Ultrasound-guided dextrose prolotherapy for coccyx pain
Evaluation of the Effectiveness of Dextrose Prolotherapy on Pain Severity and Functional Status in Patients With Coccydynia: A Prospective Study
This will test whether ultrasound-guided 15% dextrose injections can reduce pain and improve function in adults (18–75) with chronic coccydynia not helped by conservative treatments.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 30 (estimated) |
| Ages | 18 Years to 75 Years |
| Sex | All |
| Sponsor | Gaziosmanpasa Research and Education Hospital Government |
| Locations | 1 site (Istanbul) |
| Trial ID | NCT07564167 on ClinicalTrials.gov |
What this trial studies
This is a prospective, single-arm, open-label interventional study in which adults with chronic coccydynia receive ultrasound-guided injections of 15% dextrose (prolotherapy) around the coccyx. The injections aim to stimulate a controlled healing response in ligamentous and periarticular tissues thought to contribute to pain. Pain severity and functional status will be recorded before and after the intervention to track changes over time. The study enrolls patients whose symptoms have persisted for at least three months despite conservative care and excludes those with active infection, bleeding disorders, pregnancy, or allergy to the solution.
Who should consider this trial
Good fit: Adults aged 18–75 with mechanical or idiopathic coccydynia lasting ≥3 months that is refractory to conservative treatment, and who do not have infection, pregnancy, anticoagulant use, malignancy, or allergy to the proliferant.
Not a fit: Patients with coccydynia due to infection, malignancy, active local abscess, hemorrhagic diathesis, current anticoagulant therapy, pregnancy, or allergy to the dextrose solution are excluded and unlikely to benefit from this protocol.
Why it matters
Potential benefit: If successful, this treatment could offer a minimally invasive option to reduce coccyx pain and improve sitting tolerance and daily function for patients who have not responded to standard therapies.
How similar studies have performed: Prolotherapy has demonstrated benefit in some chronic mechanical musculoskeletal conditions, but high-quality evidence specific to coccydynia is limited and this application remains relatively untested.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * Age between 18 and 75 years * Pain persisting for ≥3 months and refractory to conservative treatment * Coccydynia of mechanical or idiopathic origin Exclusion Criteria: * Age \<18 years or \>75 years * Pregnancy * Allergy to the proliferant solution * Active infection * Use of anticoagulant medications * Presence of malignancy * Local abscess * Hemorrhagic diathesis * Certain types of septic arthritis * Parafunctional habits
Where this trial is running
Istanbul
- Gaziosmanpasa Research and Education Hospital — Istanbul, Turkey (Türkiye) (Recruiting)
Study contacts
- Principal investigator: Merve Dikici Yagli, M.D — Gaziosmanpasa Research and Education Hospital
- Study coordinator: Merve Dikici Yagli, M.D
- Email: mervedikici1992@gmail.com
- Phone: +905387192098
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.