Coccygeal Nerve Radiofrequency Treatment in Coccydynia

NCT ID: NCT05596448

Last Updated: 2022-10-27

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

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

60 participants

Study Classification

INTERVENTIONAL

Study Start Date

2022-10-22

Study Completion Date

2023-12-31

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

Coccydynia or coccygeal pain is a painful syndrome that affects the coccyx region. The most important etiological factors in the formation of coccidynia are; external and internal trauma. Patients with coccydynia typically complain of coccyx pain. This pain increases with prolonged sitting, bending backwards during sitting, standing for long periods of time, and standing up after sitting. Conservative treatments such as nonsteroidal anti-inflammatory drugs (NSAIDs), levator sudden relaxation exercises, seat cushions, and transcutaneous electrical simulation have all been used to relieve pain, but these methods are ineffective in 10% of patients. In the patient group unresponsive to conservative treatments, there are various interventional treatment options, including caudal epidural steroid injection, ganglion impar blocks, radiofrequency ablation of the sacral nerves, block of the coccygeal nerves and radiofrequency ablation, and coccygectomy.

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

In algoloji clinic, routinely apply ultrasound-guided coccygeal nerve block and radiofrequency ablation to patients with coccydynia. During the procedure, after imaging the sacral and coccygeal corns with ultrasonography, a radiofrequency ablation needle is inserted at the level of the coccygeal horn and radiofrequency ablation is applied at 90 degrees for 60 seconds. Patients are followed for a while in our post-procedure service for possible hypotension and allergic reactions. In this study, it was planned to apply the Visual Pain Scale (VAS) and Paris Functional Coccydynia Questionnaire at the 1st week, 1st month and 3rd months after the treatment to patients who had coccygeal nerve block and radiofrequency ablation in our clinic due to the complaint of coccydynia resistant to conservative treatment methods. In this way, it is planned to evaluate the efficacy of treatment.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Coccyx Disorder

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

Cocygeal nerve radiofrequency ablation group

During the procedure, after imaging the sacral and coccygeal corns with ultrasonography, a radiofrequency ablation needle is inserted at the level of the coccygeal horn and radiofrequency ablation is applied at 90 degrees for 60 seconds.

Group Type ACTIVE_COMPARATOR

Coccygeal nerve radiofrequency ablation

Intervention Type PROCEDURE

During the procedure, after imaging the sacral and coccygeal corns with ultrasonography, a radiofrequency ablation needle is inserted at the level of the coccygeal horn and radiofrequency ablation is applied at 90 degrees for 60 seconds.

Conservative treatment group

This group includes patients receiving conservative treatment such as nonsteroidal anti-inflammatory group drugs, physical therapy, and exercise for coccygeal pain.

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

Coccygeal nerve radiofrequency ablation

During the procedure, after imaging the sacral and coccygeal corns with ultrasonography, a radiofrequency ablation needle is inserted at the level of the coccygeal horn and radiofrequency ablation is applied at 90 degrees for 60 seconds.

Intervention Type PROCEDURE

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

Inclusion Criteria

* Coccygeal pain

Exclusion Criteria

* Malignancy
* İnfection
* Coagulation disorders
Minimum Eligible Age

18 Years

Maximum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

Diskapi Teaching and Research Hospital

OTHER

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Damla Yürük

Principal Investigator

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

Learn about the lead researchers overseeing the trial and their institutional affiliations.

Ömer Taylan Akkaya

Role: STUDY_DIRECTOR

Diskapi Yildirim Beyazıt Teaching and Research Hospital

Gevher Rabia Genç Perdecioğlu

Role: STUDY_CHAIR

Diskapi Yildirim Beyazıt Teaching and Research Hospital

Hüseyin Alp Alptekin

Role: STUDY_CHAIR

Diskapi Yildirim Beyazıt Teaching and Research Hospital

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

Diskapi Yildirim Beyazıt Teaching and Research Hospital

Ankara, , Turkey (Türkiye)

Site Status

Countries

Review the countries where the study has at least one active or historical site.

Turkey (Türkiye)

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

Coccygeal Nerve

Identifier Type: -

Identifier Source: org_study_id

More Related Trials

Additional clinical trials that may be relevant based on similarity analysis.