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

Not Applicable

Suspended

• Conditions: Chronic, radicular, lumbosacral pain; Nervous System Diseases; Radiculopathy

• Registration Number: ISRCTN60691016
• Lead Sponsor: Trinity Translational Medicine Institute

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2020-01-01
• Last Update Posted: 5 January 2021
• Study Completion: 2021-12-31

Recruitment & Eligibility

• Status: Suspended
• Sex: All
• Target Recruitment: 10

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

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

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

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