Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
In the current study, extra-guidance other than conventional fluoroscopy - will be integrated to improve the success of the transforaminal approach to the thoracic dorsal root ganglia (DRG). The investigators hypothesize that joining CT scan with fluoroscopy to guide RF ablation through the transforaminal route may enhance its efficacy and safety in relieving the intractable pain associated with chest malignancies. The current study aimed to compare the results of thermal radiofrequency ablation (TRFA) of the thoracic DRG under combined CT and fluoroscopy guidance with the classic standard fluoroscopy technique.
Thoracic pain represents about 3-5% of pain clinics' visitors worldwide .Post-thoracotomy pain occurs in 30%-50% of patients undergoing thoracotomy .Interventional therapies include epidural or intrathecal drug injection, intercostal nerve block, sympathectomy, rhizotomy, and percutaneous cervical cordotomy. Rhizotomy refers to the selective segmental destruction of the dorsal sensory rootlets to interrupt pain perception by the spinal cord. This could be accomplished either neurosurgically, chemically or using selective percutaneous procedures such as cryoanalgesia and radiofrequency (RF) ablation.There are many technical difficulties in approaching the deep-seated thoracic dorsal root ganglia (DRG) through the transforaminal route.The spine is kyphotic - with the tip at T6 - and slightly scoliotic to the right side even in normal subjects . Spinous processes are acute, especially at T5-T8 level. Besides, broad and wide laminae together with narrow intervertebral foramina are other obstacles .The intervertebral foramina are further masked by the facet joints and the crowdedness of the costovertebral and the costotransverse joints .For all these factors, more guidance - other than conventional fluoroscopy - may improve the success of the transforaminal approach to the thoracic DRG. The investigators hypothesize that joining CT scan with fluoroscopy to guide RF ablation through the transforaminal route can enhance its efficacy and safety in relieving the intractable pain of chest malignancies. The current study aimed to compare the results of thermal radiofrequency ablation (TRFA) of the thoracic DRG under combined CT and fluoroscopy guidance with the classic standard fluoroscopy technique.
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Interventional:Combined CT-fluroscopy | Active Comparator | Combined CT-fluroscopic radiofrequency ablation of thoracic dorsal root ganglia. |
|
| Interventional: standard fluroscopy | Active Comparator | Fluroscopic radiofrequency ablation of thoracic dorsal root ganglia. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| combined CT-fluroscopy | Procedure | Radiofrequency ablation of thoracic dorsal root ganglia guided by combined CT-Fluroscopy |
|
| Measure | Description | Time Frame |
|---|---|---|
| pain relief. | Pain intensity measured by visual analog scale (VAS).It measures the pain intensity and percentage of pain relief.The investigators used 100 mm horizontal scale with left zero end representing no pain and right 100 end representing worst pain.Scores ranging 0-39 reflect mild pain , 40-69 moderate pain and 70-100 severe pain. | 12 weeks follow up |
| Measure | Description | Time Frame |
|---|---|---|
| patient satisfaction. | The secondary outcome measure will be assessed using patient satisfaction with the patient global impression of changes (PGIC).It measures the degree of patient overall satisfaction after the performed procedure. It includes 7 domains ranging from 1 to 7. the first domain indicates that the patient is very much improved while the 7th domain indicates that he is very much worsened by the procedure. |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Affiliation | Role |
|---|---|---|
| Ehab H Shaker, MD | National Cancer Institute- Cairo University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Department of Anesthesia and Pain medicine.National Cancer Institute | Cairo | 11796 | Egypt |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 31852438 | Derived | Reyad RM, Ghobrial HZ, Shaker EH, Reyad EM, Shaaban MH, Hashem RH, Darwish WM. Modified technique for thermal radiofrequency ablation of Thoracic dorsal root ganglia under combined fluoroscopy and CT guidance: a randomized clinical trial. BMC Anesthesiol. 2019 Dec 18;19(1):234. doi: 10.1186/s12871-019-0906-4. |
| Label | URL |
|---|---|
| clinical journal of pain | View source |
Not provided
It will be a shared team work study during which all the investigators will have equally distributed roles.
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| standard fluroscopy | Procedure | Radiofrequency ablation of thoracic dorsal root ganglia guided by standard fluroscopy only |
|
| 12 weeks |