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  4. Treatment of Chronic Abdominal Pain With 10-kHz Spinal Cord Stimulation: Safety and Efficacy Results From a 12-Month Prospective, Multicenter, Feasibility Study

Treatment of Chronic Abdominal Pain With 10-kHz Spinal Cord Stimulation: Safety and Efficacy Results From a 12-Month Prospective, Multicenter, Feasibility Study

Clinical and Translational Gastroenterology, 2020 · DOI: https://doi.org/10.14309/ctg.0000000000000133 · Published: February 7, 2020

NeurologyPain ManagementGastroenterology

Simple Explanation

Chronic abdominal pain (CAP) can arise from multiple conditions, including inflammatory disorders, trauma because of injury or surgery, or structural or functional causes. This study evaluated the safety and efficacy of 10-kHz spinal cord stimulation (SCS) in patients with intractable CAP over a 12-month follow-up period. After 12 months of treatment with 10-kHz SCS, 78.3% of subjects were responders (pain relief of ‡50%) and 14 of 22 subjects (63.6%) were remitters (sustained £3.0-cm visual analog scale scores).

Study Duration
12 Months
Participants
24 subjects with intractable CAP
Evidence Level
Prospective, single-arm, multicenter feasibility study

Key Findings

  • 1
    After 12 months of treatment with 10-kHz SCS, 78.3% of subjects were responders (pain relief of ‡50%).
  • 2
    14 of 22 subjects (63.6%) were remitters (sustained £3.0-cm visual analog scale scores).
  • 3
    Secondary outcomes, including assessments of disability, mental and physical well-being, sleep quality, perception of improvement, and satisfaction, showed that 10-kHz SCS greatly improved the quality of life of patients with CAP.

Research Summary

This prospective, single-arm study was designed to evaluate the safety and efficacy of 10-kHz spinal cord stimulation (SCS) in patients with intractable CAP over a 12-month follow-up period. After 12 months of treatment with 10-kHz SCS, 78.3% of subjects were responders and 63.6% were remitters. Observationally, most subjects also reported concurrent reduction or resolution of nausea and/or vomiting.

Practical Implications

Clinical Practice

10-kHz SCS can be considered as a treatment option for patients with intractable CAP, especially when conventional therapies have failed.

Future Research

A larger randomized controlled study is needed to further confirm the results from the current feasibility study.

Device Labeling

Provides information relevant to adding specific language for chronic abdominal or visceral pain to labeling for spinal cord stimulators.

Study Limitations

  • 1
    Lack of a control group
  • 2
    Randomization not performed
  • 3
    Potential selection bias in the patient population

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