Osteopathic Manual Therapy Versus Ganglion Impar Block for Chronic Coccygodynia
COCCY-OMT
Comparison of Osteopathic Manual Therapy and Ganglion Impar Block in Patients With Chronic Coccygodynia: A Prospective Randomized Controlled Trial
2 other identifiers
interventional
100
1 country
2
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
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for not_applicable
Started Aug 2025
Shorter than P25 for not_applicable
2 active sites
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
CompletedPrimary Completion
Last participant's last visit for primary outcome
March 12, 2026
CompletedStudy Completion
Last participant's last visit for all outcomes
April 2, 2026
CompletedFirst Submitted
Initial submission to the registry
June 8, 2026
CompletedFirst Posted
Study publicly available on registry
June 11, 2026
CompletedJune 11, 2026
September 1, 2025
7 months
June 8, 2026
June 8, 2026
Conditions
Keywords
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
EXPERIMENTALParticipants received a 6-week osteopathic manual therapy program including coccygeal mobilization, levator ani muscle techniques, myofascial release, and neural stretching exercises.
Ganglion Impar Block
ACTIVE COMPARATORParticipants received a fluoroscopy-guided ganglion impar block with local anesthetic and corticosteroid injection.
Interventions
A fluoroscopy-guided ganglion impar block performed with local anesthetic and corticosteroid injection for pain management in chronic coccygodynia.
A 6-week osteopathic manual therapy program including coccygeal mobilization, levator ani muscle techniques, myofascial release, and neural stretching exercises.
Eligibility Criteria
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
- Atlas Universitylead
Study Sites (2)
İstanbul atlas university
Istanbul, Istanbul, Turkey (Türkiye)
İstanbul atlas university
Istanbul, Kadiköy, Turkey (Türkiye)
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
mert sancar, MD
Istanbul Atlas University Faculty of Medicine
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
- 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.