Pulsed Radiofrequency Therapy on Peripheral Nerves Monitoring Pain, Quality of Life, Patient Satisfaction and Efficacy

NCT06270940 | Recruiting DMC

• 1 other identifier: 2023.0922
• Study Type: observational
• Target: 400
• Locations: 1 country
• Sites: 1

Brief Summary

Neuropathic pain is a chronic condition caused by damage to the somatosensory nervous system. The pain associated with neuropathic pain is often severe and debilitating, and can significantly interfere with the quality of life and daily functioning of affected patients. Current pharmacologic treatments, such as antidepressants, antiepileptics, and opioids, can offer only partial relief for 40-60% of patients, and are often accompanied by severe side effects. This has led to increasing interest in non-pharmacologic management options for neuropathic pain. One such promising treatment option is pulsed radiofrequency (PRF) treatment applied to the affected peripheral nerve in conjunction with local anesthetic and/or corticosteroid medication. Several studies, including case reports, retrospective studies, and small randomized controlled trials, have shown that PRF treatment to the affected peripheral nerve can be beneficial and effective for managing chronic peripheral neuropathic pain. Several peripheral neuralgias, such as thoracic postherpetic neuralgia, occipital neuralgia, pudendal neuralgia, meralgia paresthetica, painful shoulder, post-thoracotomy syndrome, and carpal tunnel syndrome, have been successfully treated with PRF. PRF treatment has garnered significant interest among ultrasound-skilled pain physicians because of its superior, safe, and non-destructive percutaneous approach to peripheral nerves, visualized by today's excellent visual ultrasound guidance. Our academic pain center performs approximately more than 1000 ultrasound-guided peripheral nerve blocks per year on a wide range of peripheral nerves. Moderate evidence for treating peripheral nerves with PRF treatment is available; however, PRF treatment settings such as voltage, number of cycles, and treatment duration vary, and it is not clear which setting contributes most substantially to pain reduction results. The aim of this prospective longitudinal observational data collection is to evaluate the efficacy of PRF treatment applied to peripheral nerves, to observe the clinical course of chronic peripheral neuropathic pain under conditions of routine clinical practice, and to link these observations with clinical outcomes.

Conditions

Neuropathic Pain

Outcome Measures

Primary Outcomes (8)

• Duration PRF

  Duration PRF: 4 or 8 minutes

  Procedure

• Type of PRF

  2 Hz of 5 Hz / 5 ms or 20 ms / Monopolar or bipolar / Voltage / Temperature / Resistance / Current

  Procedure

• Pain intensity

  Pain with NRS (Numeric Rating Scale): Min=0 / Max=10 / Low score is better

  Baseline, 6 weeks, 3 months, 6 months

• Health Related Quality of life

  EQ-5D-5L (EuroQol Quality of life) questionnaire: Index=Patient health state / Min=-0.446 / Max=1 / Higher is better / Patient self rated health: Min=0% / Max=100% / High scores are better

  Baseline, 6 weeks, 3 months, 6 months

• Patient Global Impression of Change: PGIC

  Patient Global Impression of Change: 7-point likert scale / Much better to much worse

  6 weeks, 3 months, 6 months

• Use of opioids

  Change of opioid medication (mg) / Min=0 mg / Max=not set / Lower values are better

  Baseline, 6 weeks, 3 months, 6 months

• PROMIS-29

  PROMIS: Profile-29 questionnaire; Standardized t-scoring with mean=50 and SD=10 in Dutch reference population

  Baseline, 6 weeks, 3 months, 6 months

• PROMIS Global-10

  ROMIS Global 10: Consists of ten (10) items that measure physical health, physical functioning, general mental health, emotional distress, satisfaction with social activities and relationships, ability to carry out usual social activities and roles, pain, fatigue and overall quality of life. Standardized t-scoring with mean=50 and SD=10 in Dutch reference population.

  Baseline, 6 weeks, 3 months, 6 months

Interventions

Pulsed Radiofrequency (PRF) Treatment PROCEDURE

PRF treatment maintains a temperature below 42°C and does not produce structural tissue damage around the needle. PRF exposure to the Dorsal Root Ganglion (DRG) induces c-Fos gene expression in the dorsal horn, which suggests a cellular response to the electric forces generated within the DRG. PRF has been found to relieve neuropathic pain by inducing long-term depression of synaptic transmission in the spinal cord, leading to a decrease in allodynia and hyperalgesia. It also modulates the inflammatory response in the injured area by decreasing the expression of pro-inflammatory cytokines, such as TNF-α, in the peripheral nerve and spinal cord, which is a major player in the development and maintenance of neuropathic pain. PRF is characterized by a 500 kHz current applied for 2 pulses per second, with each pulse lasting 20 milliseconds.

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

The population of this data collection consists of patients who will receive PRF treatment for chronic peripheral neuropathic pain (duration of pain ≥ 6 months).

You may qualify if:

• Adult patients ≥ 18
• Dutch speaking
• Chronic peripheral neuropathic pain lasting ≥ 6 months with mean NRS pain score of ≥ 4
• Patients who are scheduled for an ultrasound guided PRF treatment on a peripheral nerve
• Willing and able to sign consent

You may not qualify if:

• \- Inability to complete the questionnaires

Sponsors & Collaborators

• Amsterdam UMC, location VUmc: lead

Study Sites (1)

Amsterdam UMC

Amsterdam, 1081 HV, Netherlands

RECRUITING

MeSH Terms

Conditions

Neuralgia

Interventions

Prolactin-Releasing Hormone; Therapeutics

Condition Hierarchy (Ancestors)

Peripheral Nervous System Diseases; Neuromuscular Diseases; Nervous System Diseases; Pain; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Hypothalamic Hormones; Peptide Hormones; Hormones; Hormones, Hormone Substitutes, and Hormone Antagonists; Neuropeptides; Peptides; Amino Acids, Peptides, and Proteins; Nerve Tissue Proteins; Proteins

Study Officials

• Monique Steegers, Prof

  Amsterdam UMC

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Katrin Stoecklein, Dr

CONTACT

0031 20 444 386; k.stoecklein@amsterdamumc.nl

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Target Duration: 6 Months
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Anesthesiologist

Study Record Dates

• First Submitted: February 2, 2024
• First Posted: February 21, 2024
• Study Start: March 4, 2024
• Primary Completion: October 31, 2025
• Study Completion: February 28, 2026
• Last Updated: April 24, 2024

Record last verified: 2024-04

Data Sharing

• IPD Sharing: Will not share

Locations

NL (1)