Clinical trial NCT06653179: Efficacy of Interventional Methods Used in the Treatment of Coccydynia
Official title: Comparison of the Efficacy of Sacral Erector Spinae Plane Block and Caudal Epidural Injection on Chronic Coccydynia: A Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: Coccydynia
Erector Spinae Plane Block
Caudal Block
Keywords: Sacral Erector Spinae Plane Block
Caudal. Epidural Injection
Chronic Coccydynia
Lead sponsor: Ankara Etlik City Hospital
Sponsor class: OTHER_GOV
First posted: 2024-10-22
Enrollment: 94
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: This study aims to evaluate the effectiveness of sacral erector spinae plane block and caudal epidural injection in patients with coccydynia resistant to conservative treatments. Ultrasound guidance will be used for sacral erector spinae plane block, while fluoroscopic guidance will be applied for caudal epidural injection. The effectiveness of these treatments will be assessed through face-to-face questionnaires, the Numerical Rating Scale and the Paris Functional Coccydynia Scale at first, fourth and twelfth-week follow-ups.

Detailed description: Coccydynia (coccygodynia, coccalgia) or coccygeal pain is a painful syndrome affecting the coccyx region. The most important etiological factors in the formation of coccydynia are external and internal trauma, though it can also occur idiopathically. The pain intensifies while sitting or standing up from a sitting position. Although it can affect individuals of all ages and genders, the average onset age is 40, with a prevalence 5 times higher in women. Coccydynia is a painful condition that impacts quality of life, and its treatment can be challenging due to the influence of various physiological and psychological factors.

Patients typically complain of pain in the tailbone area, which increases with prolonged sitting, leaning backward while sitting, standing for extended periods, and rising from a sitting position. Conservative treatments such as nonsteroidal anti-inflammatory drugs, levator ani relaxation exercises, seating cushions, and transcutaneous electrical stimulation are commonly used, but these methods are ineffective in 10% of cases.

For patients unresponsive to conservative treatments, interventional and surgical options include caudal epidural steroid injection, sacral erector spinae plane block, ganglion impar blocks, radiofrequency ablation of sacral nerves, block and radiofrequency ablation of coccygeal nerves, and coccygectomy.

Sacral erector spinae plane block under ultrasound guidance or caudal epidural injection under fluoroscopic guidance is performed under sterile conditions for patients with resistant and chronic coccydynia. For the sacral erector spinae plane block, the sacral and coccygeal cornua are visualized in a transverse position under ultrasound, followed by sagittal positioning of the probe over the sacrum for injection at the 4th and 5th sacral vertebrae. For caudal epidural injection, the fluoroscope is positioned laterally, and the injection is administered to the target area under fluoroscopic imaging. In both techniques, the injectate consists of 8 mg dexamethasone and 10 mg bupivacaine (0.5% concentration), with a total volume of 10 mL. After the procedure, patients are monitored for potential hypotension and allergic reactions as a precaution.

This study will include patients treated with sacral erector spinae plane block and caudal epidural injection for coccydynia resistant to conservative treatments. Face-to-face questionnaires, Numerical Rating Scale scores, and the Paris Functional Coccydynia Scale will be evaluated at 1, 4, and 12-week follow-ups.

Eligibility criteria: Inclusion Criteria:

* Chronic coccydynia unresponsive to conservative treatment
* Male and female population aged 18-70
* No previous interventional procedure performed during the treatment process

Exclusion Criteria:

* Coagulation disorders
* Infections in the areas to be treated
* Allergy to local anesthesia
* Socio-cultural inadequacy
* Mental retardation
* Pregnancy
* Previous interventional procedure performed
* Patient refusal of the interventional procedure
* Presence of malignancy in the coccygeal region
* Previous surgery in the coccygeal region

Primary outcomes:
measure: Numeric Rating Scale
timeFrame: Change from baseline to 1st and 2nd and twelfth week after treatment
measure: Paris Functional Coccydynia Scale
timeFrame: Change from baseline to 1st and 2nd and twelfth week after treatment
Secondary outcomes:
Other outcomes:
Locations:
city: Ankara
country: Turkey
facility: Ankara Etlik City Hospital
state: Etlik
Study officials:
References: