Comparative Effectiveness of Two Different Approaches to Radiofrequency Ablation of Lumbar Medial Branch Nerves

Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorMilton S. Hershey Medical Center

About this trial

The purpose of this voluntary research study is to determine whether the parasagittal approach to lumbar medial branch (LMB) nerve radio frequency ablation (RFA) will have greater efficacy than the traditional approach to lumbar medial branch nerve radio frequency ablation.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Bilateral equally intense axial low back pain

Pain duration of ≥ 6 months

Three-day average NRS scores of ≥ 3/10

Age greater than 18 years

Disqualifiers

Radicular pain below the knee

Systemic infection or localized infection at the anticipated introducer entry site

Pregnancy

Allergy to Lidocaine

Trial design

Design model

Parallel

Treatments tested in this trial

  • Radiofrequency ablation of lumbar medial branch nerves.

    Procedure/Surgery

    Traditional approach: The electrode is introduced at a 15-20 degrees' ipsilateral oblique angle to the sagittal plane toward the junction of the superior articular process (SAP) and transverse process (TP) of the vertebral body to target the traversing medial branch nerve. Parasagittal (new) approach: The RF cannula is placed parasagittally and more dorsally. The remainder of the procedure does not differ from the traditional method.

Treatment groups

25 Participants
are divided into 2 treatment groups
Group A: Subjects with traditional approach on the right side and parasagittal approach on the left side.Active comparator 1 intervention
Group B: Subjects with traditional approach on the left side and parasagittal approach on the right side.Active comparator 1 intervention

Trial outcomes

Primary outcomes

1

The number of patients whose procedure was successful (gained 50% or more reduction in numeric rating pain (NRS) scores).

The patients will describe the pain intensity using NRS - 11-point numeric rating scale, with 0 means no pain, and 10 - the worst possible pain intensity.

Time frame
Baseline
2

The number of patients whose procedure was successful (gained 50% or more reduction in numeric rating pain (NRS) scores).

The patients will describe the pain intensity using NRS - 11-point numeric rating scale, with 0 means no pain, and 10 - the worst possible pain intensity.

Time frame
1 month post-procedure.
3

The number of patients whose procedure was successful (gained 50% or more reduction in numeric rating pain (NRS) scores).

The patients will describe the pain intensity using NRS - 11-point numeric rating scale, with 0 means no pain, and 10 - the worst possible pain intensity.

Time frame
6 months post-procedure.

Secondary outcomes

1

Oswestry Disability index (ODI)

10 questions assessing the functional impairment by the pain, using a 50 point scale, with 0 meaning no disability, and 50 meaning complete disability.

Time frame
Baseline
2

Oswestry Disability index (ODI)

10 questions assessing the functional impairment by the pain, using a 50 point scale, with 0 meaning no disability, and 50 meaning complete disability.

Time frame
1 month post-procedure.
3

Oswestry Disability index (ODI)

10 questions assessing the functional impairment by the pain, using a 50 point scale, with 0 meaning no disability, and 50 meaning complete disability.

Time frame
6 months post-procedure.

Other outcomes

1

Number of subjects who ceased requiring analgesia

The patients will self-report their analgesic consumption.

Time frame
Baseline
2

Number of subjects who ceased requiring analgesia

The patients will self-report their analgesic consumption.

Time frame
1 month post-procedure
3

Number of subjects who ceased requiring analgesia

The patients will self-report their analgesic consumption.

Time frame
6 months post-procedure

Sponsors and contacts

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