Ignite Creation Date:
2024-10-25 @ 8:01 PM
Last Modification Date:
2024-10-26 @ 3:43 PM
Study NCT ID:
NCT06653179
Status:
NOT_YET_RECRUITING
Last Update Posted:
None
First Post:
2024-10-20
Brief Title:
Efficacy of Interventional Methods Used in the Treatment of Coccydynia
Sponsor:
None
Organization:
None
Study Overview
Official Title:
Comparison of the Efficacy of Sacral Erector Spinae Plane Block and Caudal Epidural Injection on Chronic Coccydynia A Randomized Controlled Trial
Status:
NOT_YET_RECRUITING
Status Verified Date:
2024-10
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
No
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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 05 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
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 05 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
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None