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OpenTrials
Completed

NCT Number: NCT07642167

Osteopathic Manual Therapy Versus Ganglion Impar Block for Chronic Coccygodynia

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.

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Key information

Age range

18 year–75 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

İstanbul atlas university, Istanbul, Turkey (Türkiye)

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About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Osteopathic Manual Therapy

Procedure

A 6-week osteopathic manual therapy program including coccygeal mobilization, levator ani muscle techniques, myofascial release, and neural stretching exercises.

Ganglion Impar Block

Procedure

A fluoroscopy-guided ganglion impar block performed with local anesthetic and corticosteroid injection for pain management in chronic coccygodynia.

Primary outcomes

  1. Change in Oswestry Disability Index (ODI) Score

    Time frame: Baseline and 3 months

    Assessment of functional disability related to chronic coccygodynia using the Oswestry Disability Index.

Secondary outcomes

  1. Change in Numeric Rating Scale (NRS) Pain Score

    Time frame: 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).

Sponsors and collaborators

Lead sponsor

Atlas University

Other

Registry information

Official study title

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

Acronym: COCCY-OMT

Important dates

Study start
2025
Primary completion
2026
Study completion
2026
First posted
Jun 11, 2026
Registry last updated
Jun 11, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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