Dextrose prolotherapy for chronic tailbone (coccydynia) pain
Official title: The Effectiveness of Dextrose Prolotherapy in Patients With Coccydynia
Run by Istanbul University · NCT07552298 · Data updated 2026-11-12
This study will try dextrose prolotherapy injections to see if they reduce chronic tailbone pain in adults who haven't improved after six months of conservative treatment.
Quick facts
| Study type | Interventional |
|---|---|
| Ages | 18 Years to 65 Years |
| Sex | All |
| Enrollment | 40 (estimated) |
| Sponsor | Istanbul University Academic / other |
| Locations | 1 site (Istanbul) |
| Status | Recruiting |
| Started | June 15, 2025 |
| Main results expected | October 15, 2026 |
| Study ends | November 15, 2026 |
| Registry record updated | April 27, 2026 |
| Trial ID | NCT07552298 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a good fit
Adults aged 18–65 with coccygeal tenderness and coccydynia lasting more than six months who have failed at least six months of conservative treatments are ideal candidates.
✕Probably not a fit
Patients with recent coccygeal trauma or postpartum onset, active infection or lesions at the injection site, dislocation or bone pathology of the coccyx, uncontrolled diabetes, bleeding disorders, certain neurologic or rheumatologic conditions, recent coccyx injections, or severe comorbidities are unlikely to be suitable or to benefit.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
What this trial studies
In a randomized, double-blinded, controlled design, 40 adults with chronic coccydynia will be assigned by computer to receive either three sessions of dextrose prolotherapy or three sessions of a superficial saline-lidocaine injection, each given at three-week intervals alongside standard protection recommendations. Investigators will record demographic and medical history data, perform lumbar and sacroiliac tests and sacrococcygeal palpation, and measure average and maximum pain and any complications. Patients will be followed for approximately one year with periodic assessments for side effects and treatment response. Outcomes will compare pain relief and safety between the dextrose and saline-lidocaine groups.
Why it matters
Potential benefit: If effective, dextrose prolotherapy could offer a minimally invasive option for longer-lasting relief of chronic coccydynia in patients who have not responded to conservative care.
How similar studies have gone: Prolotherapy using dextrose has produced mixed but sometimes promising results in other chronic musculoskeletal pain conditions, while high-quality randomized evidence specifically for coccydynia remains limited.
Who can join: the full rules
Show full inclusion / exclusion criteria
Inclusion Criteria: * Patients with coccydynia lasting longer than 6 months, * Those unresponsive to at least 6 months of conventional conservative treatment methods, * Those with coccygeal tenderness on palpation, * Patients aged between 18 and 65 years. Exclusion Criteria: * Patients with a history of trauma within the last 3 months or postpartum coccydynia, * Those with lesions or infections at the injection site, * Those with dislocation or organic bone pathology of the coccyx observed on X-ray imaging, * Those with fecal or urinary incontinence, * Patients with poorly controlled diabetes mellitus, * Those with a history of malignancy, * Patients with a bleeding tendency (acquired or hereditary) \[INR \> 2 in patients using warfarin\], * Those with a history of myelomeningocele, * Those diagnosed with spina bifida, * Patients with rheumatologic disease, * Those who have undergone coccyx injection or ganglion block within the last 3 months, * Patients with severe comorbidities.
Where it's running
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Istanbul University Istanbul Faculty of Medicine, Department of Physical Medicine and Rehabilitation
Istanbul, Turkey (Türkiye) Recruiting
Study contacts
- Principal investigator: Ekin I Sen, Assoc.Prof. — Istanbul University Istanbul Faculty of Medicine, Department of Physical Medicine and Rehabilitation
- Study coordinator: Ekin I Sen, Assoc.Prof.
- Email: ekinozgorgu@gmail.com
- Phone: +902124142000
Similar studies
Other studies for the same condition or treatment. Recruiting studies are listed first.
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Shock Wave Therapy vs High-Intensity Laser Therapy for Tailbone Pain
This study tests whether shock wave therapy or high-intensity laser therapy reduces pain while sitting for adults with chronic tailbone pain.
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Ultrasound-guided dextrose prolotherapy for coccyx pain
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.
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Comparing two pain relief techniques for tailbone pain
This study is testing two different pain relief methods for people with chronic tailbone pain to see which one helps them feel better.
How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.