10% Dextrose Versus Triamcinolone Injections After Pulsed Radiofrequency for Herniated Nucleus Pulposus

Universitas Indonesia40 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

SINGLE

Enrollment

Conditions

Herniated Nucleus Pulposus PRF

Interventions

Eligibility

Sex: ALLMin age: 18 YearsMax age: 65 Years

Medical Language ↔ Plain English

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.

Outcomes

Primary Outcomes

Pain intensity measured by the Numeric Rating Scale (NRS)

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.

Time frame: Baseline, 2 hours, 24 hours, 48 hours, 7 days, and 14 days after intervention

Secondary Outcomes

Functional disability measured by the Oswestry Disability Index (ODI)

Oswestry Disability Index (ODI) total scores range from 0 to 100, with higher scores indicating greater disability.

Time frame: Baseline and 14 days after intervention

Neuropathic pain measured by the Neuropathic Pain Scale (NPS)

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.

Time frame: Baseline and 14 days after intervention

Patient satisfaction

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.

Time frame: 14 days after intervention

Adverse events

Time frame: From intervention through 14 days after intervention