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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
Recruiting
Phases
Phase 2Phase 3
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT06315244
Enrollment
40
Registered
2024-03-18
Start date
2024-04-01
Completion date
2024-10-01
Last updated
2024-03-18

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Coccyx Disorder, Coccyx Injury

Brief 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.

Interventions

PROCEDUREUS 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.

Sponsors

Sisli Hamidiye Etfal Training and Research Hospital
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
TRIPLE (Subject, Investigator, Outcomes Assessor)

Eligibility

Sex/Gender
ALL
Age
18 Years to 50 Years
Healthy volunteers
No

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).

Design outcomes

Primary

MeasureTime frameDescription
Effectiveness of Perforating Cutaneous Nerve InjectionBaseline, 2 weeks, 1 month, and 3 months post-treatmentTo evaluate the effectiveness of perforating cutaneous nerve injection in reducing pain in patients with chronic coccydynia. Pain levels will be assessed using the Visual Analogue Scale (VAS) during sitting, movement and rest.

Secondary

MeasureTime frameDescription
Change in Pressure Pain ThresholdBaseline, 2 weeks, 1 month, and 3 months post-treatmentAssessment of the pressure pain threshold using an algometer.
Change in Quality of LifeBaseline, 2 weeks, 1 month, and 3 months post-treatmentAssessment of quality of life using the EuroQoL questionnaire.

Countries

Turkey (Türkiye)

Contacts

Primary ContactEnes Efe Is, MD
enefeis@gmail.com+903735000

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026