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

June 8, 2026 updated by: 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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

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.

Study Type

Interventional

Enrollment (Actual)

100

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Turkey (Türkiye)
    • Istanbul
      • Istanbul, Istanbul, Turkey (Türkiye)
        • İstanbul atlas university
    • Kadiköy
      • Istanbul, Kadiköy, Turkey (Türkiye)
        • İstanbul atlas university

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: 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.
Procedure: Osteopathic Manual Therapy
A 6-week osteopathic manual therapy program including coccygeal mobilization, levator ani muscle techniques, myofascial release, and neural stretching exercises.
Active Comparator: Ganglion Impar Block
Participants received a fluoroscopy-guided ganglion impar block with local anesthetic and corticosteroid injection.
Procedure: Ganglion Impar Block
A fluoroscopy-guided ganglion impar block performed with local anesthetic and corticosteroid injection for pain management in chronic coccygodynia.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
Baseline and 3 months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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).
Baseline, 3 weeks, and 3 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Atlas University

Investigators

  • Principal Investigator: mert sancar, MD, Istanbul Atlas University Faculty of Medicine

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

August 28, 2025

Primary Completion (Actual)

March 12, 2026

Study Completion (Actual)

April 2, 2026

Study Registration Dates

First Submitted

June 8, 2026

First Submitted That Met QC Criteria

June 8, 2026

First Posted (Actual)

June 11, 2026

Study Record Updates

Last Update Posted (Actual)

June 11, 2026

Last Update Submitted That Met QC Criteria

June 8, 2026

Last Verified

September 1, 2025

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • COCCY-OMT-GIB-2025
  • 2025/03-03 (Other Identifier: Istanbul Atlas University Clinical Research Ethics Committee)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

IPD Plan Description

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

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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