NCT06315244

Perforating Cutaneous Nerve Injection Efficacy in Chronic Coccydynia: A Randomized, Double-Blind Study

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

• Status: Unknown
• Phase: Phase 2 / Phase 3
• Study type: Interventional
• Enrollment: 40 (estimated)
• Sponsor: Sisli Hamidiye Etfal Training and Research Hospital · Academic / Other
• Sex: All
• Age: 18 Years – 50 Years
• Healthy volunteers: Not accepted

Summary

Interventions targeting the perforating cutaneous nerve are relatively new to the literature, with a safe side-effect profile but lacking high-quality studies. Their effectiveness remains at the level of case presentations. According to the hypothesis expressed in these publications, coccydynia might be an overlooked cause due to the compression of the perforating cutaneous nerve where it pierces the sacrotuberous ligament and becomes superficial. Ultimately, it is hypothesized that injection of dextrose into this ligament and the sensory area of this nerve will resolve these symptoms due to nerve entrapment, similar to other entrapment neuropathies treated with 5% dextrose, like carpal tunnel syndrome.

Conditions

• Coccyx Disorder
• Coccyx Injury

Interventions

Type	Name	Description
PROCEDURE	US Guided Perineural Injection and Neuroprolotherapy	Participants will receive an ultrasound-guided injection of a solution into the sacrotuberous ligament and the sensory innervation area of the perforating cutaneous nerve.

Timeline

• Start date: 2024-04-01
• Primary completion: 2024-07-01
• Completion: 2024-10-01
• First posted: 2024-03-18
• Last updated: 2024-03-18

Locations

1 site across 1 country: Turkey (Türkiye)