Herniated Nucleus Pulposus, PRF
Conditions
Keywords
Pulsed Radiofrequency, Dorsal Root Ganglion, Transforaminal Epidural Injection, Dextrose 10%, Triamcinolone, Chronic Low Back Pain, Adjuvant therapy
Brief summary
Lumbar herniated nucleus pulposus (HNP) is a common cause of chronic low back pain and radiculopathy. Transforaminal epidural steroid injection is commonly used as an adjuvant following pulsed radiofrequency (PRF) treatment but is associated with potential steroid-related adverse effects. Ten percent dextrose has been proposed as a regenerative, non-steroidal alternative. This single-blind randomized controlled trial compares the effectiveness of transforaminal epidural 10% dextrose versus triamcinolone administered after PRF in reducing pain, disability, and neuropathic pain in patients with lumbar HNP over a 14-day follow-up period.
Interventions
DRUG10% Dextrose Injection
Injection of 10% dextrose administered as an adjuvant following pulsed radiofrequency of the dorsal root ganglion.
Injection of triamcinolone administered as an adjuvant following pulsed radiofrequency of the dorsal root ganglion.
Sponsors
Indonesia University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Subject)
Masking description
Participants are blinded to treatment allocation. The investigator performing the intervention is aware of the assigned treatment because of differences in the study medications. Outcome assessments are conducted according to the study protocol.
Intervention model description
Participants are randomly assigned in a 1:1 ratio to receive either 10% dextrose injection or triamcinolone injection as adjuvant therapy following dorsal root ganglion pulsed radiofrequency. Outcomes are assessed over a 14-day follow-up period, and participants remain in their assigned intervention group throughout the study.
Eligibility
Sex/Gender
ALL
Age
18 Years to 65 Years
Healthy volunteers
No
Inclusion criteria
* Adults aged 18-65 years. * Diagnosed with lumbar herniated nucleus pulposus (HNP) confirmed by magnetic resonance imaging (MRI). * Chronic low back pain and/or radicular pain for at least 3 months. * Numeric Rating Scale (NRS) pain score ≥4. * No indication for surgical intervention. * Eligible for pulsed radiofrequency of the dorsal root ganglion with transforaminal epidural injection. * Able to understand the study procedures and provide written informed consent.
Exclusion criteria
* Previous lumbar spine surgery. * Progressive neurological deficits or cauda equina syndrome. * Indication for immediate spinal surgery. * Known hypersensitivity to dextrose, triamcinolone, local anesthetics, or study medications. * Coagulation disorders or current anticoagulant therapy that cannot be safely discontinued. * Local or systemic infection. * Pregnancy or breastfeeding. * Uncontrolled diabetes mellitus or other severe uncontrolled systemic disease. * Severe psychiatric illness or cognitive impairment affecting study participation. * Participation in another interventional clinical trial. * Inability or unwillingness to complete the scheduled follow-up assessments.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Pain intensity measured by the Numeric Rating Scale (NRS) | Baseline, 2 hours, 24 hours, 48 hours, 7 days, and 14 days after intervention | Pain intensity will be assessed using the Numeric Rating Scale (NRS) ranging from 0 to 10, where 0 indicates no pain and 10 indicates the worst pain. Higher scores indicate greater pain intensity. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Functional disability measured by the Oswestry Disability Index (ODI) | Baseline and 14 days after intervention | Oswestry Disability Index (ODI) total scores range from 0 to 100, with higher scores indicating greater disability. |
| Neuropathic pain measured by the Neuropathic Pain Scale (NPS) | Baseline and 14 days after intervention | Neuropathic pain will be assessed using the Neuropathic Pain Scale (NPS). The total score is calculated as the sum of the scores from the seven pain quality items, and the mean total score will be used for analysis. Higher scores indicate greater neuropathic pain severity. |
| Patient satisfaction | 14 days after intervention | Patient satisfaction with the treatment effect will be assessed using a 10-point satisfaction rating scale, where 1 indicates the lowest level of satisfaction and 10 indicates the highest level of satisfaction. Higher scores indicate greater patient satisfaction with the treatment effect. |
| Adverse events | From intervention through 14 days after intervention | — |
Countries
Indonesia
Outcome results
None listed