A randomised, sham-controlled, double-blind, multicenter clinical trial to evaluate the percutaneous pulsed radiofrequency treatment at the dorsal root ganglion

A randomised, sham-controlled, double-blind, multicenter clinical trial to evaluate the percutaneous pulsed radiofrequency treatment at the dorsal root ganglion - PRF at the DRG

Status

Active, not recruiting

Phases

Unknown

Study type

Interventional

Source

NL-OMON

Registry ID

NL-OMON38908

Enrollment

Registered

2013-06-06

Start date

2013-07-01

Completion date

Unknown

Last updated

2024-04-29

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

Conditions

radiating Radicular

Interventions

group 1 (treatment group): percutaneous pulsed radiofrequency treatment (45 V, 2 Hz, 20 ms, 4 minutes, maximum 42º C) at the lumbar and sacral dorsal root ganglion

group 2 sham-operated group (same procedure as in group 1 except pulsed radiofrequency). Both groups will receive graded activity physiotherapy.

Eligibility

Age

18 Years to 99 Years

Inclusion criteria

Inclusion criteria: 1) Age 18 years or older 2) Anamnesis and physical investigation suggestive of lumbosacral radicular pain for more than 3 months 3) Decrease in NRS of 2 or more / 10 on diagnostic block at the DRG

Exclusion criteria

Exclusion criteria: 1) Presence of red flags: possible fracture (major trauma, minor trauma in elderly or osteoporotic), possible tumor or infection (age >50 or

Design outcomes

Primary

Measure	Time frame
Numerical Rating Scale (NRS).	—

Secondary

Measure	Time frame
Pain: Chronic Pain Acceptance Questionnaire (CPAQ), Four-Dimensional Symptom Questionnaire (4DSQ), Multidimensional Pain Inventory (MPI-DLV); Global Perceived Effect (GPE). Disability: Oswestry Disability Index (ODI); Generic health status: Rand-36; Kinesiophobia: Tampa Scale for Kinesiophobia (TSK); Coping: Pain Coping Inventory (PCI), Pain Cognition List (PCL-2003). Costs of intervention.	—

Countries

Netherlands

Outcome results

None listed

Source: NL-OMON (via WHO ICTRP)