Evaluating the Statistical Robustness of Randomized Controlled Trials of Spinal Cord Stimulation for Pain through the Use of Fragility Index
Year: 2025
Type: article
Language: en
Topic: Pain Management and Treatment
Authors and affiliations:
raw_author_name: Nasir Hussain
raw_affiliation_strings: Nasir Hussain, M.D., M.Sc.: Department of Anesthesiology, Wexner Medical Center, Ohio State University Columbus, Ohio
Department of Anesthesiology, The Ohio State University Wexner Medical Center, Columbus, OH, USA
raw_author_name: Richard Brull
raw_affiliation_strings: Richard Brull, M.D.: Department of Anesthesiology and Pain Medicine, University of Toronto, Toronto, Canada
Conflicts of Interest: RSD receives external grant funding from Nevro Corp, Saol Therapeutics, and Vertex Pharmaceutical. TEW receives external grant funding from Medtronic Inc. No other authors declare a conflict of interest
Summary Statement: This study highlights that the majority of RCTs on spinal cord stimulation used for chronic pain are statistically robust, emphasizing the importance of fragility indices to improve clinical trial interpretation and clinical decision-making
Submitted for publication June 24, 2025. Accepted for publication November 24, 2025
raw_author_name: Raghav Shah
raw_affiliation_strings: Raghav Shah, B.S., M.D. (Cand.): Northeast Ohio Medical University College of Medicine, Rootstown, Ohio
Submitted for publication June 24, 2025. Accepted for publication November 24, 2025
Northeast Ohio Medical University, Rootstown, OH, USA
Conflicts of Interest: RSD receives external grant funding from Nevro Corp, Saol Therapeutics, and Vertex Pharmaceutical. TEW receives external grant funding from Medtronic Inc. No other authors declare a conflict of interest
Summary Statement: This study highlights that the majority of RCTs on spinal cord stimulation used for chronic pain are statistically robust, emphasizing the importance of fragility indices to improve clinical trial interpretation and clinical decision-making
raw_author_name: Jordan Bozer
raw_affiliation_strings: Jordan Bozer, M.D.: Department of Anesthesiology, Wexner Medical Center, Ohio State University, Columbus, Ohio
Conflicts of Interest: RSD receives external grant funding from Nevro Corp, Saol Therapeutics, and Vertex Pharmaceutical. TEW receives external grant funding from Medtronic Inc. No other authors declare a conflict of interest
Department of Anesthesiology, The Ohio State University Wexner Medical Center, Columbus, OH, USA
Summary Statement: This study highlights that the majority of RCTs on spinal cord stimulation used for chronic pain are statistically robust, emphasizing the importance of fragility indices to improve clinical trial interpretation and clinical decision-making
Submitted for publication June 24, 2025. Accepted for publication November 24, 2025
raw_author_name: Ryan S. D’Souza
raw_affiliation_strings: Ryan S. D’Souza, M.D.: Department of Anesthesiology and Perioperative Medicine, Mayo Clinic, Rochester, Minnesota
Department of Anesthesiology and Perioperative Medicine, Mayo Clinic, Rochester, MN, USA
Submitted for publication June 24, 2025. Accepted for publication November 24, 2025
Summary Statement: This study highlights that the majority of RCTs on spinal cord stimulation used for chronic pain are statistically robust, emphasizing the importance of fragility indices to improve clinical trial interpretation and clinical decision-making
Conflicts of Interest: RSD receives external grant funding from Nevro Corp, Saol Therapeutics, and Vertex Pharmaceutical. TEW receives external grant funding from Medtronic Inc. No other authors declare a conflict of interest
raw_author_name: Jay Karri
raw_affiliation_strings: Jay Karri, M.D.: Department of Orthopedic Surgery and Anesthesiology, School of Medicine, University of Maryland, Baltimore, Maryland
Conflicts of Interest: RSD receives external grant funding from Nevro Corp, Saol Therapeutics, and Vertex Pharmaceutical. TEW receives external grant funding from Medtronic Inc. No other authors declare a conflict of interest
Submitted for publication June 24, 2025. Accepted for publication November 24, 2025
Department of Orthopedic Surgery and Anesthesiology, University of Maryland School of Medicine, Baltimore, MD, USA
Summary Statement: This study highlights that the majority of RCTs on spinal cord stimulation used for chronic pain are statistically robust, emphasizing the importance of fragility indices to improve clinical trial interpretation and clinical decision-making
raw_author_name: Tristan Weaver
raw_affiliation_strings: Tristan Weaver, M.D.: Department of Anesthesiology, Wexner Medical Center, Ohio State University, Columbus, Ohio
Summary Statement: This study highlights that the majority of RCTs on spinal cord stimulation used for chronic pain are statistically robust, emphasizing the importance of fragility indices to improve clinical trial interpretation and clinical decision-making
Conflicts of Interest: RSD receives external grant funding from Nevro Corp, Saol Therapeutics, and Vertex Pharmaceutical. TEW receives external grant funding from Medtronic Inc. No other authors declare a conflict of interest
Submitted for publication June 24, 2025. Accepted for publication November 24, 2025
Department of Anesthesiology, The Ohio State University Wexner Medical Center, Columbus, OH, USA
raw_author_name: Larry J. Prokop
raw_affiliation_strings: Larry J. Prokop, M.L.S.: Library Public Services, Mayo Clinic, Rochester, Minnesota
Summary Statement: This study highlights that the majority of RCTs on spinal cord stimulation used for chronic pain are statistically robust, emphasizing the importance of fragility indices to improve clinical trial interpretation and clinical decision-making
Conflicts of Interest: RSD receives external grant funding from Nevro Corp, Saol Therapeutics, and Vertex Pharmaceutical. TEW receives external grant funding from Medtronic Inc. No other authors declare a conflict of interest
Submitted for publication June 24, 2025. Accepted for publication November 24, 2025
Library Public Services, Mayo Clinic, Rochester, Minnesota
raw_author_name: Faraj W. Abdallah
raw_affiliation_strings: Faraj W. Abdallah, M.D., M.Sc.: Department of Anesthesiology and Pain Medicine, and Ottawa Hospital Research Institute, University of Ottawa, Ottawa, Canada; Department of Anesthesia, and Li Ka Shing Knowledge Institute, St. Michael’s Hospital, University of Toronto, Toronto, Canada
Conflicts of Interest: RSD receives external grant funding from Nevro Corp, Saol Therapeutics, and Vertex Pharmaceutical. TEW receives external grant funding from Medtronic Inc. No other authors declare a conflict of interest
Summary Statement: This study highlights that the majority of RCTs on spinal cord stimulation used for chronic pain are statistically robust, emphasizing the importance of fragility indices to improve clinical trial interpretation and clinical decision-making
Department of Anesthesiology and Pain Medicine, and the Ottawa Hospital Research Institute, University of Ottawa, Ottawa, Ontario, Canada
Submitted for publication June 24, 2025. Accepted for publication November 24, 2025
Department of Anesthesia, and the Li Ka Shing Knowledge Institute, St. Michael’s Hospital, University of Toronto, Toronto, Ontario, Canada