Clinical trial · Interventional

Dorsal Root Ganglion Thermal Radiofrequency Versus Pulsed Radiofrequency for Metastatic Pain in Thoracic Vertebral Body

Comparison Between Dorsal Root Ganglion Thermal Radiofrequency Versus Pulsed Radiofrequency for the Management of Intractable Metastatic Pain in Thoracic Vertebral Body

NCT03204942CI-TRIAL-00045809completedN/AResults postedClinicalTrials.gov clinicaltrialsPublishedExplore in graph →

Summary

Brief summary (as posted)

AIM OF THE WORK To evaluate the effectiveness and safety of Pulsed and Thermal Radiofrequency lesion of the dorsal root ganglion (RF-DRG) on a consecutive group of patients presenting with chronic thoracic pain due to vertebral bone metastasis.

Conditions

Conditions (1)

Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.

Condition (as posted)	Mapped entity	Match	Confidence
Bone Neoplasm,Malignant Vertebral Column Thoracic Secondary	Bone Neoplasm	ONTOLOGY_EXACT	0.85

Interventions

Interventions (3)

Intervention	Type	Mapped drug	Match
Corticosteroid injection	Drug	—	UNRESOLVED
PRF on DRG	Device	—	UNRESOLVED
TRF on DRG	Device	—	UNRESOLVED

Design

Arms and outcomes

Arms (3)

type
ACTIVE_COMPARATOR
label
PRF on DRG
description
Patients will receive Pulsed Radiofrequency (PRF) on Dorsal root ganglion(DRG) of the selected metastatic painful dorsal vertebrae, with temperature 42°C for 480 sec.,2 active cycles per second of 20 milliseconds each , with a voltage output 40 to 60-V range, impedance ranges between 150 and 400 Ohms at all levels using Fluroscopic guidance (FG).
interventionNames
1. Device: PRF on DRG
type
ACTIVE_COMPARATOR
label
TRF on DRG
description
Patients will receive Thermal Radiofrequency (TRF) on Dorsal root ganglion(DRG) of the selected metastatic painful dorsal vertebrae, with temperature 80°C for 90 sec.,2 cycles, using Fluoroscopic guidance (FG) .
interventionNames
1. Device: TRF on DRG
type
ACTIVE_COMPARATOR

Eligibility

Eligibility (as posted)

Sex: All
Minimum age: 18 Years

Show eligibility criteria text

Inclusion Criteria:

1. A greater than 6-month history of segmental pain of thoracic vertebral body metastasis origin.
2. Unsatisfactory pain control with oral pharmacotherapy including strong opioid with VAS \>5 .
3. Absence of a chronic or progressive motor deficit.
4. Absence of significant sensory deficit.
5. No indication for percutaneous or open surgical intervention.
6. Magnetic resonance imaging and Computed Tomogrophy evidence of thoracic involvement.
7. ASA status of II to III .
8. Age \> 18 .
9. Body mass index (BMI) :less than forty and more than twenty .
10. Informed consent

Exclusion Criteria:

1. Known sensitivity or contraindication to injected materials: local anesthetics.
2. History of psychological disorders.
3. Evidence of significant neurological deficit.
4. Inability to lie prone.
5. Local contraindication to procedure e.g. local sepsis at the site of intervention, coagulopathy.
6. Patient refusal.

References

Publications (0)

Data not yet available

No reference posted for this study.

Registry

Dates and enrollment

Start: Feb 14, 2017
Primary completion: Jul 30, 2018
Completion: Jul 30, 2018
First posted: Jul 2, 2017
Last update posted: Jul 7, 2020
Results first posted: Jul 7, 2020
Enrollment: 69 (actual)
Lead sponsor: National Cancer Institute, Egypt OTHER
Keywords: Bone metastasis,Thoracic secondary, Cancer Pain,

Data updated 22 days agoSource updated Jul 7, 2020source: clinicaltrials

Locations

Locations by country (1)

Country	Sites	Recruiting
Egypt	1	0

Trial listing is informational. Eligibility is decided by the study team; contact information is on ClinicalTrials.gov.