Clinical trial NCT03204942: Dorsal Root Ganglion Thermal Radiofrequency Versus Pulsed Radiofrequency for Metastatic Pain in Thoracic Vertebral Body
Official title: Comparison Between Dorsal Root Ganglion Thermal Radiofrequency Versus Pulsed Radiofrequency for the Management of Intractable Metastatic Pain in Thoracic Vertebral Body
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Bone Neoplasm,Malignant Vertebral Column Thoracic Secondary
Keywords: Bone metastasis,Thoracic secondary, Cancer Pain,
Lead sponsor: National Cancer Institute, Egypt
Sponsor class: OTHER
First posted: 2017-07-02
Enrollment: 69
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

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.

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.

Primary outcomes:
measure: The European Organisation for Research and Treatment of Cancer (EORTC) Questionnaire to Measure Change in the Intensity of Pain QLQ-C30
timeFrame: Assessment done at 3 months after the procedure.
measure: EORTC QLQ-BM22
timeFrame: Assessment done at 3 months after the procedure.
measure: Visual Analog Scale (VAS), to Evaluate Pain
timeFrame: Assessment of pain done at 3 months after the procedure.
measure: Oswestry Low Back Pain Disability Questionnaire (ODI),
timeFrame: Assessment of pain done at 3 months after the procedure.
Secondary outcomes:
measure: Number of Participants With Any Complications
timeFrame: Assessment done at 3 months after the procedure
measure: To Measure Change in Analgesic Usage
timeFrame: Assessment was done before intervention and at at 3 months after the procedure.
measure: Patients' Satisfaction, Descriptive Scale
timeFrame: a week after procedure
Other outcomes:
Locations:
city: Cairo
country: Egypt
facility: Sherry Nabil Elia Fanous
Study officials:
affiliation: National Cancer Institute, Egypt
name: Sherry Na Fanous, M.Sc.
role: PRINCIPAL_INVESTIGATOR
References: