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

NCT ID: NCT03204942

Last Updated: 2020-07-07

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 69 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2017-02-14
• Study Completion Date: 2018-07-30

Brief Summary

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.

Detailed 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.

Conditions

Bone Neoplasm,Malignant Vertebral Column Thoracic Secondary

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: SUPPORTIVE_CARE
• Blinding Strategy: TRIPLE

Study Groups

PRF on DRG

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).

Group Type: ACTIVE_COMPARATOR

PRF on DRG

Intervention Type: DEVICE

RF will be performed with the patient in a prone position with mild flexion of the spine. Fluoroscopy beam positioned in an antero-posterior direction. A 10 cm RF needle 20 G with a 10 mm active tip.The needle is inserted in a slightly medial-cephalad direction under the transverse processes, and using lateral fluoroscopic imaging, incrementally walking into the thoracic intervertebral foramen. So the location of the needle tip confirmed by sensory stimulation at 50 Hz. The point of maximum stimulation is at 0.5 V intensity and this is designated to be the location of the DRG. Slight redirection can be done to optimize the stimulation; injection of contrast reveals epidural uptake. After establishing the site for the RF, 1 ml 2% lidocaine should be injected through the needle.

TRF on DRG

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) .

Group Type: ACTIVE_COMPARATOR

TRF on DRG

Intervention Type: DEVICE

Similar to the group of " PRF on DRG", but the types of the waves will be different as previously described

Control group

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).

Group Type: ACTIVE_COMPARATOR

Corticosteroid injection

Intervention Type: DRUG

Similar to the previous groups, but without applying any type of Radio-frequency but just injecting steroids and local anesthetics as previously described

Interventions

PRF on DRG

RF will be performed with the patient in a prone position with mild flexion of the spine. Fluoroscopy beam positioned in an antero-posterior direction. A 10 cm RF needle 20 G with a 10 mm active tip.The needle is inserted in a slightly medial-cephalad direction under the transverse processes, and using lateral fluoroscopic imaging, incrementally walking into the thoracic intervertebral foramen. So the location of the needle tip confirmed by sensory stimulation at 50 Hz. The point of maximum stimulation is at 0.5 V intensity and this is designated to be the location of the DRG. Slight redirection can be done to optimize the stimulation; injection of contrast reveals epidural uptake. After establishing the site for the RF, 1 ml 2% lidocaine should be injected through the needle.

Intervention Type: DEVICE

TRF on DRG

Similar to the group of " PRF on DRG", but the types of the waves will be different as previously described

Intervention Type: DEVICE

Corticosteroid injection

Similar to the previous groups, but without applying any type of Radio-frequency but just injecting steroids and local anesthetics as previously described

Intervention Type: DRUG

Eligibility Criteria

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.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

National Cancer Institute, Egypt

OTHER

Sponsor Role: lead

Responsible Party

Sherry N. Fanous

Principal Investigator

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Sherry Na Fanous, M.Sc.

Role: PRINCIPAL_INVESTIGATOR

National Cancer Institute, Egypt

Locations

Sherry Nabil Elia Fanous

Cairo, , Egypt

Countries

Egypt

Provided Documents

Document Type: Study Protocol and Statistical Analysis Plan

View Document

Other Identifiers

CdGrPfMiPnB

Identifier Type: -

Identifier Source: org_study_id