Efficacy of Interventional Methods Used in the Treatment of Coccydynia
Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18-70
SponsorAnkara Etlik City Hospital
About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Chronic coccydynia unresponsive to conservative treatment
Male and female population aged 18-70
No previous interventional procedure performed during the treatment process
Disqualifiers
Coagulation disorders
Infections in the areas to be treated
Allergy to local anesthesia
Socio-cultural inadequacy
Trial design
Design model
Parallel
Treatments tested in this trial
Sacral Erector Spinae Plane Block
Procedure/SurgeryThe patient is placed in the prone positionon a procedure table. The sacral region is exposed, and the area is prepped with antiseptic solution under sterile conditions. The ultrasound high-frequency linear transducer is placed transversely over the sacrum. The sacral cornua are typically seen as bony structures adjacent to the sacral hiatus, appearing as two hyperechoic structures. Rotate the ultrasound probe to a sagittal position over the sacrum to align with the fourth and fifth sacral vertebrae. Under continuous ultrasound guidance, block needle is inserted in-plane with the ultrasound probe. Direct the needle through the soft tissue towards the plane between the erector spinae muscle and the sacrum. After confirming needle placement, the injectate mixture of 8 mg dexamethasone and 10 mg bupivacaine (0.5% concentration) is administered. A total volume of 10 mL is injected, and real-time ultrasound is used to observe the spread of the injectate within the target tissue plane.
Caudal Epidural Injection
Procedure/SurgeryThe patient is positioned in the prone position on the procedure table, and the sacral region is exposed and prepped with antiseptic solution under sterile conditions. The fluoroscope is positioned laterally to visualize the sacral hiatus. Under fluoroscopic guidance, the block needle is inserted through the skin and advanced toward the sacral hiatus. Continuous fluoroscopy is used to ensure correct needle placement, typically visualized at the level of the sacral canal. After confirming the appropriate position with contrast media, the injectate consisting of 8 mg dexamethasone and 10 mg bupivacaine (0.5% concentration) is slowly administered, with a total volume of 10 mL. During injection, careful monitoring of the needle position is performed to avoid intravascular injection. After the procedure, patients are monitored for potential complications such as hypotension and allergic reactions.
Treatment groups
94 Participants
are divided into 2 treatment groupsGroup A: Sacral Erector Spinae Plane Block GroupActive comparator 1 intervention
Group B: Caudal Epidural Injection GropuActive comparator 1 intervention
Trial outcomes
Primary outcomes
1
Numeric Rating Scale
Numeric Rating Scale is a scale that can be used measuring pain. Scores range from 0 (no pain) to 10 (the worst pain)
Time frame
Change from baseline to 1st and 2nd and twelfth week after treatment2
Paris Functional Coccydynia Scale
The Paris Functional Coccydynia Scale is designed to assess the functional impact of coccydynia on patients' daily lives. It comprises various items that evaluate pain intensity, functional limitations, and the effect of pain on daily activities. Scores range from 0 to 10, with higher scores indicating greater impairment and more severe symptoms.
Time frame
Change from baseline to 1st and 2nd and twelfth week after treatmentSponsors and contacts
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Source ClinicalTrials.gov
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