An investigation of the effect of radiofrequency electric field stimulation of spinal nerves on the contents of spinal fluid in patients with chronic radicular pain

An investigation of the effect of pulsed radiofrequency treatment (PRF) of the dorsal root ganglion (DRG) on cerebrospinal fluid cellular and neuropeptide concentrations with clinical outcome correlation in patients with chronic cervical and lumbosacral radicular pain

Status

Active, not recruiting

Phases

Unknown

Study type

Interventional

Source

ISRCTN

Registry ID

ISRCTN42690092

Enrollment

Registered

2019-10-22

Start date

2015-12-01

Completion date

Unknown

Last updated

2019-12-10

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

Conditions

Chronic radicular pain Musculoskeletal Diseases Radiculopathy

Interventions

Chronic radicular pain is a central neuroimmune phenomenon. Pulsed radio frequency treatment (PRF) to the appropriate level dorsal root ganglion is an effective treatment however its mechanism of acti

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: 1. Age range 18-60 years 2. Unilateral monosegmental radicular pain in the cervical or 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 9. Connective tissue diseases 10. Infection 11. Pregnancy or breast feeding 12. Prior spinal surgery 13. Lumbar spine interventions in the last 6 months (epidural injections or PRF) 14. Coagulation disorder or anti-coagulant treatment 15. Psychiatric disorder 16. Allergy to local anesthetics or contrast medium 17. Pre-operative NSAID, corticosteroid, methotrexate, 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
1. Number of neuroimmune cells (CD4+ T Cell, CD8+ T Cells, and Natural Killer cells) in the cerebrospinal fluid following PRF to the DRG 2. Neuropeptides and cytokines commonly associated with chronic pain conditions following PRF (BDNF, Substance P, NGF, MCP-1, VEGF, IFN-gamma, IL-1, IL-6, TNF)	—

Secondary

Measure	Time frame
Assessments will be made at the following time points: Immediately before the procedure (T0) 1 hour after the procedure (GPE and NRS only) (T1) 1 month post procedure (T2) 3 months post procedure (T3) 6 months post procedure (T4) 1. CSF related: 1.1. NK cell and CD8+ T cell numbers at T3 1.2. CD4+/CD8+ ratio at T3 1.3. CSF neuropeptide and cytokine concentrations at T3 2. Clinical: 2.1. Success of PRF treatment at T3. Clinical success is defined as at least a 50% improvement in symptoms (score of 6 or 7 on the Likert Scale), and a reduction of at least 2-points on the NRS score 2.2. Global Perceived Effect (GPE) on Likert Scale and pain score (NRS) at one hour (T1), one month (T2), and 6 months (T4) post PRF 2.3. Changes in Quality of Life (RAND-36) at T2, T3, and T4 2.4. Functional ability (Oswestry Disability Index) at T2, T3, and T4 2.5. Medication usage (Medication Quantification Scale III) at T2, T3, and T4 2.6. Adverse events at T1, T2, T3, and T4 2.7. Further interventions required at T2, T3, and T4	—

Measure

Time frame

Assessments will be made at the following time points: Immediately before the procedure (T0) 1 hour after the procedure (GPE and NRS only) (T1) 1 month post procedure (T2) 3 months post procedure (T3) 6 months post procedure (T4) 1. CSF related: 1.1. NK cell and CD8+ T cell numbers at T3 1.2. CD4+/CD8+ ratio at T3 1.3. CSF neuropeptide and cytokine concentrations at T3 2. Clinical: 2.1. Success of PRF treatment at T3. Clinical success is defined as at least a 50% improvement in symptoms (score of 6 or 7 on the Likert Scale), and a reduction of at least 2-points on the NRS score 2.2. Global Perceived Effect (GPE) on Likert Scale and pain score (NRS) at one hour (T1), one month (T2), and 6 months (T4) post PRF 2.3. Changes in Quality of Life (RAND-36) at T2, T3, and T4 2.4. Functional ability (Oswestry Disability Index) at T2, T3, and T4 2.5. Medication usage (Medication Quantification Scale III) at T2, T3, and T4 2.6. Adverse events at T1, T2, T3, and T4 2.7. Further interventions required at T2, T3, and T4

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Countries

Ireland

Outcome results

None listed

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