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

NCT06315244 | Recruiting Phase 2

• 1 other identifier: 2558
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 1

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.

Conditions

Coccyx Disorder; Coccyx Injury

Outcome Measures

Primary Outcomes (1)

• Effectiveness of Perforating Cutaneous Nerve Injection

  To 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.

  Baseline, 2 weeks, 1 month, and 3 months post-treatment

Secondary Outcomes (2)

• Change in Pressure Pain Threshold

  Baseline, 2 weeks, 1 month, and 3 months post-treatment

• Change in Quality of Life

  Baseline, 2 weeks, 1 month, and 3 months post-treatment

Study Arms (2)

%5 Dextrose Injection Group

EXPERIMENTAL

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.

Procedure: US Guided Perineural Injection and Neuroprolotherapy

Placebo Injection Group

PLACEBO COMPARATOR

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.

Procedure: US Guided Perineural Injection and Neuroprolotherapy

Interventions

US Guided Perineural Injection and Neuroprolotherapy PROCEDURE

Participants will receive an ultrasound-guided injection of a solution into the sacrotuberous ligament and the sensory innervation area of the perforating cutaneous nerve.

%5 Dextrose Injection Group; Placebo Injection Group

Eligibility Criteria

• Age: 18 Years - 50 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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).

You may not qualify if:

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

Sponsors & Collaborators

• Sisli Hamidiye Etfal Training and Research Hospital: lead

Study Sites (1)

Sisli Hamidiye Etfal Training and Research Hospital

Istanbul, 34371, Turkey (Türkiye)

RECRUITING

Study Officials

• Julide Oncu Alptekin, Professor

  Sisli Hamidiye Training and Research Hospital

  STUDY CHAIR

Central Study Contacts

Enes Efe Is, MD

CONTACT

+903735000; enefeis@gmail.com

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: MD

Study Record Dates

• First Submitted: March 11, 2024
• First Posted: March 18, 2024
• Study Start: April 1, 2024
• Primary Completion: July 1, 2024
• Study Completion: October 1, 2024
• Last Updated: March 18, 2024

Record last verified: 2024-03

Locations

TU (1)