Radiofrequency Ablation for Low Back Pain

(ASTRAL Trial)

Not yet recruiting at 2 trial locations

Overseen By Research Study Coordinator

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: University of Washington

Must not be taking: Corticosteroids

Disqualifiers: Spine conditions, Lumbar fusion, Fibromyalgia, Unstable psychiatric, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: 1

Duration: Day of intervention

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests two types of radiofrequency ablation treatments (burning nerve tissue to reduce pain) for individuals with chronic low back pain. Researchers aim to evaluate the effectiveness of these treatments compared to a sham procedure (a fake treatment for comparison). Participants will be randomly assigned to one of three groups to receive either a standard treatment, a modified treatment, or the sham procedure. Individuals who have experienced low back pain for at least three months and have tried other treatments like physical therapy or massage may be suitable candidates for this study. As an unphased trial, this study provides a unique opportunity to contribute to innovative pain management research.

Will I have to stop taking my current medications?

The trial information does not specify whether you need to stop taking your current medications. It's best to discuss this with the study team or your doctor.

Is there any evidence suggesting that this trial's treatments are likely to be safe?

Research has shown that lumbar radiofrequency ablation (LRFA) is generally well-tolerated by patients. Studies using conventional electrodes for LRFA have demonstrated promising results, with 77% to 79% of patients experiencing significant pain relief and few reports of side effects. This indicates the treatment is relatively safe for many people.

For LRFA using multi-tined electrodes, studies have also reported positive outcomes, with about 41% of patients experiencing a meaningful reduction in pain. Although specific safety details weren't provided, the treatment's effectiveness suggests it is safe enough to continue in clinical trials.

Overall, both types of LRFA appear to have a good safety record based on current research. However, as with any medical treatment, individual experiences may vary, so discussing potential risks with a healthcare provider is important. ^{1 2 3 4 5}

Why are researchers excited about this trial's treatments?

Researchers are excited about lumbar radiofrequency ablation (LRFA) treatments for low back pain because they offer innovative approaches compared to standard pain relief methods like medication or physical therapy. Unlike traditional options, LRFA uses radiofrequency energy to target and deactivate specific nerve fibers responsible for transmitting pain signals. The two techniques being explored, using conventional electrodes (LRFA-C) and multi-tined electrodes (LRFA-M), potentially provide more precise and effective pain relief. This precision could mean longer-lasting results and fewer side effects, making them promising alternatives for managing chronic low back pain.

What evidence suggests that this trial's treatments could be effective for chronic low back pain?

This trial will compare two methods of lumbar radiofrequency ablation (LRFA) for reducing chronic low back pain. Research has shown that the traditional method using conventional electrodes (LRFA-C), which participants in this trial may receive, resulted in 77% to 79% of patients experiencing significant pain relief, with pain reduced by at least half over two years. Another treatment option in this trial is the newer method using multi-tined electrodes (LRFA-M), where about 41% of patients experienced similar pain reduction. Both methods use radio waves to create a small burn on the nerve, stopping it from sending pain signals. While results can vary, many patients find these treatments provide meaningful relief from their symptoms. ^{1 2 3 6 7}

Who Is on the Research Team?

Pradeep Suri, MD

Principal Investigator

University of Washington

Janna Friedly, MD

Principal Investigator

University of Washington

Are You a Good Fit for This Trial?

This trial is for individuals with chronic low back pain who have not found relief from other treatments. Participants must be adults and able to give informed consent. Specific medical conditions or previous treatments may disqualify some people, as determined by the study's criteria.

Inclusion Criteria

Able to read, speak, and understand English sufficient for informed consent purposes

Stated willingness to comply with all study processes and availability for the duration of the study, and provision of a signed and dated informed consent form

I experienced significant pain relief from two small local anesthetic injections for my lower back pain.

Exclusion Criteria

Cannot reach MBB targets with 11.9cm needle

Unstable psychiatric or terminal medical conditions that would limit study participation and the likelihood of follow-up for 12 months post-randomization

Pregnancy, being a prisoner, or having a prior formal diagnosis of cognitive impairment by a neuropsychologist or neurologist, confirmed by health record documentation

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants undergo lumbar radiofrequency ablation (LRFA) or a simulated procedure

Day of intervention

1 visit (in-person)

Follow-up

Participants are monitored for safety and effectiveness after treatment

12 months

What Are the Treatments Tested in This Trial?

Interventions

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

Trial Overview The ASTRAL Study is testing two types of lumbar radiofrequency ablation (LRFA) against a simulated procedure to see which is more effective for relieving chronic low back pain. Patients will be randomly placed in one of three groups: LRFA with conventional electrodes, LRFA with multi-tined electrodes, or a sham procedure.

How Is the Trial Designed?

Group I: LRFA-C Active Control 1 Intervention

Lumbar radiofrequency ablation with conventional electrodes

Group II: LRFA-M Active Control 1 Intervention

Lumbar radiofrequency ablation with multi-tined electrodes

Group III: Simulated LRFA Placebo Group 1 Intervention

Simulated lumbar radiofrequency ablation

Who Is Running the Clinical Trial?

University of Washington

Lead Sponsor

Trials

1,858

Recruited

2,023,000+

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

Collaborator

Trials

508

Recruited

1,090,000+

Citations

1. clinicaltrials.gov clinicaltrials.gov/study/NCT07222462

A Superiority Trial of Radiofrequency Ablation for Low Back ... The purpose of the ASTRAL Study is to evaluate the effectiveness of LRFA (Lumbar radiofrequency ablation) against a control procedure.

2. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC12085440/

Outcomes of Cooled Radiofrequency Ablation of Lumbar ... Complete pain remission was reported in 14.08% of effective procedures on 1062 patients. Average duration of improvement was 267.43 ± 393.18 ...

3. sciencedirect.com sciencedirect.com/science/article/pii/S2772594425000378

Assessment of real-world, prospective outcomes in patients ... Following RFA treatment at 1-month and out to 24-months, 77.0% and 79.0% of patients were observed to be treatment responders (i.e., ≥50% pain relief), ...

4. journals.lww.com journals.lww.com/ijpn/fulltext/2023/37020/two_arm_observational_study_to_assess_the_efficacy.5.aspx

Two-Arm Observational Study to Assess the Efficacy of... There was significant reduction in pain scores as well as improvement in quality of life in both the groups, but the difference between the two groups was not ...

5. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC10690866/

12 month outcomes Approximately 50% of the 42 participants treated with FJI reported treatment success at the 3-month follow-up. For the present power analysis, we used a ...

6. ichgcp.net ichgcp.net/clinical-trials-registry/NCT07222462

A Superiority Trial of Radiofrequency Ablation for Low Back ... The purpose of the ASTRAL Study is to evaluate the effectiveness of LRFA (Lumbar radiofrequency ablation) against a control procedure.

7. rapm.bmj.com rapm.bmj.com/content/49/3/184

Cooled radiofrequency ablation versus standard medical ... 52.3% of subjects in the cooled radiofrequency ablation group experienced >2 points or 30% pain relief and were deemed responders versus 4.3% of standard ...