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

May 25, 2018 updated by: Ehab Hanafy Shaker, National Cancer Institute, Egypt

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

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
78

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

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

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

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

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

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

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
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

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
pain relief.
Time Frame: 12 weeks follow up
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

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
patient satisfaction.
Time Frame: 12 weeks
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

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
National Cancer Institute, Egypt

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Ehab H Shaker, MD, National Cancer Institute- Cairo University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
April 1, 2017

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
October 31, 2017

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
November 30, 2017

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
April 22, 2018

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
May 22, 2018

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
May 23, 2018

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
May 30, 2018

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
May 25, 2018

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
May 1, 2018

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant 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

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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