NCT07642167

Brief Summary

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
100

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Aug 2025

Shorter than P25 for not_applicable

Geographic Reach
1 country

2 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

August 28, 2025

Completed
7 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 12, 2026

Completed
21 days until next milestone

Study Completion

Last participant's last visit for all outcomes

April 2, 2026

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

June 8, 2026

Completed
3 days until next milestone

First Posted

Study publicly available on registry

June 11, 2026

Completed
Last Updated

June 11, 2026

Status Verified

September 1, 2025

Enrollment Period

7 months

First QC Date

June 8, 2026

Last Update Submit

June 8, 2026

Conditions

Keywords

Chronic CoccygodyniaCoccygodyniaGanglion Impar BlockOsteopathic Manual TherapyChronic PainFunctional DisabilityRehabilitationDisability EvaluationNumerical Rating ScaleOswestry Disability IndexRandomized Controlled TrialPain Management

Outcome Measures

Primary Outcomes (1)

  • Change in Oswestry Disability Index (ODI) Score

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

    Baseline and 3 months

Secondary Outcomes (1)

  • Change in Numeric Rating Scale (NRS) Pain Score

    Baseline, 3 weeks, and 3 months

Study Arms (2)

Osteopathic Manual Therapy

EXPERIMENTAL

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

Ganglion Impar Block

ACTIVE COMPARATOR

Participants received a fluoroscopy-guided ganglion impar block with local anesthetic and corticosteroid injection.

Procedure: Ganglion Impar Block

Interventions

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

Ganglion Impar Block

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

Osteopathic Manual Therapy

Eligibility Criteria

Age18 Years - 75 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

İstanbul atlas university

Istanbul, Istanbul, Turkey (Türkiye)

Location

İstanbul atlas university

Istanbul, Kadiköy, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Chronic PainAgnosia

Condition Hierarchy (Ancestors)

PainNeurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and SymptomsPerceptual DisordersNeurobehavioral ManifestationsNervous System Diseases

Study Officials

  • mert sancar, MD

    Istanbul Atlas University Faculty of Medicine

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Masking Details
Due to the nature of the interventions, participant and provider blinding was not feasible.
Purpose
TREATMENT
Intervention Model
PARALLEL
Model Details: Participants with chronic coccygodynia were randomly assigned in a 1:1 ratio to either osteopathic manual therapy (OMT) or ganglion impar block (GIB). Outcomes were assessed at baseline, 3 weeks, and 3 months.
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

June 8, 2026

First Posted

June 11, 2026

Study Start

August 28, 2025

Primary Completion

March 12, 2026

Study Completion

April 2, 2026

Last Updated

June 11, 2026

Record last verified: 2025-09

Data Sharing

IPD Sharing
Will not share

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

Locations