CoccydyniaCOCCY-OMT-GIBNCT07426497
Osteopathic Manual Therapy vs Ganglion Impar Block for Chronic Coccydynia: A Randomized Controlled Trial
A study testing Osteopathic Manual Therapy and Ganglion Impar Block in people with Coccydynia and Chronic Pain, run by Istanbul Medeniyet University at 1 site in Turkey (Türkiye).
Trial summary
Chronic coccydynia is a condition characterized by persistent pain in the coccyx region that can significantly impair sitting tolerance, daily activities, and quality of life. Various conservative and interventional treatment options have been described, including manual therapy techniques and ganglion impar block. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Coccydynia, Chronic Pain, Coccygodynia
- What is being tested?
- Osteopathic Manual Therapy and Ganglion Impar Block
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 105 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 28 Feb 2026to 1 Aug 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 ≥3 months
- Baseline NRS ≥4
- ODI ≥20
- Failure of prior conservative treatment
- Imaging excludes fracture, infection, or malignancy
- Ability to provide written informed consent
Who cannot join
- Acute coccygodynia
- Prior spinal or coccygeal surgery
- Malignancy
- Pelvic fracture
- Pregnancy
- Coagulation disorder
- Severe psychiatric disease
- Prior osteopathic manual therapy or ganglion impar block
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site
Medicana Zincirlikuyu Hospital
Istanbul, Sisli, 34394
About this study
Official title: Comparison of Osteopathic Manual Therapy and Ganglion Impar Block in Patients With Chronic Coccydynia
Chronic coccydynia is a condition characterized by persistent pain in the coccyx region that can significantly impair sitting tolerance, daily activities, and quality of life. Various conservative and interventional treatment options have been described, including manual therapy techniques and ganglion impar block. However, the comparative effectiveness of these approaches remains unclear.
The aim of this randomized controlled study is to compare the effects of osteopathic manual therapy and ganglion impar block on pain intensity and functional disability in patients with chronic coccydynia. Participants will be randomly assigned to one of the two treatment groups. Pain severity will be assessed using the Numeric Rating Scale (NRS), and functional status will be evaluated with the Oswestry Disability Index (ODI) at baseline, week 3, and month 3.
The results of this study are expected to provide evidence regarding the relative effectiveness of these two commonly used treatment methods and to guide clinicians in selecting appropriate management strategies for patients with chronic coccydynia.
Read the detailed description
Chronic coccydynia is a multifactorial pain syndrome affecting the coccygeal region and is often associated with trauma, prolonged sitting, obesity, or idiopathic causes. Patients frequently report severe localized pain that worsens with sitting and transitions from sitting to standing. Conservative treatment options include physical therapy modalities and manual therapy techniques, while interventional procedures such as ganglion impar block are commonly used in refractory cases.
This prospective randomized controlled trial aims to compare the clinical effectiveness of osteopathic manual therapy and ganglion impar block in patients with chronic coccydynia. Eligible patients will be randomly allocated into two groups. The osteopathic manual therapy group will receive standardized manual therapy sessions targeting pelvic alignment, sacrococcygeal mobility, and surrounding soft tissue structures. The ganglion impar block group will undergo fluoroscopy-guided ganglion impar injection performed under sterile conditions.
The outcome measures will include pain intensity assessed by the Numeric Rating Scale (NRS) and functional disability assessed by the Oswestry Disability Index (ODI). Assessments will be performed at baseline, week 3, and month 3 follow-up.
The study is conducted at Medicana Zincirlikuyu Hospital in collaboration with Istanbul Atlas University. Ethical approval has been obtained from the Istanbul Atlas University Clinical Research Ethics Committee. The findings of this trial will contribute to the evidence base regarding non-surgical management options for chronic coccydynia.
- Conditions
- Coccydynia, Chronic Pain, Coccygodynia
- Being tested
- Osteopathic Manual Therapy, Ganglion Impar Block
- Keywords
- Chronic coccydynia, Ganglion impar block, Osteopathic manual therapy, Coccyx pain, Manual therapy, Interventional pain, Numeric Rating Scale
- Medical subject headings
- Chronic Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Osteopathic Manual TherapyProcedure or surgery
Osteopathic manual therapy was applied to the sacrococcygeal region. Techniques included myofascial release, ligamentous tension balancing, and gentle mobilization. Treatment was performed once weekly for three consecutive weeks by a certified practitioner.
Ganglion Impar BlockProcedure or surgery
A single ganglion impar block was performed under fluoroscopic guidance using local anesthetic combined with corticosteroid. The procedure was carried out under sterile conditions without additional manual therapy.
| Study group | Role | What they receive |
|---|---|---|
| Osteopathic Manual Therapy | Experimental | Participants received osteopathic manual therapy targeting the coccygeal and sacrococcygeal region. Techniques included myofascial release, ligamentous tension balancing, and gentle mobilization. Treatment was applied once weekly for 3 weeks. Receives: Procedure: Osteopathic Manual Therapy |
| Ganglion Impar Block | Experimental | Participants received a single ganglion impar block performed under fluoroscopic guidance using local anesthetic with corticosteroid. No additional manual therapy was applied. Receives: Procedure: Ganglion Impar Block |
What is being measured
The primary outcome is the main question the study is designed to answer.
Oswestry Disability Index (ODI) change at 3 months after treatment completion
Change in functional disability measured using the Oswestry Disability Index (ODI), scored from 0 to 100, with higher scores indicating greater disability. Change from baseline to 3 months after treatment completion is compared between groups. Treatment completion is defined as the last session of the three-session osteopathic manual therapy (OMT) protocol or the single ganglion impar block (GIB) procedure, according to treatment allocation.
Measured: Baseline and 3 months after treatment completion
Oswestry Disability Index (ODI) change at week 3
Change in functional disability measured using the Oswestry Disability Index (ODI), scored from 0 to 100, with higher scores indicating greater disability. Change from baseline to week 3 is compared between groups. The week-3 assessment coincides with completion of the three-session osteopathic manual therapy (OMT) protocol and occurs approximately 3 weeks after the single ganglion impar block (GIB) procedure.
Measured: Baseline and week 3
Numeric Rating Scale (NRS-11) pain change at week 3
Change in pain intensity measured using the 11-point Numeric Rating Scale (NRS-11), scored from 0 (no pain) to 10 (worst imaginable pain), with higher scores indicating greater pain intensity. Change from baseline to week 3 is compared between groups. The week-3 assessment coincides with completion of the three-session osteopathic manual therapy (OMT) protocol and occurs approximately 3 weeks after the single ganglion impar block (GIB) procedure.
Measured: Baseline and week 3
Numeric Rating Scale (NRS-11) pain change at 3 months after treatment completion
Change in pain intensity measured using the 11-point Numeric Rating Scale (NRS-11), scored from 0 (no pain) to 10 (worst imaginable pain), with higher scores indicating greater pain intensity. Change from baseline to 3 months after treatment completion is compared between groups. Treatment completion is defined as the last session of the three-session osteopathic manual therapy (OMT) protocol or the single ganglion impar block (GIB) procedure, according to treatment allocation.
Measured: Baseline and 3 months after treatment completion
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Feb 2026
- Study start28 Feb 2026
- Primary completion16 Jul 2026
- Study completion1 Aug 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for CoccydyniaStudies 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
- Masking
- None (open label)
- Enrolment
- 105 participants (actual)
Sponsor and investigators
- Lead sponsor
- Istanbul Medeniyet University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Bilinç Doğruöz Karatekin, Istanbul Medeniyet University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07426497
- Sponsor's protocol ID
- COCCY-OMT-GIB-2026
- Acronym
- COCCY-OMT-GIB
- Status last verified
- Aug 2026
- First submitted
- 16 Feb 2026
- Last updated
- 20 Oct 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 20 Oct 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 Coccydynia
- ClinicalTrials.gov ID
- NCT07426497
- Acronym / sponsor ID
- COCCY-OMT-GIB / COCCY-OMT-GIB-2026
- Conditions
- Coccydynia, Chronic Pain, Coccygodynia
- Keywords
- Chronic coccydynia, Ganglion impar block, Osteopathic manual therapy, Coccyx pain, Manual therapy, Interventional pain, Numeric Rating Scale
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 105 participants (actual)
- Lead sponsor
- Istanbul Medeniyet UniversityUniversity, hospital or other
- Study start
- 28 Feb 2026 (actual)
- Primary completion
- 16 Jul 2026 (actual)
- Study completion
- 1 Aug 2026 (actual)
- First posted
- 23 Feb 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.
Chronic coccydynia is a condition characterized by persistent pain in the coccyx region that can significantly impair sitting tolerance, daily activities, and quality of life. Various conservative and interventional treatment options have been described, including manual therapy techniques and ganglion impar block. However, the comparative effectiveness of these approaches remains unclear.
The aim of this randomized controlled study is to compare the effects of osteopathic manual therapy and ganglion impar block on pain intensity and functional disability in patients with chronic coccydynia. Participants will be randomly assigned to one of the two treatment groups. Pain severity will be assessed using the Numeric Rating Scale (NRS), and functional status will be evaluated with the Oswestry Disability Index (ODI) at baseline, week 3, and month 3.
The results of this study are expected to provide evidence regarding the relative effectiveness of these two commonly used treatment methods and to guide clinicians in selecting appropriate management strategies for patients with chronic coccydynia.
Detailed description
Chronic coccydynia is a multifactorial pain syndrome affecting the coccygeal region and is often associated with trauma, prolonged sitting, obesity, or idiopathic causes. Patients frequently report severe localized pain that worsens with sitting and transitions from sitting to standing. Conservative treatment options include physical therapy modalities and manual therapy techniques, while interventional procedures such as ganglion impar block are commonly used in refractory cases.
This prospective randomized controlled trial aims to compare the clinical effectiveness of osteopathic manual therapy and ganglion impar block in patients with chronic coccydynia. Eligible patients will be randomly allocated into two groups. The osteopathic manual therapy group will receive standardized manual therapy sessions targeting pelvic alignment, sacrococcygeal mobility, and surrounding soft tissue structures. The ganglion impar block group will undergo fluoroscopy-guided ganglion impar injection performed under sterile conditions.
The outcome measures will include pain intensity assessed by the Numeric Rating Scale (NRS) and functional disability assessed by the Oswestry Disability Index (ODI). Assessments will be performed at baseline, week 3, and month 3 follow-up.
The study is conducted at Medicana Zincirlikuyu Hospital in collaboration with Istanbul Atlas University. Ethical approval has been obtained from the Istanbul Atlas University Clinical Research Ethics Committee. The findings of this trial will contribute to the evidence base regarding non-surgical management options for chronic coccydynia.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Osteopathic Manual Therapy | Experimental | Procedure: Osteopathic Manual TherapyParticipants received osteopathic manual therapy targeting the coccygeal and sacrococcygeal region. Techniques included myofascial release, ligamentous tension balancing, and gentle mobilization. Treatment was applied once weekly for 3 weeks. |
| Ganglion Impar Block | Experimental | Procedure: Ganglion Impar BlockParticipants received a single ganglion impar block performed under fluoroscopic guidance using local anesthetic with corticosteroid. No additional manual therapy was applied. |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- Age 18-75 years
- Chronic coccygodynia ≥3 months
- Baseline NRS ≥4
- ODI ≥20
- Failure of prior conservative treatment
Key exclusion criteria (8 listed)
- Acute coccygodynia
- Prior spinal or coccygeal surgery
- Malignancy
- Pelvic fracture
- Pregnancy
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 TherapyOsteopathic manual therapy was applied to the sacrococcygeal region. Techniques included myofascial release, ligamentous tension balancing, and gentle mobilization. Treatment was performed once weekly for three consecutive weeks by a certified practitioner. | Procedure or surgery | Osteopathic Manual Therapy |
| Ganglion Impar BlockA single ganglion impar block was performed under fluoroscopic guidance using local anesthetic combined with corticosteroid. The procedure was carried out under sterile conditions without additional manual therapy. | Procedure or surgery | Ganglion Impar Block |
Primary outcome
Oswestry Disability Index (ODI) change at 3 months after treatment completion
Time frame: Baseline and 3 months after treatment completion
Change in functional disability measured using the Oswestry Disability Index (ODI), scored from 0 to 100, with higher scores indicating greater disability. Change from baseline to 3 months after treatment completion is compared between groups. Treatment completion is defined as the last session of the three-session osteopathic manual therapy (OMT) protocol or the single ganglion impar block (GIB) procedure, according to treatment allocation.
Oswestry Disability Index (ODI) change at week 3
Time frame: Baseline and week 3
Change in functional disability measured using the Oswestry Disability Index (ODI), scored from 0 to 100, with higher scores indicating greater disability. Change from baseline to week 3 is compared between groups. The week-3 assessment coincides with completion of the three-session osteopathic manual therapy (OMT) protocol and occurs approximately 3 weeks after the single ganglion impar block (GIB) procedure.
Numeric Rating Scale (NRS-11) pain change at week 3
Time frame: Baseline and week 3
Change in pain intensity measured using the 11-point Numeric Rating Scale (NRS-11), scored from 0 (no pain) to 10 (worst imaginable pain), with higher scores indicating greater pain intensity. Change from baseline to week 3 is compared between groups. The week-3 assessment coincides with completion of the three-session osteopathic manual therapy (OMT) protocol and occurs approximately 3 weeks after the single ganglion impar block (GIB) procedure.
Numeric Rating Scale (NRS-11) pain change at 3 months after treatment completion
Time frame: Baseline and 3 months after treatment completion
Change in pain intensity measured using the 11-point Numeric Rating Scale (NRS-11), scored from 0 (no pain) to 10 (worst imaginable pain), with higher scores indicating greater pain intensity. Change from baseline to 3 months after treatment completion is compared between groups. Treatment completion is defined as the last session of the three-session osteopathic manual therapy (OMT) protocol or the single ganglion impar block (GIB) procedure, according to treatment allocation.
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 20 Oct 2026.
- Individual participant dataSharing planned: No
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site 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 Coccydynia and Chronic Pain, run by Istanbul Medeniyet University at 1 site 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 7 inclusion and 8 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 20 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site 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?
Oswestry Disability Index (ODI) change at 3 months after treatment completion (time frame: Baseline and 3 months after treatment completion). The study lists 4 primary outcomes in all. 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 20 Oct 2026.