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Efficacy of ganglion impar block combined with pudendal nerve pulsed radiofrequency for pudendal neuralgia management-a randomized clinical trial.

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  • Additional Information
    • Source:
      Publisher: BioMed Central Country of Publication: England NLM ID: 101263253 Publication Model: Electronic Cited Medium: Internet ISSN: 1745-6215 (Electronic) Linking ISSN: 17456215 NLM ISO Abbreviation: Trials Subsets: MEDLINE
    • Publication Information:
      Original Publication: [London] : BioMed Central, 2006-
    • Subject Terms:
      Pudendal Neuralgia*/therapy ; Pudendal Nerve* ; Pulsed Radiofrequency Treatment*/methods ; Randomized Controlled Trials as Topic* ; Pain Measurement*; Humans ; Treatment Outcome ; Middle Aged ; Male ; Female ; Adult ; Combined Modality Therapy ; Aged ; Autonomic Nerve Block/methods ; Young Adult ; Pain Management/methods
    • Abstract:
      Background: Pudendal neuralgia is a chronic and debilitating condition. Its prevalence ranges from 5 to 26%. Currently, therapeutic approaches to treat pudendal neuralgia include patient education, medication management, psychological and physical therapy, and procedural interventions, such as nerve block, trigger point injections, and surgery. Drug therapy has a limited effect on pain relief. A pudendal nerve block may cause a significant decrease in pain scores for a short time; however, its efficacy significantly decreases over time. In contrast, pudendal nerve pulsed radiofrequency can provide pain relief for 3 months, and ganglion impar block has been widely used for treating chronic perineal pain and chronic coccygodynia. This study aimed to determine the efficacy and safety of monotherapy (pudendal nerve pulsed radiofrequency) and combination therapy (pudendal nerve pulsed radiofrequency plus ganglion impar block) in patients with pudendal neuralgia.
      Methods: This randomized, controlled clinical trial will include 84 patients with pudendal neuralgia who failed to respond to drug or physical therapy. Patients will be randomly assigned into one of the two groups: mono or combined treatment groups. The primary outcome will be a change in pain intensity measured using the visual analog scale. The secondary outcomes will include a Self-Rating Anxiety Scale score, Self-Rating Depression Scale score, the use of oral analgesics, the Medical Outcomes Study Health Survey Short Form-36 Item score, and the occurrence of adverse effects. The study results will be analyzed using intention-to-treat and per-protocol analyses. Primary and secondary outcomes will be evaluated between the mono and combined treatment groups. Subgroup analyses will be conducted based on the initial ailment, age, and baseline pain intensity. The safety of the treatment will be assessed by monitoring adverse events, which will be compared between the two groups.
      Discussion: This study protocol describes a randomized, controlled clinical trial to determine the efficacy and safety of mono and combination therapies in patients with pudendal neuralgia. The study results will provide valuable information on the potential benefits of this combination therapy and contribute to the development of more effective and safer treatments for patients with pudendal neuralgia.
      Trial Registration: Chinese Clinical Trial Registry (ChiCTR2200061800).
      (© 2024. The Author(s).)
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    • Grant Information:
      2021YF2009105 the National Key Research and Development Program of China; No. 2022HXFH035 West China Hospital, Sichuan University
    • Contributed Indexing:
      Keywords: Ganglion impar block; Pudendal nerve block; Pudendal neuralgia; Pulsed radiofrequency
    • Publication Date:
      Date Created: 20240514 Date Completed: 20240514 Latest Revision: 20240516
    • Publication Date:
      20240516
    • Accession Number:
      PMC11089762
    • Accession Number:
      10.1186/s13063-024-08152-3
    • Accession Number:
      38741220