Dextrose prolotherapy for chronic tailbone (coccydynia) pain
The Effectiveness of Dextrose Prolotherapy in Patients With Coccydynia
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
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 40 (estimated) |
| Ages | 18 Years to 65 Years |
| Sex | All |
| Sponsor | Istanbul University Academic / other |
| Locations | 1 site (Istanbul) |
| Trial ID | NCT07552298 on ClinicalTrials.gov |
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.
Who should consider this trial
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.
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.
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 performed: 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.
Eligibility criteria
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 this trial is running
Istanbul
- 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
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.