Pulsed radiofrequency treatment of the lumbar dorsal root ganglion for patients with chronic lumbosacral radicular pain.

Recruitment & Eligibility

Status: Completed

Sex: Not specified

Target Recruitment: 30

Inclusion Criteria

* Symptoms more than 3 months;
* Pain radiating into the leg, up to the hallux (big toe) (L5) or little toe (S1),
* The pain in the leg dominates over a possible lumbalgia, the average pain in the leg measured 3 times a day, at predefined time points, over 4 consecutive days prior to inclusion should be more than 5 (VAS 10-point scale) 9,
* Pattern of radiation suggestive for L5 or S1 pathology 49,50,
* One or more positive neurological tests of nerve root tension or neurological deficit 51 (straight leg raising test (SLRT), contralateral SLRT, motor block during SLRT and passive cervical flexion, motor reaction during passive cervical flexion while bending forward in standing position),
* Capable of understanding the information relative to the treatment and procedure and willing to provide informed consent,
* Capable of understanding and filling-out the questionnaires necessary for evaluation of the treatments,
* Patients having undergone low back surgery like discectomy with or without laminectomy are allowed to participate in the study.

Exclusion Criteria

* Patients younger than 18 years,
* Malignant disorder or currently under treatment for a malignant disorder,
* Previous lumbar fractures,
* Proven myelum lesion or abnormalities in the central neurological structures,
* Systemic or connective tissue diseases,
* Diabetes mellitus type I,
* Multiple sclerosis,
* Coagulation disorders,
* Pregnancy,
* Pain Catastrophizing Scale > 45. When the patient has a higher score he/she will first be referred to a psychologist for consultation 52,
* Leg pain due to localized hip or knee pathology,
* Patients with a pacemaker or neurostimulator,
* Patients previously treated with RF or PRF of the lumbar DRG.

Study & Design

Study Type: Interventional

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
<p>The primary research question is to evaluate the extent of additional pain<br /><br>reduction induced by PRF, compared with the control group. Following evaluation<br /><br>tools are used: Visual Analogue Scale 8, Global Perceived Effect on Likert<br /><br>Scale, consumption of pain medication, neuropathic pain scales: LANSS and<br /><br>DN-4. </p><br>

Secondary Outcome Measures

Name	Time	Method
<p>Secondary parameters are quality of life measured by RAND 36, disability<br /><br>measured with the Oswestry disability Index.<br /><br>A sub-analysis will be conducted to evaluate a potential correlation between<br /><br>diagnostic block and outcome of PRF treatment. Another sub-analysis will be<br /><br>conducted to evaluate a potential correlation between the neurological tests<br /><br>described in this study and the outcome of PRF treatment. </p><br>