Evidence map›Paper›PMID 38741220›Full record

ArticleTrials2024

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

Jiao Ran, Fan Lu, Le Xu, Yu Du, Li Liu, Tao Qi, Xiaoli Zhou, Yulin Zhang, Dong Liu, Rurong Wang and 1 more

Abstract readClinical Trial Protocol
In one paragraph

Article in Trials, 2024. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 2 papers, 1 of them a synthesis that pooled it.

0numbers the graph read from it
0cells of the map it votes in
2citing papers in PubMed, 1 pooled it
–field-weighted citation impact
1 · What the graph read from it

What it found

Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.

The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.

2 · The registry

The trial behind it

Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.

Neither the registry nor the abstract names a trial number. If this is a trial report, that itself is worth knowing.

3 · Its place in the literature

Who cites it

2 citing papers in PubMed, 1 synthesis or guideline pooled it.

  1. Pooled it
  2. Review
4 · The record

Corrections and comments

PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.

5 · Who and what money

Authors and funding

11 authors.

Jiao Ran *Department of Anesthesiology, West China Hospital, Sichuan University, Chengdu, China.
Fan Lu *Department of Pain Medicine, West China Hospital, Sichuan University, Chengdu, China.
Le XuDepartment of Anesthesiology, West China Hospital, Sichuan University, Chengdu, China.
Yu DuDepartment of Anesthesiology, Sichuan Provincial People's Hospital, University of Electronic Science and Technology of China, No. 32, West Section 2, 1St Ring Road, Qingyang District, Chengdu City, Sichuan Province, China.
Li LiuSichuan Science City Hospital, No. 64 Mianshan Road, Youxian District, Mianyang City, Sichuan Province, China.
Tao QiDepartment of Pain Management, The Affiliated Hospital of Chengdu University of Traditional Chinese Medicine, No. 39, 12 Qiao Road, Jinniu District, Chengdu, China.
Xiaoli ZhouNo.903 Hospital, the Affiliated Hospital of Chengdu Medical College, No. 9 Huafeng New Village, Middle Section of Taiping Road, Jiangyou City, Mianyang City, China.
Yulin ZhangDepartment of Pain Management, The Second Clinical College of North Sichuan Medical College, Nanchong Central Hospital (Beijing Anzhen Hospital Nanchong Hospital), No. 97, Renmin South Road, Shunqing District, Nanchong, 637000, Sichuan, China.
Dong LiuDepartment of Pain Management, Chengdu Second People's Hospital, No. 10 Qingyunnan Street, Jinjiang District, Chengdu, China.
Rurong WangDepartment of Anesthesiology, West China Hospital, Sichuan University, Chengdu, China. wangrurong@scu.edu.cn.ORCID http://orcid.org/0000-0002-9213-3104
Xuehan LiDepartment of Anesthesiology, West China Hospital, Sichuan University, Chengdu, China. xuehanli@scu.edu.cn.

Funding

the National Key Research and Development Program of China 2021YF2009105West China Hospital, Sichuan University No. 2022HXFH035
6 · The paper itself

Abstract

backgroundPudendal 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.

methodsThis 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 registrationChinese Clinical Trial Registry (ChiCTR2200061800).

Indexed as

Pain MeasurementPudendal NervePudendal NeuralgiaPulsed Radiofrequency TreatmentRandomized Controlled Trials as TopicAdultAgedAutonomic Nerve BlockCombined Modality TherapyFemaleHumansMaleMiddle AgedPain ManagementTreatment OutcomeYoung AdultGanglion impar blockPudendal nerve blockPudendal neuralgiaPulsed radiofrequency

Identifiers

PMID38741220
PMCPMC11089762

What OpenQuestion holds

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LicenceCC BY
Read underepoch 390

Registered trials

None linked

Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.