Radiofrequency (RF) Ablation Prospective Outcomes Study (RAPID)

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 Overview

• Status: Completed
• Conditions: Pain, Chronic
• Intervention / Treatment: Device: Radiofrequency Ablation

• Study Type: Observational
• Enrollment (Actual): 298

Contacts and Locations

Study Locations

• Belgium
  • Antwerp, Belgium
    • ZNA Hoge Beuken
  • Bruges, Belgium
    • St. Jan
• Italy
  • Olbia, Italy
    • Mater Olbia Hospital
• Netherlands
  • Geldrop, Netherlands
    • St. Anna Hospital
• United States
  • Arizona
    • Mesa, Arizona, United States, 85203
      • Elite Pain and Spine Institute
    • Tucson, Arizona, United States, 85712
      • Tucson Orthopaedic Institute
  • Connecticut
    • Westport, Connecticut, United States, 06880
      • The Spine Wellness Center in Westport
  • Georgia
    • Atlanta, Georgia, United States, 30309
      • Shepherd Center
  • Illinois
    • Quincy, Illinois, United States, 62301
      • Quincy Medical Group
  • Minnesota
    • Edina, Minnesota, United States, 55439
      • Twin Cities Pain Clinic and Surgery Center
  • North Carolina
    • Huntersville, North Carolina, United States, 28078
      • Carolinas Research Institute
  • Ohio
    • Cincinnati, Ohio, United States, 45219
      • UC Health Pain Medicine
    • Loveland, Ohio, United States, 45140
      • Premier Pain Treatment Institute
    • Toledo, Ohio, United States, 43623
      • Toledo Clinic
  • Pennsylvania
    • Sewickley, Pennsylvania, United States, 15143
      • Pain Diagnostics and Interventional Care

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 1 second and older (Child, Adult, Older Adult)
• Accepts Healthy Volunteers: No

• Sampling Method: Non-Probability Sample

Study Population

Patients with Chronic Pain

Description

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

Study Plan

How is the study designed?

Design Details

• Observational Models: Cohort
• Time Perspectives: Prospective

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Boston Scientific Radiofrequency Ablation Systems; Subjects with pain treated with a commercially approved Boston Scientific RF system	Device: Radiofrequency Ablation; Radiofrequency Ablation for treatment of chronic pain

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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	12-months post-procedure

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Responder Rate	Percentage of subjects with a 30 percent or greater reduction from Baseline in targeted pain intensity	12-months post-procedure

Collaborators and Investigators

• Sponsor: Boston Scientific Corporation
• Investigators: Study Director: Natalie Bloom Lyons, M.S., Boston Scientific Corporation

Publications and helpful links

General 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.
• 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. 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.

Study record dates

Study Major Dates

• Study Start (Actual): December 22, 2020
• Primary Completion (Actual): February 7, 2025
• Study Completion (Actual): February 7, 2025

Study Registration Dates

• First Submitted: December 12, 2020
• First Submitted That Met QC Criteria: December 12, 2020
• First Posted (Actual): December 17, 2020

Study Record Updates

• Last Update Posted (Actual): April 15, 2026
• Last Update Submitted That Met QC Criteria: April 3, 2026
• Last Verified: April 1, 2026

More Information

Terms related to this study

• Keywords: Radiofrequency (RF)
• Additional Relevant MeSH Terms: Pain; Neurologic Manifestations; Pathological Conditions, Signs and Symptoms; Signs and Symptoms; Chronic Pain; Therapeutics; Surgical Procedures, Operative; Ablation Techniques; Radiofrequency Therapy; Radiofrequency Ablation
• Other Study ID Numbers: A4087; A4106 (Boston Scientific Corporation)

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: Yes