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.

Active, not recruiting

Under way, not looking for participants. Everyone needed has enrolled. The study is still running.

Official record

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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.

City, postcode or hospital

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

Other trials in United States

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 groups in NCT04618471
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.

10 Feb 2021Mar 2029

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)

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

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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All Chronic Pain trials

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

Results posted to the registry on 29 Dec 2023, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
WaveWriter Settings	177	20

Primary outcome: Targeted Pain Responder Rate

Time frame: 3 months post-activation. Count of participants. Unit: Participants

Measure	WaveWriter Settings n = 20
Value	16

Population analysed: Interim analysis of 20 activated subjects at 3-Month Visit.

Adverse events

Time frame: Adverse Event Rates for all Subjects at time of the pre-specified primary endpoint analysis for 20 activated subjects at 3-Month Visit, approximately 7-8 months post informed consent.. Other adverse events reported at 0% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
WaveWriter Settings	6 of 104 (5.8%)	6 of 104 (5.8%)	0 of 104

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

Enrolling by invitation
Efficacy of a Chronic Pain Treatment Prior to Gender-affirming Surgery
Pain Catastrophizing, Pain, Chronic
Not yet recruiting
Multicomponent Exercise and Pain Science Education for Fall Prevention in Older Adults With Chronic Musculoskeletal Pain (MovePainFall)
Chronic Pain, Musculoskeletal Pain
Recruiting
Studying Melatonin and Recovery in Teens
Juvenile; Scoliosis, Scoliosis Idiopathic
Recruiting
Uncovering the Mechanism of Pain Relief by Peripheral Transcutaneous Magnetic Stimulation
Post-Surgical Pain, Chronic, Post-traumatic Pain, Chronic
Recruiting
Daily Knee Sleeve Use Versus No Use in Older Adults With Chronic Knee Pain
Knee Arthritis, Osteoarthritis

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.