Analgesic Effect of Different Positions and Canulae on Medial Branch Radiofrequency Denervation for Lumbar Zygapophyseal Joint Pain (EARL)

Instituto de Investigación Hospital Universitario La Paz

Status: Completed

Conditions: Lumbar Medial Branch Neurotomy; Lumbar Facet Joint Pain

Treatments: Other: PAIN REDUCTION ON VAS/NRS

Study type: Interventional

Funder types: Other

Identifiers

NCT03491618

HULP5017

Details and patient eligibility

About

Prospective study to analyse pain reduction with two types of canulae and two types of placements for lumbar medial branch radiofrequency denervation.

Full description

Patients who suffer from lumbar zygapophyseal joint pain often receive radiofrequency medial branch denervation as treatment. Many types if canulae exist, and many types of placing them in relation to the Medial Branch nerves (MB). The EARL study tries to compare the analgesic effect of thin canulae (22 gauge) placed perpendicular to MB to thicker canulae (18 gauge) placed parallel to MB.

Enrollment: 43 patients

Sex: All

Ages: 18 to 80 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Low back pain of > 3 months
• 18-80 years
• VAS or NRS>6
• Positive controlled block

Exclusion criteria

• Pregnancy
• Psichiatric disorders
• Not being able to fulfil questionnaires
• Body Mass Index>35
• Labor Litigation
• Negative or non conclusive controlled block
• Failed Back Surgery Syndrome

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

---

43 participants in 2 patient groups

PARALLEL

Active Comparator group

Description:

Thick canulae (18 gauge) placed parallel to Medial Branch under fluoroscopy.

Treatment:

Other: PAIN REDUCTION ON VAS/NRS

PERPENDICULAR

Active Comparator group

Description:

Thin canulae (22 gauge) placed perpendicular to Medial Branch under fluoroscopy.

Treatment:

Other: PAIN REDUCTION ON VAS/NRS