Combined Fluoroscopy and CT Guided Radiofrequency Ablation of Thoracic Dorsal Root Ganglia in Severe Thoracic Pain

A Modified Technique of Combined Fluoroscopy and CT Guided Thermal Radiofrequency Ablation of Thoracic Dorsal Root Ganglia in Intractable Pain Associated With Thoracic Malignancies: A Randomized Clinical Trial

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.

Study Overview

• Status: Completed
• Conditions: Cancer-related Problem/Condition
• Intervention / Treatment: Procedure: combined CT-fluroscopy; Procedure: standard fluroscopy

Detailed Description

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.

• Study Type: Interventional
• Enrollment (Actual): 78
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Egypt
  • Cairo, Egypt, 11796
    • Department of Anesthesia and Pain medicine.National Cancer Institute

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• patients aged 18 years or more
• suffering from chronic moderate-to-severe pain ( VAS score ≥ 40 mm)
• due to malignancy involving the chest and pain was refractory to the maximally tolerated dose of opioids for at least four weeks. Malignancies included : lung cancer, pleural mesothelioma, chest wall tumors and metastatic deposits of the chest.

Exclusion Criteria:

• sepsis, coagulopathy
• malignant epidural invasion
• distorted local anatomy
• severe cardiorespiratory compromise
• neuropsychiatric illness
• history of drug dependence and known allergy to contrast media or the used medications.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Interventional:Combined CT-fluroscopy; Combined CT-fluroscopic radiofrequency ablation of thoracic dorsal root ganglia.	Procedure: combined CT-fluroscopy; Radiofrequency ablation of thoracic dorsal root ganglia guided by combined CT-Fluroscopy
Active Comparator: Interventional: standard fluroscopy; Fluroscopic radiofrequency ablation of thoracic dorsal root ganglia.	Procedure: standard fluroscopy; Radiofrequency ablation of thoracic dorsal root ganglia guided by standard fluroscopy only

What is the study measuring?

Primary Outcome Measures

Outcome Measure	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

Secondary Outcome Measures

Outcome Measure	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.	12 weeks

Collaborators and Investigators

• Sponsor: National Cancer Institute, Egypt
• Investigators: Principal Investigator: Ehab H Shaker, MD, National Cancer Institute- Cairo University

Publications and helpful links

General Publications

• 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.

Helpful Links

• clinical journal of pain

Study record dates

Study Major Dates

• Study Start (Actual): April 1, 2017
• Primary Completion (Actual): October 31, 2017
• Study Completion (Actual): November 30, 2017

Study Registration Dates

• First Submitted: April 22, 2018
• First Submitted That Met QC Criteria: May 22, 2018
• First Posted (Actual): May 23, 2018

Study Record Updates

• Last Update Posted (Actual): May 30, 2018
• Last Update Submitted That Met QC Criteria: May 25, 2018
• Last Verified: May 1, 2018

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Neoplasms; Cysts; Connective Tissue Diseases; Mucinoses; Ganglion Cysts
• Other Study ID Numbers: Raafat-Ehab.combined

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO
• IPD Plan Description: It will be a shared team work study during which all the investigators will have equally distributed roles.

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No