N/A
N=69
Dorsal Root Ganglion Thermal Radiofrequency Versus Pulsed Radiofrequency for Metastatic Pain in Thoracic Vertebral Body
Bone Neoplasm,Malignant Vertebral Column Thoracic Secondary
Bottom Line
View on ClinicalTrials.gov: NCT03204942 ↗Enrolled (actual)
69
Serious AEs
0.0%
Results posted
Jul 2020
Primary outcome: Primary: The European Organisation for Research and Treatment of Cancer (EORTC) Questionnaire to Measure Change in the Intensity of Pain QLQ-C30 — 41.30; 51.08; 38.76; 42.48 score on a scale
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- PRF on DRG (Device); TRF on DRG (Device); Corticosteroid injection (Drug)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- National Cancer Institute, Egypt
- Primary completion
- Jul 2018
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY The European Organisation for Research and Treatment of Cancer (EORTC) Questionnaire to Measure Change in the Intensity of Pain QLQ-C30 |
41.30; 51.08; 38.76; 42.48; 46.53; 54.96 | — |
| PRIMARY EORTC QLQ-BM22 |
50.43; 35.07; 44.36; 41.54; 30.41; 34.75 | — |
| PRIMARY Visual Analog Scale (VAS), to Evaluate Pain |
68.57; 48.78; 66.17 | — |
| PRIMARY Oswestry Low Back Pain Disability Questionnaire (ODI), |
62.52; 52.87; 61.61 | — |
| SECONDARY Number of Participants With Any Complications |
0; 7; 1 | — |
| SECONDARY To Measure Change in Analgesic Usage |
4.30; 4.57; 3.87; 3.43; 2.70; 3.52 | — |
| SECONDARY Patients' Satisfaction, Descriptive Scale |
1; 16; 0; 5; 2; 6 | — |
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.
Eligibility Criteria
Inclusion Criteria
- A greater than 6-month history of segmental pain of thoracic vertebral body metastasis origin.
- Unsatisfactory pain control with oral pharmacotherapy including strong opioid with VAS >5 .
- Absence of a chronic or progressive motor deficit.
- Absence of significant sensory deficit.
- No indication for percutaneous or open surgical intervention.
- Magnetic resonance imaging and Computed Tomogrophy evidence of thoracic involvement.
- ASA status of II to III .
- Age > 18 .
- Body mass index (BMI) : less than forty and more than twenty .
- Informed consent
Exclusion Criteria
- Known sensitivity or contraindication to injected materials: local anesthetics.
- History of psychological disorders.
- Evidence of significant neurological deficit.
- Inability to lie prone.
- Local contraindication to procedure e.g. local sepsis at the site of intervention, coagulopathy.
- Patient refusal.
Data sourced from ClinicalTrials.gov (NCT03204942). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.