Health Condition 1: null- Low back pain with radicular pain. Health Condition 2: G541- Lumbosacral plexus disorders
Conditions
Interventions
Intervention1: Group PRF: Patient in this group will receive Pulsed Radio Frequency (PRF) of Dorsal Route Ganglion (DRG)
Control Intervention1: group Sham: Patient in this group will have only Pulsed
Sponsors
Post Graduate Institute of Medical Education and Research
Eligibility
Inclusion criteria
Inclusion criteria: Male and female patients over the age of 18 years who have a unilateral lumbar radicular pain due to disc herniation on magnetic resonance imaging, correlating clinically in terms of level and side and are due for elective PRF to treat their pain.
Exclusion criteria
Exclusion criteria: 1. Other pain conditions that may confound the assessment of their radicular pain, as judged by the investigator(s) 2. Patients who have had previous back surgery to treat their radicular pain (‘failed back surgery syndrome’) 3. Patients with a known condition that may preclude their participation in the study, as judged by the investigator(s) 4. Patients taking anticoagulant or antiplatelet medication (except for low-dose aspirin), or known to have coagulation disorders, as judged by the investigator(s) 5. Patients with localized or systemic sepsis a. Localized sepsis: infection of the skin at site of entry of the PRF probe 6. Breast-feeding women 7. Positive pregnancy test 8. Participation in other clinical trials, use of investigational drugs or procedures or use of experimental medications within 30 days prior to the enrolment visit 9. Previous randomisation in the present study 10. Females must not be breastfeeding.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Proportion of patients achieving effective pain relief (EPR) in each group will be considered as primary endpoint. We will define the approach as “effective ? when pain relief will be = 50% reduction from baseline on Verbal Numerical Rating Scale.Timepoint: 3 months after the procedure | — |
Secondary
| Measure | Time frame |
|---|---|
| To assess the Quantitative sensory testing (QST) measurements, changes in functional disability, changes in quality of life measured by health-related quality of life tools, and improved clinical and cost effectiveness using quality-adjusted life years measurement.Timepoint: 1. At baseline. 2. On week after procedure 3. at 3 months post-procedure. | — |
Countries
India
Contacts
Public ContactBabita Ghai
Post Graduate Institute of Medical Education and Research
Outcome results
None listed