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Osteopathic Manual Therapy Versus Ganglion Impar Block for Chronic Coccygodynia (COCCY-OMT)

2026年6月8日 更新者：Atlas University

Comparison of Osteopathic Manual Therapy and Ganglion Impar Block in Patients With Chronic Coccygodynia: A Prospective Randomized Controlled Trial

The goal of this clinical trial is to compare two treatment methods for chronic coccygodynia (tailbone pain) in adults. The study aims to determine which treatment provides better pain relief and functional improvement.

The main questions it aims to answer are:

Does osteopathic manual therapy reduce pain and disability in people with chronic coccygodynia?

Does ganglion impar block reduce pain and disability in people with chronic coccygodynia?

Which treatment provides more sustained improvement during follow-up?

Researchers will compare osteopathic manual therapy with ganglion impar block to evaluate their effects on pain, function, quality of life, and patient satisfaction.

Participants will:

Be randomly assigned to one of the two treatment groups.

Receive either osteopathic manual therapy or ganglion impar block.

Complete pain, disability, neuropathic pain, and quality-of-life assessments before treatment and during follow-up visits.

Attend follow-up evaluations at 3 weeks and 3 months after treatment.

研究概览

地位

完全的

条件

干预/治疗

详细说明

Chronic coccygodynia is persistent pain in the tailbone region that can significantly affect daily activities and quality of life. Common treatments include physical therapy, manual therapy techniques, injections, and surgical procedures. However, evidence directly comparing osteopathic manual therapy and ganglion impar block remains limited.

This prospective randomized controlled trial will compare the effectiveness of osteopathic manual therapy and ganglion impar block in adults with chronic coccygodynia lasting at least three months and not responding adequately to conservative treatment.

Eligible participants will be randomly assigned to one of two groups. The osteopathic manual therapy group will receive a structured treatment program including manual mobilization and soft tissue techniques. The ganglion impar block group will receive a fluoroscopy-guided ganglion impar injection.

Outcomes will be assessed using pain intensity, disability, neuropathic pain, quality of life, and patient satisfaction measures. Evaluations will be performed at baseline, 3 weeks, and 3 months after treatment.

The primary objective is to compare changes in pain and disability between the two treatment groups. Secondary objectives include comparison of neuropathic pain symptoms, quality of life, and patient satisfaction.

研究类型

介入性

注册 (实际的)

100

阶段

  • 不适用

联系人和位置

本节提供了进行研究的人员的详细联系信息，以及有关进行该研究的地点的信息。

学习地点

  • 土耳其（türkiye）
    • Istanbul
      • Istanbul、Istanbul、土耳其（türkiye）
        • Istanbul Atlas University
    • Kadiköy
      • Istanbul、Kadiköy、土耳其（türkiye）
        • Istanbul Atlas University

参与标准

研究人员寻找符合特定描述的人，称为资格标准。这些标准的一些例子是一个人的一般健康状况或先前的治疗。

资格标准

适合学习的年龄

  • 成人
  • 年长者

接受健康志愿者

不

描述

Inclusion Criteria:

Age 18-75 years Chronic coccygodynia persisting for at least 3 months Unresponsive to previous conservative treatment Baseline NRS score ≥4 Baseline ODI score ≥20 Written informed consent

Exclusion Criteria:

Acute coccygodynia Previous coccygeal or spinal surgery Malignancy Pelvic fracture Pregnancy Coagulation disorders Severe psychiatric disease Previous osteopathic manual therapy or ganglion impar block Structural pathology identified on MRI or dynamic radiography

学习计划

本节提供研究计划的详细信息，包括研究的设计方式和研究的衡量标准。

研究是如何设计的？

设计细节

  • 主要用途：治疗
  • 分配：随机化
  • 介入模型：并行分配
  • 屏蔽：无（打开标签）

武器和干预

参与者组/臂
干预/治疗
实验性的：Osteopathic Manual Therapy
Participants received a 6-week osteopathic manual therapy program including coccygeal mobilization, levator ani muscle techniques, myofascial release, and neural stretching exercises.
程序：Osteopathic Manual Therapy
A 6-week osteopathic manual therapy program including coccygeal mobilization, levator ani muscle techniques, myofascial release, and neural stretching exercises.
有源比较器：Ganglion Impar Block
Participants received a fluoroscopy-guided ganglion impar block with local anesthetic and corticosteroid injection.
程序：Ganglion Impar Block
A fluoroscopy-guided ganglion impar block performed with local anesthetic and corticosteroid injection for pain management in chronic coccygodynia.

研究衡量的是什么？

主要结果指标

结果测量
措施说明
大体时间
Change in Oswestry Disability Index (ODI) Score
大体时间：Baseline and 3 months
Assessment of functional disability related to chronic coccygodynia using the Oswestry Disability Index.
Baseline and 3 months

次要结果测量

结果测量
措施说明
大体时间
Change in Numeric Rating Scale (NRS) Pain Score
大体时间：Baseline, 3 weeks, and 3 months
Assessment of pain intensity using the Numeric Rating Scale (NRS). Participants rate their pain on a scale from 0 (no pain) to 10 (worst possible pain).
Baseline, 3 weeks, and 3 months

合作者和调查者

在这里您可以找到参与这项研究的人员和组织。

赞助

Atlas University

调查人员

  • 首席研究员：mert sancar, MD、Istanbul Atlas University Faculty of Medicine

研究记录日期

这些日期跟踪向 ClinicalTrials.gov 提交研究记录和摘要结果的进度。研究记录和报告的结果由国家医学图书馆 (NLM) 审查，以确保它们在发布到公共网站之前符合特定的质量控制标准。

研究主要日期

学习开始 (实际的)

2025年8月28日

初级完成 (实际的)

2026年3月12日

研究完成 (实际的)

2026年4月2日

研究注册日期

首次提交

2026年6月8日

首先提交符合 QC 标准的

2026年6月8日

首次发布 (实际的)

2026年6月11日

研究记录更新

最后更新发布 (实际的)

2026年6月11日

上次提交的符合 QC 标准的更新

2026年6月8日

最后验证

2025年9月1日

更多信息

与本研究相关的术语

关键字

其他相关的 MeSH 术语

其他研究编号

  • COCCY-OMT-GIB-2025
  • 2025/03-03 (其他标识符：Istanbul Atlas University Clinical Research Ethics Committee)

计划个人参与者数据 (IPD)

计划共享个人参与者数据 (IPD)？

不

IPD 计划说明

Individual participant data will not be made publicly available due to privacy and confidentiality considerations.

药物和器械信息、研究文件

研究美国 FDA 监管的药品

不

研究美国 FDA 监管的设备产品

不

此信息直接从 clinicaltrials.gov 网站检索，没有任何更改。如果您有任何更改、删除或更新研究详细信息的请求，请联系 register@clinicaltrials.gov. clinicaltrials.gov 上实施更改，我们的网站上也会自动更新.

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