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临床试验/NCT07642167
NCT07642167已完成不适用

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

Atlas University1 个研究点 分布在 1 个国家目标入组 100 人开始时间: 2025年8月28日最近更新:

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
100
试验地点
1

研究概览

简要总结

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.

详细描述

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.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Treatment
盲法
None

盲法说明

Due to the nature of the interventions, participant and provider blinding was not feasible.

入排标准

年龄范围
18 Years 至 75 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • 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

排除标准

  • 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

研究者

发起方
Atlas University
申办方类型
Other
责任方
Sponsor

研究点 (1)

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