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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Clinical Phase

PHASE2/PHASE3

Total Enrollment

40 participants

Study Classification

INTERVENTIONAL

Study Start Date

2024-04-01

Study Completion Date

2024-10-01

Brief Summary

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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.

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Detailed Description

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Conditions

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Coccyx Disorder Coccyx Injury

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

TRIPLE

Participants Investigators Outcome Assessors

Study Groups

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%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.

Group Type EXPERIMENTAL

US Guided Perineural Injection and Neuroprolotherapy

Intervention Type 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.

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.

Group Type PLACEBO_COMPARATOR

US Guided Perineural Injection and Neuroprolotherapy

Intervention Type 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.

Interventions

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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.

Intervention Type PROCEDURE

Eligibility Criteria

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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).

Minimum Eligible Age

18 Years

Maximum Eligible Age

50 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No