A Superiority Trial of Radiofrequency Ablation for Low Back Pain

ConditionChronic Low Back Pain (CLBP)

Trial statusRecruiting

Trial phaseNot applicable

Trial typeInterventional

Biological sexAll

Age18+

SponsorUniversity of Washington

About this trial

The purpose of the ASTRAL Study is to evaluate the effectiveness of LRFA (Lumbar radiofrequency ablation) against a control procedure. The ASTRAL Study will enroll individuals with chronic low back pain (CLBP) and randomly assign them to one of three groups: lumbar radiofrequency ablation using conventional electrodes placed parallel to the medial branch nerves (LRFA-C), lumbar radiofrequency ablation using multi-tined electrodes placed perpendicular to the medial branch nerves (LRFA-M), or a simulated radiofrequency ablation procedure.

Eligibility criteria

Qualifiers

Age ≥18 years

CLBP of duration ≥ 3 months. Low back pain is defined as occurring between the lower posterior margin of the rib cage and the horizontal gluteal fold.

Low back pain intensity numerical rating scale (NRS) ≥ 4 with one of the following prior to LRFA: 1) Current low back pain intensity, 2) Average pain over past 7 days, OR 3) Pain intensity without specification of recall period

Has had conservative treatments for CLBP (physical therapy, exercise therapy, spinal manipulation, massage, acupuncture, etc.)

Disqualifiers

CLBP attributed primarily to specific spine-related conditions (radiculopathy, lumbar spinal stenosis, spinal instability), 'red flag' conditions (infection / malignancy / fracture), and/or inflammatory arthritis (RA, SpA, etc.)

Prior LRFA

Prior lumbar facet joint (intra-articular or medial branch nerve) corticosteroid injections (past 6 months)

Surgery involving one or more of spinal levels where LRFA is to be performed, in the past 2 years

Trial design

Treatments tested in this trial

Lumbar radiofrequency ablation with conventional electrodes (LRFA-C)
Lumbar radiofrequency ablation with multi-tined electrodes (LRFA-M)
Simulated lumbar radiofrequency ablation

Treatment groups

300 Participants

are divided into 3 treatment groups

Sponsors and collaborators

University of Washington

Lead sponsor

National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS)

Collaborator

Source ClinicalTrials.gov