Chronic CoccygodyniaCOCCY-OMTNCT07642167
Osteopathic Manual Therapy Versus Ganglion Impar Block for Chronic Coccygodynia
A study testing Osteopathic Manual Therapy and Ganglion Impar Block in people with Chronic Coccygodynia, run by Atlas University at 2 sites in Turkey (Türkiye).
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Chronic Coccygodynia
- What is being tested?
- Osteopathic Manual Therapy and Ganglion Impar Block
- Type of treatment
- Injection or infusion, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 100 participants
- Where
- 2 sitesTurkey (Türkiye)
- Study dates
- 28 Aug 2025to 2 Apr 2026
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
2 sites in 1 country.
Turkey (Türkiye)2 sites
İstanbul atlas university
Istanbul, Istanbul
İstanbul atlas university
Istanbul, Kadiköy
About this study
Official title: 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:
Read more
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.
Read the 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.
- Conditions
- Chronic Coccygodynia
- Being tested
- Osteopathic Manual Therapy, Ganglion Impar Block
- Keywords
- Chronic Coccygodynia, Coccygodynia, Ganglion Impar Block, Osteopathic Manual Therapy, Chronic Pain, Functional Disability, Rehabilitation, Disability Evaluation, Numerical Rating Scale, Oswestry Disability Index, Randomized Controlled Trial, Pain Management
- Medical subject headings
- Chronic Pain, Agnosia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Osteopathic Manual TherapyProcedure or surgery
A 6-week osteopathic manual therapy program including coccygeal mobilization, levator ani muscle techniques, myofascial release, and neural stretching exercises.
Ganglion Impar BlockProcedure or surgery
A fluoroscopy-guided ganglion impar block performed with local anesthetic and corticosteroid injection for pain management in chronic coccygodynia.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Procedure: Osteopathic Manual Therapy |
| Ganglion Impar Block | Active comparator | Participants received a fluoroscopy-guided ganglion impar block with local anesthetic and corticosteroid injection. Receives: Procedure: Ganglion Impar Block |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in Oswestry Disability Index (ODI) Score
Assessment of functional disability related to chronic coccygodynia using the Oswestry Disability Index.
Measured: Baseline and 3 months
Secondary outcomes (1)
Change in Numeric Rating Scale (NRS) Pain Score
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).
Measured: Baseline, 3 weeks, and 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Jun 2026
- Study start28 Aug 2025
- Primary completion12 Mar 2026
- Study completion2 Apr 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Chronic CoccygodyniaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- 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.
- Masking
- None (open label)
- Enrolment
- 100 participants (actual)
Sponsor and investigators
- Lead sponsor
- Atlas University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- mert sancar, MD, Principal investigator, Istanbul Atlas University Faculty of Medicine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07642167
- Sponsor's protocol ID
- COCCY-OMT-GIB-2025
- Other IDs
- 2025/03-03
- Acronym
- COCCY-OMT
- Status last verified
- Sep 2025
- First submitted
- 8 Jun 2026
- Last updated
- 11 Jun 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Individual participant data will not be made publicly available due to privacy and confidentiality considerations.
Study at a glance
From the registry record, last updated by the sponsor on 11 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison of Osteopathic Manual Therapy and Ganglion Impar Block in Patients With Chronic Coccygodynia: A Prospective Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT07642167
- Acronym / sponsor ID
- COCCY-OMT / COCCY-OMT-GIB-2025
- Conditions
- Chronic Coccygodynia
- Keywords
- Chronic Coccygodynia, Coccygodynia, Ganglion Impar Block, Osteopathic Manual Therapy, Chronic Pain, Functional Disability, Rehabilitation, Disability Evaluation
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 100 participants (actual)
- Lead sponsor
- Atlas UniversityUniversity, hospital or other
- Study start
- 28 Aug 2025 (actual)
- Primary completion
- 12 Mar 2026 (actual)
- Study completion
- 2 Apr 2026 (actual)
- First posted
- 11 Jun 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- 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.
| Arm | Type | Receives |
|---|---|---|
| Osteopathic Manual Therapy | Experimental | Procedure: Osteopathic Manual TherapyParticipants 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 comparator | Procedure: Ganglion Impar BlockParticipants received a fluoroscopy-guided ganglion impar block with local anesthetic and corticosteroid injection. |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- 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
Key exclusion criteria (1 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Osteopathic Manual TherapyA 6-week osteopathic manual therapy program including coccygeal mobilization, levator ani muscle techniques, myofascial release, and neural stretching exercises. | Procedure or surgery | Osteopathic Manual Therapy |
| Ganglion Impar BlockA fluoroscopy-guided ganglion impar block performed with local anesthetic and corticosteroid injection for pain management in chronic coccygodynia. | Procedure or surgery | Ganglion Impar Block |
Primary outcome
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.
1 secondary outcome
Change in Numeric Rating Scale (NRS) Pain Score
Time frame: Baseline, 3 weeks, and 3 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Jun 2026.
- Individual participant dataSharing planned: No. Individual participant data will not be made publicly available due to privacy and confidentiality considerations.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
mert sancar, MD principal investigator
Istanbul Atlas University Faculty of Medicine
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Osteopathic Manual Therapy and Ganglion Impar Block in people with Chronic Coccygodynia, run by Atlas University at 2 sites in Turkey (Türkiye).
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 11 Jun 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in Oswestry Disability Index (ODI) Score (time frame: Baseline and 3 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 11 Jun 2026.