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NCT Number: NCT02478437

A Trial of Cooled Radiofrequency Ablation of Medial Branch Nerves for theTreatment of Lumbar Facet Syndrome

This study is being done to determine whether cooled radiofrequency ablation (CRFA) on the medial branch nerves of the lumbar facet joint is effective for the treatment of low back pain. CRFA blocks the nerves that carry pain signals from joints in the lower back such that the brain does not receive the message that the low back is in pain. This technique is commonly performed by burning these nerves rather freezing them, but it is suspected that freezing them results in better pain relief. The CRFA blocks has been shown to effectively treat sacroiliac joint pain (a joint in the pelvis), which is another reason that it is suspected that CRFA will be effective when treating pain related to facet joints in the low back. We are performing this study in order to determine if that is the case.

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Key information

Conditions

Low Back Pain Back Pain Neurologic Manifestations Pain Pathological Conditions, Signs and Symptoms Signs and Symptoms

Age range

18 year–79 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

Anesthesiology Pain Managment Center

Chicago, Illinois, 60611, United States

About this study

The CRFA blocks has been shown to effectively treat sacroiliac joint pain (a joint in the pelvis), which is another reason that it is suspected that CRFA will be effective when treating pain related to facet joints in the low back. We are performing this study in order to determine if that is the case.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Patients with lumbar facet syndrome pain who would undergo treatment by lumbar medial branch radiofrequency ablation.
  • Low back pain for at least 6 months.
  • Pain resistant to conventional therapy including NSAIDs, opioids, muscle relaxants, oral steroids, physical therapy or chiropractic care.
  • Pain diagram suggesting possibility of facet-mediated pain.
  • Referred pain when present not beyond the knee.
  • Positive response to at least 1 set of diagnostic intra-articular facet injections or medial branch blocks, defined as > 75% reduction in pain following diagnostic blocks with local anesthetic (0.5mL of 0.5% bupivacaine OR 0.5 mL of 2% lidocaine).

Exclusion criteria

  • Focal neurologic signs or symptoms.
  • Radiologic evidence of a symptomatic herniated disc or nerve root impingement related to spinal stenosis.
  • Previous radiofrequency ablation treatment for similar symptoms.
  • Patient refusal.
  • Lack of consent.
  • Active systemic or local infections at the site of proposed needle and electrode placement.
  • Coagulopathy or other bleeding disorder, current use of anticoagulants or anti-platelet medications.
  • Allergy to medications being used for injection procedures (contrast dye, local anesthetic, IV sedative).
  • Inability to read English, communicate with staff, or participate in follow up.
  • Pregnancy.
  • Cognitive deficit.
  • Negative response to diagnostic intra-articular facet injections or medial branch blocks, defined as < 75% reduction in pain following diagnostic blocks with local anesthetic (0.5mL of 0.5% bupivacaine OR 0.5 mL of 2% lidocaine).
  • Daily opiate analgesic use more exceeding 3 months prior to study inclusion.
  • Unstable medical or psychiatric illness.

Treatment and study plan

Conventional radiofrequency ablation (RFA)

Procedure

A conventional RFA electrode with a 10mm active tip will be used. RFA lesions will be performed for 90 seconds with the maximum electrode temperature raised to 80°C.

Cooled Radiofrequency Ablation (CRFA)

Procedure

Following 18G C-RFA electrode positioning, 1cc of 2% lidocaine will be injected through the introducer needle for anesthesia during the ablation. The maximum electrode temperature is 60°C.

Primary outcomes

  1. Pain improvement

    Time frame: 6 months post-procedure

    Percent of participants who reported 50% or greater improvement in pain

Secondary outcomes

  1. Global pain score

    Time frame: 1 month, 3 months, 6 months and 12 months post procedure

    Global Numeric Rating Scale (NRS, 0 is no pain and 10 is worst pain imaginable)

  2. McGill Pain Questionnaire (MPQ)

    Time frame: 1 month, 3 months, 6 months and 12 months post procedure

    Scores are tabulated by summing values associated with each word; scores range from 0 (no pain) to 78 (severe pain).

  3. Pain Anxiety Symptom Scale short form (PASS-20)

    Time frame: 1 month, 3 months, 6 months and 12 months post procedure

    The PASS-20 assesses 4 factorially distinct components of pain-related anxiety. Each question is in a form of a 6-point Likert Scale anchored from 0 (never) to 5 (always).

  4. Center for Epidemiologic Studies Depression short form index (CESD-10)

    Time frame: 1 month, 3 months, 6 months and 12 months post procedure

    The possible range of the 10-item scale is 0 to 30, and a cut off score of ten or higher indicates the presence of significant depressive symptoms. Subjects responded to each item of the scale by rating the frequency of each mood or symptom ''during the past week'' on a four-point scale.

Sponsors and collaborators

Lead sponsor

Northwestern University

Other

Collaborators

  • American Pain Society

Registry information

Official study title

A Prospective Trial of Cooled Radiofrequency Ablation of Medial Branch Nerves for the Treatment of Lumbar Facet Syndrome

Acronym: STU00097239

Important dates

Study start
2015
Primary completion
2018
Study completion
2018
First posted
Jun 23, 2015
Registry last updated
Sep 6, 2018

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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