Evaluation of Multi-Tined Expandable Electrode (MEE) Efficacy and Safety in Treatment of Lumbar Facet Arthropathy by Radiofrequency Neurotomies Compared to Conservative Medical Management.

Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorUniversity of Kansas Medical Center

About this trial

The purpose of this study is to better understand how people feel after a radiofrequency ablation standard of care surgery using a different type of needle (multi-tined expandable electrode/MEE) in comparison to receiving conventional medical management (CMM) techniques.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Age > 18 years old.

Patients with pain lasting at least 6 months.

Patients with history of non-radiating low back pain.

Patient who had two diagnostic medial branch blocks (MBB) with significant (>50%) improvement on both injections.

Disqualifiers

Patient with low back pain with radiation or involvement of pain going into their legs below their knees.

Patient did not receive satisfactory relief from diagnostic MBB (<50% relief).

Patient is unable to receive radiation exposure.

Patient is currently pregnant.

Trial design

Design model

Parallel

Treatments tested in this trial

  • Radiofrequency Ablation with MEE

    Procedure/Surgery

    RFA will be performed in the usual fashion utilizing the MEE instead of the RFA needles routinely used at each institution.

  • Conventional Medical Management

    Behavioral

    Conventional medical management (CMM), which may include physical therapy, home exercise programs, pain medication, and other conservative therapies such as back brace, walking aid, and chiropractic care.

Treatment groups

50 Participants
are divided into 2 treatment groups
Group A: Radiofrequency ablation (RFA) with MEEActive comparator 1 intervention
Group B: Conventional Medical Management (CMM) Treatment OnlyActive comparator 1 intervention

Trial outcomes

Primary outcomes

1

The mean visual analog scale (VAS) between the two group

will be compared using an independent samples t-test

Time frame
12 months

Secondary outcomes

1

Observe the incidence of complications associated with MEE while utilizing this device

Number of complications will be analyzed using Independent samples T-Test if there is a normal distribution of complications. In the event of a binary outcome for complications, Chi-square Test will be used.

Time frame
12 months

Other outcomes

Sponsors and contacts

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