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NCT06315244
Perforating Cutaneous Nerve Injection Efficacy in Chronic Coccydynia: A Randomized, Double-Blind Study
Phase 2, PHASE3 trial testing US Guided Perineural Injection and Neuroprolotherapy in Coccyx Disorder in 40 participants. Status unknown.
1 July 2024
Quick facts
| Lead sponsor | Sisli Hamidiye Etfal Training and Research Hospital |
|---|---|
| Phase | Phase 2, PHASE3 |
| Status | Status unknown |
| Study type | INTERVENTIONAL |
| Allocation | randomized |
| Design | parallel |
| Masking | triple |
| Primary purpose | treatment |
| Enrollment | 40 |
| Start date | 1 April 2024 |
| Primary completion | 1 July 2024 |
| Estimated completion | 1 October 2024 |
| Sites | 1 location across Turkey (Türkiye) |
Drugs / interventions tested
- US Guided Perineural Injection and Neuroprolotherapy
Conditions studied
- Coccyx Disorder — all drugs for Coccyx Disorder →
- Coccyx Injury — all drugs for Coccyx Injury →
Sponsor
Sisli Hamidiye Etfal Training and Research Hospital
Who can join
Adults 18 to 50, any sex, with Coccyx Disorder or Coccyx Injury. Patients with the condition only — healthy volunteers not accepted.
Sponsor's own description
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.
Publications & conference data
No peer-reviewed publications indexed yet for this trial.
Verify or expand the search:
- PubMed search for NCT06315244
- Europe PMC full search
- ASCO Meeting Library
- ESMO Meeting Library
- bioRxiv preprints
- medRxiv preprints
- Google Scholar
Related trials
Other recruiting trials for Coccyx Disorder
Currently open trials in the same condition.
- NCT06754033 — Ganglion Impar Block With Physical Therapy vs Caudal Epidural Steroid Injection With PT for Patients With Coccydynia · NA · active not recruiting
- NCT06023706 — Study Evaluating the Analgesic Efficacy of Capsaicin 8% Patches in Chronic Coccygodynia. · Phase 3 · recruiting
Other Sisli Hamidiye Etfal Training and Research Hospital trials
Trials by the same sponsor.
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- NCT07166614 — Dexmedetomidine vs Propofol in High-Risk ERCP Patients · NA · recruiting
- NCT07250243 — Turkish Validation and Reliability of the John Hopkins In-Room Independence Scale · completed
Verify against primary sources
- ClinicalTrials.gov — authoritative US registry record
- WHO ICTRP — international registry index
- EU Clinical Trials Register
- Sponsor press releases (Google)
- Trial protocol + status: ClinicalTrials.gov NCT06315244 (US National Library of Medicine, public domain)
- Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
- Sponsor: as reported to ClinicalTrials.gov by Sisli Hamidiye Etfal Training and Research Hospital
- Last refreshed: 18 March 2024
Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT06315244.
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