 12, 18 and 24
Evaluation of trial success rates
Time frame: From Trial Implant to End of Trail
Rate of surgical re-intervention of the SCS system
Time frame: From Permanent Implant through Month 24
Results and safety
The study was stopped early (reason given: Sponsor bankruptcy). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Mar 2021.
- 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.
Ben Tranchina study director
Nuvectra
10 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Ultra-high pulse width stimulation and Traditional pulse width stimulation in people with Chronic Pain, run by Nuvectra at 10 sites 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 10 inclusion and 9 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: stopped early, as of the sponsor's last update on 11 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 10 sites 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?
The study was stopped early (reason given: Sponsor bankruptcy). Results are not available in the source record.
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?
Effectiveness of targeted pain reduction compared to baseline in each treatment arm (time frame: Week 25). The study lists 2 primary outcomes in all. 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 11 Mar 2021.