Pain, ChronicRAPIDNCT04673032
Radiofrequency (RF) Ablation Prospective Outcomes Study
An observational study of Pain, Chronic, run by Boston Scientific Corporation at 15 sites in 4 countries.
Trial summary
The objective of this study is to compile real-world outcomes of Boston Scientific commercially approved radiofrequency (RF) ablation systems in the treatment of patients diagnosed with pain Read more about this study
- Who is it for?
- Ages 0 years and older
- Conditions the study is for
- Pain, Chronic
- What is being tested?
- Radiofrequency Ablation
- Type of treatment
- Medical device
- How many people
- 298 participants
- Where
- 15 sitesin 4 countries
- Study dates
- 22 Dec 2020to 7 Feb 2025
- How long will I take part?
- 12 Months
- Phase
- Observational
- 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 0 years and older
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: Patients with Chronic Pain
Who may be able to join
- Study candidate is scheduled to be treated with a commercially approved Boston Scientific RF system for pain per local Directions for Use (DFU)
- Signed a valid, IRB/EC/REB-approved informed consent form
Who cannot join
- Meets any contraindications per locally applicable Directions for Use (DFU)
- Currently diagnosed with cognitive impairment, or exhibits any characteristic, that would limit study candidate's ability to assess pain relief or to complete study assessments
Trial locations and contacts
15 sites in 4 countries.
15 sites in 4 countries
United States11 sites
Shepherd Center
Atlanta, Georgia, 30309
UC Health Pain Medicine
Cincinnati, Ohio, 45219
Twin Cities Pain Clinic and Surgery Center
Edina, Minnesota, 55439
Carolinas Research Institute
Huntersville, North Carolina, 28078
Premier Pain Treatment Institute
Loveland, Ohio, 45140
Elite Pain and Spine Institute
Mesa, Arizona, 85203
Quincy Medical Group
Quincy, Illinois, 62301
Pain Diagnostics and Interventional Care
Sewickley, Pennsylvania, 15143
Toledo Clinic
Toledo, Ohio, 43623
Tucson Orthopaedic Institute
Tucson, Arizona, 85712
The Spine Wellness Center in Westport
Westport, Connecticut, 06880
About this study
The objective of this study is to compile real-world outcomes of Boston Scientific commercially approved radiofrequency (RF) ablation systems in the treatment of patients diagnosed with pain
- Conditions
- Pain, Chronic
- Being tested
- Radiofrequency Ablation
- Keywords
- Radiofrequency (RF)
- Medical subject headings
- Chronic Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Radiofrequency AblationDevice
Radiofrequency Ablation for treatment of chronic pain
| Study group | Role | What they receive |
|---|---|---|
| Boston Scientific Radiofrequency Ablation Systems | Subjects with pain treated with a commercially approved Boston Scientific RF system Receives: Device: Radiofrequency Ablation |
What is being measured
The primary outcome is the main question the study is designed to answer.
Patient Global Impression of Change (PGIC)
Using the Patient Global Impression of Change (PGIC) Scale, subjects will rate themselves as: very much improved; much improved; minimally improved; no change; minimally worse; much worse; or very much worse compared with Baseline
Measured: 12-months post-procedure
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Dec 2020
- Study start22 Dec 2020
- Primary completion7 Feb 2025
- Study completion7 Feb 2025
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 (2)Papers the sponsor has linked to this study.
- Other trials for Pain, ChronicStudies 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 298 participants (actual)
- Target duration
- 12 Months
Sponsor and investigators
- Lead sponsor
- Boston Scientific Corporation
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Natalie Bloom Lyons, M.S., Study director, Boston Scientific Corporation
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04673032
- Sponsor's protocol ID
- A4087
- Acronym
- RAPID
- Status last verified
- Apr 2026
- First submitted
- 12 Dec 2020
- Last updated
- 15 Apr 2026
- Results posted
- Yes, on ClinicalTrials.gov
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
Publications
Provenzano DA, Holt B, Danko M, Atallah J, Iqbal M, Shah B, Singh A, Sachdeva H, Donck EV, Liebrand B, Shaw E, Haas S, Sekhar R, Pan A, Halperin DS, Goldberg E. Assessment of real-world, prospective outcomes in patients treated with cervical radiofrequency ablation for chronic pain (RAPID). Interv Pain Med. 2025 Aug 23;4(3):100623. doi: 10.1016/j.inpm.2025.100623. eCollection 2025 Sep.
PubMed 40896553Provenzano DA, Holt B, Danko M, Atallah J, Iqbal M, Shah B, Singh A, Sachdeva H, Donck EV, Shaw E, Haas S, Sekhar R, Pan A, Halperin DS, Goldberg E. Assessment of real-world, prospective outcomes in patients treated with lumbar radiofrequency ablation for chronic pain (RAPID). Interv Pain Med. 2025 Apr 24;4(2):100576. doi: 10.1016/j.inpm.2025.100576. eCollection 2025 Jun.
PubMed 40342788
Study at a glance
From the registry record, last updated by the sponsor on 15 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Radiofrequency (RF) Ablation Prospective Outcomes Study
- ClinicalTrials.gov ID
- NCT04673032
- Acronym / sponsor ID
- RAPID / A4087
- Conditions
- Pain, Chronic
- Keywords
- Radiofrequency (RF)
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 298 participants (actual)
- Lead sponsor
- Boston Scientific CorporationIndustry (pharma, biotech, devices)
- Study start
- 22 Dec 2020 (actual)
- Primary completion
- 7 Feb 2025 (actual)
- Study completion
- 7 Feb 2025 (actual)
- First posted
- 17 Dec 2020 (actual)
- Results
- Posted 15 Apr 2026
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 compile real-world outcomes of Boston Scientific commercially approved radiofrequency (RF) ablation systems in the treatment of patients diagnosed with pain
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 12 Months
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Boston Scientific Radiofrequency Ablation Systems | – | Device: Radiofrequency AblationSubjects with pain treated with a commercially approved Boston Scientific RF system |
Who may qualify
- Ages
- 0 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- Patients with Chronic Pain
Key inclusion criteria (2 listed)
- Study candidate is scheduled to be treated with a commercially approved Boston Scientific RF system for pain per local Directions for Use (DFU)
- Signed a valid, IRB/EC/REB-approved informed consent form
Key exclusion criteria (2 listed)
- Meets any contraindications per locally applicable Directions for Use (DFU)
- Currently diagnosed with cognitive impairment, or exhibits any characteristic, that would limit study candidate's ability to assess pain relief or to complete study assessments
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 |
|---|---|---|
| Radiofrequency AblationRadiofrequency Ablation for treatment of chronic pain | Device | Boston Scientific Radiofrequency Ablation Systems |
Primary outcome
Patient Global Impression of Change (PGIC)
Time frame: 12-months post-procedure
Using the Patient Global Impression of Change (PGIC) Scale, subjects will rate themselves as: very much improved; much improved; minimally improved; no change; minimally worse; much worse; or very much worse compared with Baseline
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Apr 2026.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 40896553Provenzano DA, Holt B, Danko M, Atallah J, Iqbal M, Shah B, Singh A, Sachdeva H, Donck EV, Liebrand B, Shaw E, Haas S, Sekhar R, Pan A, Halperin DS, Goldberg E. Assessment of real-world, prospective outcomes in patients treated with cervical radiofrequency ablation for chronic pain (RAPID). Interv Pain Med. 2025 Aug 23;4(3):100623. doi: 10.1016/j.inpm.2025.100623. eCollection 2025 Sep.
- Derived from this study: PubMed 40342788Provenzano DA, Holt B, Danko M, Atallah J, Iqbal M, Shah B, Singh A, Sachdeva H, Donck EV, Shaw E, Haas S, Sekhar R, Pan A, Halperin DS, Goldberg E. Assessment of real-world, prospective outcomes in patients treated with lumbar radiofrequency ablation for chronic pain (RAPID). Interv Pain Med. 2025 Apr 24;4(2):100576. doi: 10.1016/j.inpm.2025.100576. eCollection 2025 Jun.
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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.
Natalie Bloom Lyons, M.S. study director
Boston Scientific Corporation
15 sites in 4 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Pain, Chronic, run by Boston Scientific Corporation at 15 sites in 4 countries.
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 2 inclusion and 2 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 15 Apr 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 15 sites in United States, Belgium, Italy, Netherlands. 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 15 Apr 2026). 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?
Patient Global Impression of Change (PGIC) (time frame: 12-months post-procedure). 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 NCT04673032, which also lists 2 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 15 Apr 2026.