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

National Cancer Institute, Egypt

Status: Completed

Conditions: Bone Neoplasm,Malignant Vertebral Column Thoracic Secondary

Treatments: Device: PRF on DRG; Device: TRF on DRG; Drug: Corticosteroid injection

Study type: Interventional

Funder types: Other

Identifiers

NCT03204942

CdGrPfMiPnB

Details and patient eligibility

About

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.

Full description

STUDY DESIGN This is a Prospective Randomized Controlled trial that will be conducted at the National Cancer Institute. All patients who are eligible for the study will be included and randomized into 3 equal groups.

PATIENTS AND METHODS After approval from the Ethics Committee at the National Cancer Institute, Cairo University, and obtaining written informed consent, eighty-one patients with thoracic segmental pain due to metastasis, unresponsive to conventional therapy and meeting the inclusion criteria will be randomly assigned to either one of the two types of treatment, PRF or TRF lesioning of the DRG or the control group. Patients will be carefully evaluated for neurologic deficits and side effects. Assessment of pain will be done at baseline then at 1, 3, 6 months after the procedure. Randomization will be done using randomized permuted block design. Randomization list will be generated through random.org online site.

Patients will be randomly assigned and divided into 3 equal comparable groups. Before the procedure, laboratory investigations, Dorsal X-ray, CT and MRI will be done. All Patients will be interviewed and examined by physicians trained in interventional pain management. Patients will be carefully assessed on physical exam for sensory, motor, or reflex deficit and carefully documented. Patients will be informed about the technique of the blocks, and written informed consents will be obtained.

The types of measures used to assess pain relief will include single rating scales; VAS, and multiple-dimension composite measures; Oswestry Low Back Pain Disability Questionnaire (ODI), The European Organisation for Research and Treatment of Cancer (EORTC) QLQ-C30 and QLQ-BM22.

Enrollment: 69 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Supportive Care

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

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69 participants in 3 patient groups

PRF on DRG

Active Comparator group

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).

Treatment:

Device: PRF on DRG

TRF on DRG

Active Comparator group

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) .

Treatment:

Device: TRF on DRG

Control group

Active Comparator group

Description:

The control group will have identical needle placement and preparation like the 2 previous groups without the RF lesion, but with the injection of particulate Betamethasone steroids and local anesthetic on DRG of the selected metastatic painful dorsal vertebrae, using Fluoroscopic guidance (FG).

Treatment:

Drug: Corticosteroid injection