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

NCT07757321 | Completed

• 1 other identifier: 2206145664
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 1

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.

Conditions

Herniated Nucleus Pulposus; PRF

Keywords

Pulsed Radiofrequency; Dorsal Root Ganglion; Transforaminal Epidural Injection; Dextrose 10%; Triamcinolone; Chronic Low Back Pain; Adjuvant therapy

Outcome Measures

Primary Outcomes (1)

• 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.

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

Secondary Outcomes (4)

• Functional disability measured by the Oswestry Disability Index (ODI)

  Baseline and 14 days after intervention

• Neuropathic pain measured by the Neuropathic Pain Scale (NPS)

  Baseline and 14 days after intervention

• Patient satisfaction

  14 days after intervention

• Adverse events

  From intervention through 14 days after intervention

Study Arms (2)

10% Dextrose Group

EXPERIMENTAL

Drug: 10% Dextrose Injection

Triamcinolone Group

ACTIVE COMPARATOR

Drug: Triamcinolone Injection

Interventions

10% Dextrose Injection DRUG

Injection of 10% dextrose administered as an adjuvant following pulsed radiofrequency of the dorsal root ganglion.

10% Dextrose Group

Triamcinolone Injection DRUG

Injection of triamcinolone administered as an adjuvant following pulsed radiofrequency of the dorsal root ganglion.

Triamcinolone Group

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Indonesia University: lead

Study Sites (1)

RSUD Tarakan

Jakarta, DKI Jakarta, 10150, Indonesia

Location

MeSH Terms

Interventions

Glucose; Triamcinolone

Intervention Hierarchy (Ancestors)

Hexoses; Monosaccharides; Sugars; Carbohydrates; Pregnadienes; Pregnanes; Steroids; Fused-Ring Compounds; Polycyclic Compounds; Steroids, Fluorinated

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Masking Details: 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.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Model Details: 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.

Study Record Dates

• First Submitted: July 30, 2026
• First Posted: August 11, 2026
• Study Start: December 5, 2025
• Primary Completion: May 20, 2026
• Study Completion: June 3, 2026
• Last Updated: August 11, 2026

Record last verified: 2026-08

Data Sharing

• IPD Sharing: Will not share

Locations

ID (1)