CompletedNot Applicable

Medial Branch Radiofrequency Ablation and Lumbar Multifidi

United States4 participantsStarted 2017-01-01

Plain-language summary

The purpose of this study is to evaluate the effects of lumbar medial branch radiofrequency ablation (RFA) on lumbar multifidi muscle size and clinical spinal stability. Specifically, this study is designed to highlight the comparison of multifidi muscle architecture using ultrasound imaging (USI) and MRI before and after lumbar medial branch RFA. This study will also include a commonly utilized functional assessment of the lumbar spine to evaluate the effects of RFA on lumbar spinal stability.

Who can participate

Age range

18 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion criteria are: * Aged over 18 years * Presence of lumbar spondylosis or facet arthropathy (as determined by a radiologist) \*Unilateral back pain without radicular symptoms * Positive physical findings for facet mediated pain (pain with lumbar extension and rotation to affected side) * Ability to complete outcome measure forms. Exclusion criteria are: * Prior spinal surgery * Prior RFA procedures * Pregnancy * Contraindications to MRI * Presence of therapeutic anti-coagulation, medical co-morbidities that would interfere with the ability to perform the procedure safely * Presence of neurologic changes * Active tobacco smoking history * Presence of active litigation * Presence of open workers compensation case

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

Percentage Change in Volume of multifidus muscle on MRI

Timeframe: Up to 3 months after radiofrequency ablation procedure

Percentage Change in Cross Sectional Area of Multifidi

Timeframe: Up to 3 months after radiofrequency ablation procedure

Trial details

NCT IDNCT03744260

SponsorColumbia University

Sponsor typeOTHER

Study typeOBSERVATIONAL

Primary completion2020-06-30

View on ClinicalTrials.gov More Spondylosis trials