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

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.

Study Overview

• Status: Recruiting
• Conditions: Coccyx Disorder; Coccyx Injury
• Intervention / Treatment: Procedure: US Guided Perineural Injection and Neuroprolotherapy

• Study Type: Interventional
• Enrollment (Estimated): 40
• Phase: Phase 2; Phase 3

Contacts and Locations

• Study Contact: Name: Enes Efe Is, MD; Phone Number: +903735000; Email: enefeis@gmail.com

Study Locations

• Turkey
  • Istanbul, Turkey, 34371
    • Recruiting
    • Sisli Hamidiye Etfal Training and Research Hospital
    • Contact: Enes Efe Is, MD; Phone Number: +902123735000; Email: enefeis@gmail.com
    • Principal Investigator: Enes Efe Is, MD

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult
• Accepts Healthy Volunteers: No

Description

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).

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Triple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
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.	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.
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.	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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change in Pressure Pain Threshold	Assessment of the pressure pain threshold using an algometer.	Baseline, 2 weeks, 1 month, and 3 months post-treatment
Change in Quality of Life	Assessment of quality of life using the EuroQoL questionnaire.	Baseline, 2 weeks, 1 month, and 3 months post-treatment

Collaborators and Investigators

• Sponsor: Sisli Hamidiye Etfal Training and Research Hospital
• Investigators: Study Chair: Julide Oncu Alptekin, Professor, Sisli Hamidiye Training and Research Hospital

Study record dates

Study Major Dates

• Study Start (Estimated): April 1, 2024
• Primary Completion (Estimated): July 1, 2024
• Study Completion (Estimated): October 1, 2024

Study Registration Dates

• First Submitted: March 11, 2024
• First Submitted That Met QC Criteria: March 11, 2024
• First Posted (Actual): March 18, 2024

Study Record Updates

• Last Update Posted (Actual): March 18, 2024
• Last Update Submitted That Met QC Criteria: March 11, 2024
• Last Verified: March 1, 2024

More Information

Terms related to this study

• Other Study ID Numbers: 2558

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No