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Effectiveness of Additional Bipolar Pulsed Radiofrequency Treatment for Chronic Lumbosacral Radicular pain: A Randomized Controlled Trial

Effectiveness of Additional Bipolar Pulsed Radiofrequency Treatment for Chronic Lumbosacral Radicular pain: A Randomized Controlled Trial

Status
Active, not recruiting
Phases
Phase 2Phase 3
Study type
Interventional
Source
TCTR
Registry ID
TCTR20250527008
Enrollment
76
Registered
2025-05-27
Start date
2025-07-01
Completion date
Unknown
Last updated
2026-08-03

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Patients receiving treatment for lumbosacral radicular pain at the Pain Clinic, Chulalongkorn Hospital Bipolar, radiofrequency, radicular pain, neuromodulation

Interventions

On the day of the procedure, the experimental group underwent sterile procedures with monitoring equipment. This group received two electrode of bipolar pulsed radiofrequency treatment at dorsal root
bipolar radiofrequency neuromodulation at dorsal root ganglia with transforaminal epidural steroid injection through nerve root,transforaminal epidural steroid injection through nerve root

Sponsors

Faculty of Medicine at Chulalongkorn University
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 75 Years

Inclusion criteria

Inclusion criteria: 1. ASA class I-III 2. aged 18-75 years 3. Patients with lumbosacral radicular pain more than 3 months and has not responded to conservative treatment 4. MRI of lumbar spine showed degenerative lower back pain, spinal canal stenosis, spinal disc prolapse, or herniated disc that compresses nerve, which cause of radicular pain and no other lesions that may be the main cause of radicular pain were found 5. The sites to be operated on were equal or less than 2 sites

Exclusion criteria

Exclusion criteria: 1. Patients who refused treatment with bipolar pulsed radiofrequency ablation combined with intraspinal steroid injection through the nerve root 2. Patients with S1 radicular symptoms 3. Patients with infection at the surgical site 4. Patients who had undergone previous spinal surgery on lumbar spine 5. Patients with progressive neurological deficit and Cauda equina syndrome 6. Patients with abnormal blood clotting 7. Patients with allergies to the study drugs 8. Patients who could not provide pain scores 9. Patients with pain in any location more severe than nerve radiating pain 10. Pregnant patients 11. Patients who were taking chronic opioid use in doses greater than 90 mg/day (Morphine milligram equivalent more than 90 mg/day)

Design outcomes

Primary

MeasureTime frame
success rate at 2 weeks, 3 month,6 months after intervention pain score of less than 4 out of 10 or greater than or equal to 50% reduction in pain scores

Secondary

MeasureTime frame
Pain scores at different time points pre intervention, 2 weeks, 1 month, 2 months, 3 month, 4 months,5 months, 6 month after intervention NRS,disability pre intervention, 2 weeks, 3 months, 6 months after intervention ODI,adverse events and side effects immediate post treatment, 2 weeks, 1 month, 2 months, 3 months, 4 months, 4 months, 5 months, 6 months after intervention adverse events and side effects

Countries

Thailand

Contacts

Public ContactChanon Thanaboriboon

Faculty of Medicine, Chulalongkorn University

chanon.thanaboriboon@gmail.com026494000

Outcome results

None listed

Source: TCTR (via WHO ICTRP) · Data processed: Aug 10, 2026