The Effect of Sensory Stimulation Threshold on the Efficacy of Pulsed Radiofrequency Applied to the Dorsal Root Ganglion in Patients with Chronic Lumbar Radicular Pain

Trial statusNot yet recruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18-80
SponsorAnkara University

About this trial

Lomber dorsal root ganglion pRF is an interventional treatment options in the treatment of lumbar radicular pain. The goal of this study is to investigate the effect of sensory threshold outcomes on pain severity during dorsal root ganglion pulsed radiofrequency (DRG-pRF). It will also learn effects about disability due to chronic LRP. The main questions it aims to answer are:

Does lower sensory threshold result in lower pain scores and chronic LRP related disability?

Participants will:

Take DRG-pRF procedure for 4 minutes. Visit the clinic at 1. and 3. month for questionnaries.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

None

Disqualifiers

None

Trial population

Candidates who visited algology clinic of Ankara University Medicine Faculty Hospitals to DRG-pRF prodecure for chronic LRP.

Trial design

Design model

Case-only

Time perspective

Prospective

Treatments tested in this trial

  • Dorsal Root Ganglion Pulsed Radiofrequency

    Procedure/Surgery

    Using C-arm fluoroscopy, a 22G, 10 cm RF needle with a 5 mm active tip will be directed from lateral to medial towards the vertebral foramen. Once the needle reaches the lateral edge of the pedicle shadow, the C-arm will be adjusted to a lateral view to confirm that the needle is located at the craniodorsal portion of the intervertebral foramen. Sensory stimulation will be delivered through the RF generator at 50 Hz, and paresthesia will be sought in the corresponding dermatome at values between 0.4-0.8 mA. After achieving paresthesia, motor stimulation at 2 Hz will be applied, and the location near the DRG will be confirmed if motor stimulation is not elicited at values less than 1.5 times the sensory threshold. Pulsed RF will then be applied for 4 minutes at a setting of 45 V, 20 ms pulse width, and 2 Hz frequency. Following the application, needle will be directed slightly anterior and after appropriate contrast flow, dexamethasone will be injected.

Treatment groups

150 Participants
are divided into 1 treatment group
Group A: Dorsal Root Ganglion Pulsed Radiofrequency1 intervention

Trial outcomes

Primary outcomes

1

Postprocedure pain severity at 3th month

Severity of pain will be assessed with Numeric Rating Scale (NRS-11) at 3 months after interventions. NRS-11 is a 11 point likert type scale. Higher scores represent more severe pain.

Time frame
From procedure to 3 months after prodecure

Secondary outcomes

1

Postprocedure pain severity at 30. min

Severity of pain will be assessed with Numeric Rating Scale (NRS-11) at 30. min after interventions at bedside. NRS-11 is a 11 point likert type scale. Higher scores represent more severe pain.

Time frame
From procedure to 30 minustes after procedure
2

Postprocedure first month pain severity

Severity of pain will be assessed with Numeric Rating Scale (NRS-11) at 1 month after interventions. NRS-11 is a 11 point likert type scale. Higher scores represent more severe pain.

Time frame
From procedure to 1 month after procedure
3

Postprocedure first month OSWESTRY scores

Disability will be assessed with OSWESTRY Diasability Index at 1 month. OSWESTRY measures pain related lumbar disability. It has 0 minimum and 100 maximum value. Lower scores represent better outcomes.

Time frame
From procedure to 1 month after procedure
4

Postprocedure 3th month OSWESTRY scores

Disability will be assessed with OSWESTRY Diasability Index at 3 month. OSWESTRY measures pain related lumbar disability. It has 0 minimum and 100 maximum value. Lower scores represent better outcomes.

Time frame
From procedure to 3 month after procedure

Other outcomes

Locations

This trial has no locations.

Sponsors and contacts

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