Bone Neoplasm,Malignant Vertebral Column Thoracic Secondary Clinical Trial
Official title:
Comparison Between Dorsal Root Ganglion Thermal Radiofrequency Versus Pulsed Radiofrequency for the Management of Intractable Metastatic Pain in Thoracic Vertebral Body
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.
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.
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