Herniated Nucleus PulposusNCT07757321
10% Dextrose Versus Triamcinolone Injections After Pulsed Radiofrequency for Herniated Nucleus Pulposus
A study testing 10% Dextrose Injection and Triamcinolone Injection in people with Herniated Nucleus Pulposus and PRF, run by Universitas Indonesia at 1 site in Indonesia.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Herniated Nucleus Pulposus, PRF
- What is being tested?
- 10% Dextrose Injection and Triamcinolone Injection
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 1 siteIndonesia
- Study dates
- 5 Dec 2025to 3 Jun 2026
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
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- 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.
Trial locations and contacts
1 site in 1 country.
About this study
Official 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
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
- Being tested
- 10% Dextrose Injection, Triamcinolone Injection
- Keywords
- Pulsed Radiofrequency, Dorsal Root Ganglion, Transforaminal Epidural Injection, Dextrose 10%, Triamcinolone, Chronic Low Back Pain, Adjuvant therapy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
10% Dextrose InjectionDrug
Injection of 10% dextrose administered as an adjuvant following pulsed radiofrequency of the dorsal root ganglion.
Triamcinolone InjectionDrug
Injection of triamcinolone administered as an adjuvant following pulsed radiofrequency of the dorsal root ganglion.
| Study group | Role | What they receive |
|---|---|---|
| 10% Dextrose Group | Experimental | Not described Receives: Drug: 10% Dextrose Injection |
| Triamcinolone Group | Active comparator | Not described Receives: Drug: Triamcinolone Injection |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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)
Oswestry Disability Index (ODI) total scores range from 0 to 100, with higher scores indicating greater disability.
Measured: 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.
Measured: 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.
Measured: 14 days after intervention
Adverse events
Measured: From intervention through 14 days after intervention
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Aug 2026
- Study start5 Dec 2025
- Primary completion20 May 2026
- Study completion3 Jun 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Herniated Nucleus PulposusStudies of the same condition, open and under way.
- More trials run by Universitas IndonesiaThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- 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.
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 40 participants (actual)
Sponsor and investigators
- Lead sponsor
- Universitas Indonesia
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Pryambodho Pryambodho, Universitas Indonesia
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07757321
- Sponsor's protocol ID
- 2206145664
- Status last verified
- Aug 2026
- First submitted
- 30 Jul 2026
- Last updated
- 11 Aug 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 11 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official 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
- ClinicalTrials.gov ID
- NCT07757321
- Acronym / sponsor ID
- 2206145664
- Conditions
- Herniated Nucleus Pulposus, PRF
- Keywords
- Pulsed Radiofrequency, Dorsal Root Ganglion, Transforaminal Epidural Injection, Dextrose 10%, Triamcinolone, Chronic Low Back Pain, Adjuvant therapy
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 40 participants (actual)
- Lead sponsor
- Universitas IndonesiaUniversity, hospital or other
- Study start
- 5 Dec 2025 (actual)
- Primary completion
- 20 May 2026 (actual)
- Study completion
- 3 Jun 2026 (actual)
- First posted
- 11 Aug 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
- 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.
| Arm | Type | Receives |
|---|---|---|
| 10% Dextrose Group | Experimental | Drug: 10% Dextrose Injection |
| Triamcinolone Group | Active comparator | Drug: Triamcinolone Injection |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- 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.
Key exclusion criteria (11 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| 10% Dextrose InjectionInjection of 10% dextrose administered as an adjuvant following pulsed radiofrequency of the dorsal root ganglion. | Drug | 10% Dextrose Group |
| Triamcinolone InjectionInjection of triamcinolone administered as an adjuvant following pulsed radiofrequency of the dorsal root ganglion. | Drug | Triamcinolone Group |
Primary outcome
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.
4 secondary outcomes
Functional disability measured by the Oswestry Disability Index (ODI)
Time frame: Baseline and 14 days after intervention
Neuropathic pain measured by the Neuropathic Pain Scale (NPS)
Time frame: Baseline and 14 days after intervention
Patient satisfaction
Time frame: 14 days after intervention
Adverse events
Time frame: From intervention through 14 days after intervention
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Aug 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing 10% Dextrose Injection and Triamcinolone Injection in people with Herniated Nucleus Pulposus and PRF, run by Universitas Indonesia at 1 site in Indonesia.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 11 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 11 Aug 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Indonesia. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 11 Aug 2026.