Injection treatment for chronic coccyx pain

Effectiveness of Perforating Cutaneous Nerve Injection in Patients With Chronic Coccydynia: A Prospective, Randomized, Placebo-Controlled, Double-Blind Study

This study tests whether injecting a sugar solution into a specific nerve area can help people with chronic tailbone pain feel better.

Quick facts

• Phase: Phase2; Phase3
• Study type: Interventional
• Enrollment: 40 (estimated)
• Ages: 18 Years to 50 Years
• Sex: All
• Sponsor: Sisli Hamidiye Etfal Training and Research Hospital (Academic / other)
• Locations: 1 site (Istanbul)
• Trial ID: NCT06315244 on ClinicalTrials.gov

What this trial studies

This clinical trial investigates the efficacy of injecting dextrose into the perforating cutaneous nerve area to alleviate chronic coccyx pain, known as coccydynia. The approach is based on the hypothesis that nerve entrapment at this site may contribute to the pain experienced by patients. Participants will receive ultrasound-guided perineural injections as a potential treatment option, with the study being randomized and double-blind to ensure unbiased results. The trial aims to provide high-quality evidence regarding this novel intervention.

Who should consider this trial

Good fit: Ideal candidates are adults aged 18 to 50 with chronic coccyx pain lasting at least three months and a pain score of 4 or higher.

Not a fit: Patients with recent injections, specific medical histories, or concurrent conditions affecting the coccyx may not benefit from this study.

Why it matters

Potential benefit: If successful, this treatment could significantly reduce chronic coccyx pain for patients who have not responded to conventional therapies.

How similar studies have performed: While interventions targeting the perforating cutaneous nerve are relatively new, similar approaches in treating other entrapment neuropathies have shown promise.

Eligibility criteria

Inclusion Criteria:

1. Age between 18 and 50 years.
2. Chronic coccyx pain (≥3 months).
3. Pain Visual Analogue Scale (VAS) score ≥4.
4. Pain not alleviated by first-line treatment (physical therapy/oral analgesic therapy + sitting cushion).

Exclusion Criteria:

1. Injection to the area in the last 3 months.
2. Concurrent mechanical or inflammatory low back pain.
3. Coccyx pain that started during pregnancy or postpartum.
4. History of myelomeningocele or spina bifida.
5. History of sacrococcygeal luxation or subluxation (confirmed by radiography).
6. History of coccyx fracture.
7. Concurrent neurological deficit.
8. Skin disease affecting the injection area.
9. History of malignancy.
10. Pregnancy or breastfeeding.
11. Severe coagulopathy.
12. Infection at the injection site.
13. Neurological or psychiatric diseases, including ongoing depression (Beck Depression Inventory Score \>14).

Where this trial is running

Istanbul

• Sisli Hamidiye Etfal Training and Research Hospital — Istanbul, Turkey (Recruiting)

Study contacts

• Study coordinator: Enes Efe Is, MD

Conditions Coccyx Disorder; Coccyx Injury