An investigation of the effect of high frequency wave treatment of the spinal nerves on chemicals released into the spinal fluid and bloodstream, and the effect on patient outcomes

An investigation of the effect of Pulsed Radiofrequency treatment of the Dorsal Root Ganglion on cerebrospinal fluid and peripheral venous blood cellular, proteomic and neuropeptide concentrations with clinical outcome correlation in patients with chronic lumbosacral radicular pain

Status

Active, not recruiting

Phases

Unknown

Study type

Interventional

Source

ISRCTN

Registry ID

ISRCTN60691016

Enrollment

Registered

2020-01-01

Start date

2020-01-22

Completion date

Unknown

Last updated

2021-01-05

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

Conditions

Chronic, radicular, lumbosacral pain Nervous System Diseases Radiculopathy

Interventions

Patients will be randomised to receive a single session of pulsed radiofrequency therapy (PRF) or a sham procedure. PRF is a treatment for chronic pain which occurs in the path of a p

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: 1. Age range 18-60 years 2. Unilateral monosegmental radicular pain in the lumbosacral nerve roots 3. Symptoms consistent with MRI findings of a contained herniated disc 4. Chronic pain lasting more than 3 months 5. Failed conservative medical management for over one month (medication and physical therapy) 6. Radicular pain is the primary complaint with minimal axial pain 7. NRS of > 3 (on 11-point NRS)

Exclusion criteria

Exclusion criteria: 1. Patient refusal 2. Atypical or bilateral radicular pain patterns 3. Axial pain 4. Cognitive impairment or language barriers that could impair the patients understanding and reporting of outcomes 5. Malignancy 6. Vertebral fractures 7. Multiple sclerosis 8. Connective tissue diseases 9. Infection 10. Pregnancy or breast-feeding 11. Prior Spinal surgery 12. Lumbar spine interventions in the last 6 months (epidural injections or PRF) 13. Coagulation disorder or anti-coagulant treatment 14. Psychiatric disorder 15. Allergy to local anesthetics or contrast medium 16. Dependent Personnel such as staff members, students or NCHDs 17. Pre-operative NSAID, corticosteroid, methotrexate, monoclonal antibody therapy or opioid therapy 18. Patients will be excluded from the study if appropriate nerve stimulation during the PRF procedure or pain relief (more than 50%) post DRG block are not achieved

Design outcomes

Primary

Measure	Time frame
The concentration of CD4+ T cells measured in the CSF at 3 months (T3) post PRF	—

Secondary

Measure	Time frame
Measured using cerebrospinal fluid and peripheral venous blood samples: 1. NK cell and CD8+ T cell numbers at baseline and T3 2. CD4+/CD8+ ratio at baseline and T3 3. CSF neuropeptide and cytokine concentrations at baseline and T3 Secondary outcomes (clinical): 4. Improvement in symptoms (on the Global Perceived Effect (GPE) - Likert Scale) at baseline and T3 5. Pain score (Numerical Rating Scale [NRS]) at baseline and T3 6. Global Perceived Effect (GPE) on Likert Scale and NRS at one hour (T1), one month (T2), and 6 months (T4) post PRF. 7. Quality of Life measured using the RAND-36 at T2, T3 and T4 8. Functional ability measured using the Oswestry Disability Index at T2, T3 and T4 9. Medication usage measured using the Medication Quantification Scale III at T2, T3 and T4 10. Adverse events at T1, T2, T3 and T4 11. Further interventions required at T2, T3 and T4	—

Measure

Time frame

Measured using cerebrospinal fluid and peripheral venous blood samples: 1. NK cell and CD8+ T cell numbers at baseline and T3 2. CD4+/CD8+ ratio at baseline and T3 3. CSF neuropeptide and cytokine concentrations at baseline and T3 Secondary outcomes (clinical): 4. Improvement in symptoms (on the Global Perceived Effect (GPE) - Likert Scale) at baseline and T3 5. Pain score (Numerical Rating Scale [NRS]) at baseline and T3 6. Global Perceived Effect (GPE) on Likert Scale and NRS at one hour (T1), one month (T2), and 6 months (T4) post PRF. 7. Quality of Life measured using the RAND-36 at T2, T3 and T4 8. Functional ability measured using the Oswestry Disability Index at T2, T3 and T4 9. Medication usage measured using the Medication Quantification Scale III at T2, T3 and T4 10. Adverse events at T1, T2, T3 and T4 11. Further interventions required at T2, T3 and T4

—

Countries

Ireland

Outcome results

None listed

Source: ISRCTN (via WHO ICTRP) · Data processed: Feb 4, 2026