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NCT Number: NCT07757321

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

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.

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Key information

Conditions

Herniated Nucleus Pulposus PRF

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

RSUD Tarakan

Jakarta, DKI Jakarta, 10150, Indonesia

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

10% Dextrose Injection

Drug

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

Triamcinolone Injection

Drug

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

Primary outcomes

  1. Pain intensity measured by the Numeric Rating Scale (NRS)

    Time frame: 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 outcomes

  1. Functional disability measured by the Oswestry Disability Index (ODI)

    Time frame: Baseline and 14 days after intervention

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

  2. Neuropathic pain measured by the Neuropathic Pain Scale (NPS)

    Time frame: 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.

  3. Patient satisfaction

    Time frame: 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.

  4. Adverse events

    Time frame: From intervention through 14 days after intervention

Sponsors and collaborators

Lead sponsor

Indonesia University

Other

Registry information

Official study title

Comparison Between 10% Dextrose Injection and Triamcinolone as an Adjuvant to Pulsed Radiofrequency of the Dorsal Root Ganglion in Patients With Herniated Nucleus Pulposus

Important dates

Study start
2025
Primary completion
2026
Study completion
2026
First posted
Aug 11, 2026
Registry last updated
Aug 11, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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