Chronic PainFASTNCT04618471
Paresthesia-Free Fast-Acting Subperception (FAST) Study
A study testing Boston Scientific WaveWriter SCS System in people with Chronic Pain, run by Boston Scientific Corporation at 13 sites in United States.
Trial summary
Study to evaluate the effectiveness of FAST-SCS (fast-acting paresthesia-free therapy) and additional SCS therapy options in patients with chronic pain using Boston Scientific WaveWriter SCS Systems. Read more about this study
- Who is it for?
- Ages 22 years and older
- Conditions the study is for
- Chronic Pain
- What is being tested?
- Boston Scientific WaveWriter SCS System
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 177 participants
- Where
- 13 sitesUnited States
- Study dates
- 10 Feb 2021to Mar 2029
- 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 22 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Chronic pain (predominantly neuropathic) of the trunk and/or limbs for at least 6 months with back pain greater or equal to leg pain.
- 22 years of age or older when written informed consent is obtained
- Able to independently read and complete all questionnaires and assessments provided in English
- Signed a valid, IRB-approved informed consent form (ICF) provided in English
Who cannot join
- Any pain-related diagnosis or medical/psychological condition or external factors that, in the clinician's best judgment, might confound reporting of study outcomes
- Significant cognitive impairment that, in the opinion of the Investigator, would reasonably be expected to impair the study candidate's ability to participate in the study
- Breast-feeding or planning to get pregnant during the course of the study or not using adequate contraception
- Participating, or intends to participate, in another clinical trial that may influence the data that will be collected for this study
Trial locations and contacts
13 sites in 1 country.
13 sites in 1 country
United States13 sites
Acute and Chronic Pain Therapies
Bellevue, Washington, 98005
Goodman Campbell Brain and Spine
Carmel, Indiana, 46032
University of Chicago Hospital
Chicago, Illinois, 60637
Orlando Health Neuroscience Institute
Clermont, Florida, 34711
Cleveland Clinic Foundation
Cleveland, Ohio, 44195
Pacific Sports and Spine, LLC
Eugene, Oregon, 97401
The Orthopaedic Institute
Gainesville, Florida, 32607
PCPMG Clinical Research Unit, LLC
Greenville, South Carolina, 29601
Denver Back Pain Specialists
Greenwood Village, Colorado, 80111
Vitamed Research
Palm Desert, California, 92260
Willis-Knighton River Cities Clinical Research Center
Shreveport, Louisiana, 71105
Montefiore Medical Center
The Bronx, New York, 10461
The Center for Clinical Research
Winston-Salem, North Carolina, 27103
About this study
Official title: Study to Demonstrate the Value of Paresthesia-Free Fast-Acting Subperception (FAST) and Other SCS Therapies Using WaveWriter™ Spinal Cord Stimulator Systems in the Treatment of Chronic Pain
Study to evaluate the effectiveness of FAST-SCS (fast-acting paresthesia-free therapy) and additional SCS therapy options in patients with chronic pain using Boston Scientific WaveWriter SCS Systems.
- Conditions
- Chronic Pain
- Being tested
- Boston Scientific WaveWriter SCS System
- Keywords
- Spinal Cord 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.
Boston Scientific WaveWriter SCS SystemDevice
WaveWriter SCS Programming
| Study group | Role | What they receive |
|---|---|---|
| WaveWriter Settings | Experimental | Not described Receives: Device: Boston Scientific WaveWriter SCS System |
What is being measured
The primary outcome is the main question the study is designed to answer.
Targeted Pain Responder Rate
Proportion of subjects with 50% or greater reduction from Baseline Visit in average targeted pain intensity at 3 months post-activation
Measured: 3 months post-activation
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Nov 2020
- Study start10 Feb 2021
- Primary completion14 Dec 2022
- Study completionMar 2029 (estimated)
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 (1)Papers the sponsor has linked to this study.
- Other trials for Chronic PainStudies of the same condition, open and under way.
- More trials run by Boston Scientific CorporationThe sponsor's other registered studies.
- 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
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 177 participants (actual)
Sponsor and investigators
- Lead sponsor
- Boston Scientific Corporation
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Natalie Bloom Lyons, Study director, Boston Scientific Corporation
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04618471
- Sponsor's protocol ID
- A4099
- Acronym
- FAST
- Status last verified
- Oct 2026
- First submitted
- 31 Oct 2020
- Last updated
- 9 Oct 2026
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
Publications
Anitescu M, Loudermilk E, North J, Wahezi S, Antony A, Leier T, Trainor D, Noles J, Moore G, Lee J, Paez J, Wilson D, Van Belleghem V, Goldberg E. Pain Relief and Multidimensional Outcomes of Fast-Acting Subperception Spinal Cord Stimulation Therapy for Chronic Pain: The FAST Prospective, Multicenter Study. Pain Ther. 2026 Jun;15(3):643-662. doi: 10.1007/s40122-026-00823-0. Epub 2026 Mar 10.
PubMed 41803572
Study at a glance
From the registry record, last updated by the sponsor on 9 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Study to Demonstrate the Value of Paresthesia-Free Fast-Acting Subperception (FAST) and Other SCS Therapies Using WaveWriter™ Spinal Cord Stimulator Systems in the Treatment of Chronic Pain
- ClinicalTrials.gov ID
- NCT04618471
- Acronym / sponsor ID
- FAST / A4099
- Conditions
- Chronic Pain
- Keywords
- Spinal Cord Stimulation
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 177 participants (actual)
- Lead sponsor
- Boston Scientific CorporationIndustry (pharma, biotech, devices)
- Study start
- 10 Feb 2021 (actual)
- Primary completion
- 14 Dec 2022 (actual)
- Study completion
- Mar 2029 (estimated)
- First posted
- 6 Nov 2020 (actual)
- Results
- Posted 29 Dec 2023
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Study to evaluate the effectiveness of FAST-SCS (fast-acting paresthesia-free therapy) and additional SCS therapy options in patients with chronic pain using Boston Scientific WaveWriter SCS Systems.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| WaveWriter Settings | Experimental | Device: Boston Scientific WaveWriter SCS System |
Who may qualify
- Ages
- 22 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Chronic pain (predominantly neuropathic) of the trunk and/or limbs for at least 6 months with back pain greater or equal to leg pain.
- 22 years of age or older when written informed consent is obtained
- Able to independently read and complete all questionnaires and assessments provided in English
- Signed a valid, IRB-approved informed consent form (ICF) provided in English
Key exclusion criteria (4 listed)
- Any pain-related diagnosis or medical/psychological condition or external factors that, in the clinician's best judgment, might confound reporting of study outcomes
- Significant cognitive impairment that, in the opinion of the Investigator, would reasonably be expected to impair the study candidate's ability to participate in the study
- Breast-feeding or planning to get pregnant during the course of the study or not using adequate contraception
- Participating, or intends to participate, in another clinical trial that may influence the data that will be collected for this study
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 |
|---|---|---|
| Boston Scientific WaveWriter SCS SystemWaveWriter SCS Programming | Device | WaveWriter Settings |
Primary outcome
Targeted Pain Responder Rate
Time frame: 3 months post-activation
Proportion of subjects with 50% or greater reduction from Baseline Visit in average targeted pain intensity at 3 months post-activation
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Oct 2026.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 41803572Anitescu M, Loudermilk E, North J, Wahezi S, Antony A, Leier T, Trainor D, Noles J, Moore G, Lee J, Paez J, Wilson D, Van Belleghem V, Goldberg E. Pain Relief and Multidimensional Outcomes of Fast-Acting Subperception Spinal Cord Stimulation Therapy for Chronic Pain: The FAST Prospective, Multicenter Study. Pain Ther. 2026 Jun;15(3):643-662. doi: 10.1007/s40122-026-00823-0. Epub 2026 Mar 10.
Related trials for Chronic Pain
Recruiting
The Intervention Effect of Exercise on Lumbar Multifidus Muscle Injuries
Chronic Non-specific Low Back Pain, Lumbar Multifidus Muscle Injury
Not yet recruiting
Acceptance and Commitment Therapy Plus Physiotherapy for Chronic Low Back Pain
Low Back Pain
Not yet recruiting
Erector Spinae Plane Block With or Without Thoracolumbar Fascia Injection for Chronic Low Back Pain
Chronic Low Back Pain
Recruiting
Healing Track Clinical Trial
Chronic Back Pain
Active, not recruitingObservational study
Lemborexant vs Clonidine vs Sedatives to Treat Insomnia in Chronic Pain Patients
Chronic Insomnia, Chronic Pain
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.
Natalie Bloom Lyons study director
Boston Scientific Corporation
13 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Boston Scientific WaveWriter SCS System in people with Chronic Pain, run by Boston Scientific Corporation at 13 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 4 inclusion and 4 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: under way, not looking for participants, as of the sponsor's last update on 9 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 13 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?
Yes. Results are posted in the registry (first posted 29 Dec 2023). 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?
Targeted Pain Responder Rate (time frame: 3 months post-activation). 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 NCT04618471, which also lists 1 linked publication.
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 9 Oct 2026.