Effectiveness of Perforating Cutaneous Nerve Injection in Patients With Chronic Coccydynia: A Prospective, Randomized, Placebo-Controlled, Double-Blind Study
Status: Recruiting
Location: See location...
Intervention Type: Procedure
Study Type: Interventional
Study Phase: Phase 2/Phase 3
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.
Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Maximum Age: 50
Healthy Volunteers: f
View:
• Age between 18 and 50 years.
• Chronic coccyx pain (≥3 months).
• Pain Visual Analogue Scale (VAS) score ≥4.
• Pain not alleviated by first-line treatment (physical therapy/oral analgesic therapy + sitting cushion).
Locations
Other Locations
Turkey
Sisli Hamidiye Etfal Training and Research Hospital
RECRUITING
Istanbul
Contact Information
Primary
Enes Efe Is, MD
enefeis@gmail.com
+903735000
Time Frame
Start Date:2024-04-01
Estimated Completion Date:2024-10-01
Participants
Target number of participants:40
Treatments
Experimental: %5 Dextrose Injection Group
Participants in this arm will receive an ultrasound-guided injection of 5% dextrose solution into the sacrotuberous ligament and the sensory innervation area of the perforating cutaneous nerve. The intervention aims to alleviate symptoms of chronic coccydynia by reducing nerve entrapment. Participants will continue their existing physical therapy/medical treatment regimen throughout the study.
Placebo_comparator: Placebo Injection Group
Participants in this arm will receive an ultrasound-guided injection of a placebo solution (saline) into the same anatomical region as the experimental group. This arm serves as a control to evaluate the efficacy of the dextrose injection in treating chronic coccydynia symptoms. Participants will continue their existing physical therapy/medical treatment regimen throughout the study.