Radiofrequency (RF) Ablation Prospective Outcomes Study

Conditions

Pain, Chronic

Keywords

Radiofrequency (RF)

Brief 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

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.

2025-08-23

10.1016/j.inpm.2025.100623

Assessment of real-world, prospective outcomes in patients treated with lumbar radiofrequency ablation for chronic pain (RAPID).

Provenzano 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.

2025-04-243 citations

10.1016/j.inpm.2025.100576

B363 Rapid: an international, prospective, multicenter study of radiofrequency ablation outcomes in chronic pain patients

J Atallah, Bradley Holt, K Lechleiter, R Jain

Chronic Pain & Management2022-06-01

10.1136/rapm-2022-esra.439

Interventions

DEVICERadiofrequency Ablation

Radiofrequency Ablation for treatment of chronic pain

Study design

Observational model

COHORT

Time perspective

PROSPECTIVE

Eligibility

Sex/Gender

ALL

Age

0 Years to No maximum

Healthy volunteers

No

Inclusion criteria

Key Inclusion Criteria: * 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

* 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

Design outcomes

Primary

Measure	Time frame	Description
Patient Global Impression of Change (PGIC)	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

Countries

Belgium, Italy, Netherlands, United States

Contacts

STUDY_DIRECTORNatalie Bloom Lyons, M.S.

Boston Scientific Corporation

Baseline characteristics

Characteristic	—
Age, Continuous	61.5 years STANDARD_DEVIATION 12.9
Numeric Rating Scale	6.5 units on a scale STANDARD_DEVIATION 1.9
Race/Ethnicity, Customized American Indian or Alaska native	1 participants in category
Race/Ethnicity, Customized Asian	1 participants in category
Race/Ethnicity, Customized Black, of African heritage	15 participants in category
Race/Ethnicity, Customized Data Missing	28 participants in category
Race/Ethnicity, Customized Hispanic or Latino	14 participants in category
Race/Ethnicity, Customized Native Hawaiian or other Pacific Islander	1 participants in category
Race/Ethnicity, Customized Not disclosed	1 participants in category
Race/Ethnicity, Customized Other	1 participants in category
Race/Ethnicity, Customized White	235 participants in category
Region of Enrollment Belgium	18 participants
Region of Enrollment Netherlands	13 participants
Region of Enrollment United States	263 participants
Sex: Female, Male Female	164 Participants
Sex: Female, Male Male	130 Participants

Adverse events

Event type	EG000 affected / at risk
deaths Total, all-cause mortality	0 / 298
other Total, other adverse events	0 / 298
serious Total, serious adverse events	44 / 298

Outcome results

None listed