Lumbar Medial Branch Blocks for Facet Joint Pain

(OMEGA Trial)

Overseen by Benedict J Alter, MD, PhD

Age: 18+

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Academic

Recruiting

Sponsor: University of Pittsburgh

Disqualifiers: Spine surgery, Worker's compensation, others

No Placebo Group

Trial Summary

What is the purpose of this trial?

This trial studies how a nerve-numbing injection in the lower back helps reduce chronic pain. It focuses on patients with ongoing low back pain and examines how well this treatment works by blocking pain signals.

Will I have to stop taking my current medications?

The trial does not specify if you need to stop taking your current medications, but it excludes those who have started new pain or psychiatric treatments within 2 weeks of enrollment. This might suggest that changes in medication close to the trial start are not allowed.

What data supports the effectiveness of the treatment Lumbar Medial Branch Blocks for Facet Joint Pain?

Research shows that cryoanalgesia, a technique used in this treatment, is effective for long-term pain relief by freezing nerves, which has been successfully applied to various types of pain, including low back pain related to lumbar facet joint issues. Additionally, ultrasound-guided lumbar facet nerve blocks have been shown to be accurate, which can improve the precision and effectiveness of the treatment. ^{1 2 3 4 5}

Is lumbar medial branch block for facet joint pain safe for humans?

The research does not provide specific safety data for lumbar medial branch blocks, but it does mention that lidocaine, used in similar procedures, can cause changes in sensation without significant adverse effects. This suggests that similar treatments may be generally safe, but specific safety data for lumbar medial branch blocks is not available in the provided studies. ^{6 7 8 9 10}

How is the lumbar medial branch block treatment for facet joint pain different from other treatments?

Lumbar medial branch blocks are unique because they specifically target the nerves that supply the facet joints, using a precise ultrasound-guided technique to diagnose and potentially treat facet joint pain. This method is different from other treatments as it focuses on blocking nerve signals to relieve pain, and the use of ultrasound guidance can improve accuracy and reduce the need for multiple needle placements. ^{4 5 11 12 13}

Research Team

Benedict J Alter, MD, PhD

Principal Investigator

University of Pittsburgh

Eligibility Criteria

This trial is for adults over 18 with chronic low back pain daily for at least 3 months, who are scheduled for a lumbar medial branch block (MBB) at UPMC Pain Management clinics. Participants must be able to understand English, complete questionnaires, and handle study-related phone calls. Those with past spine surgery at the MBB level or active compensation claims can't join.

Inclusion Criteria

I can take calls related to the study.

My lower back pain is more than 3 out of 10 in intensity.

My cognitive function is above the minimum required level.

Exclusion Criteria

I have had spine surgery in my lower back.

I have not started new pain or psychiatric treatments in the last 2 weeks.

You are currently involved in worker's compensation or legal claims.

Trial Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Quantitative Sensory Testing

Participants undergo quantitative sensory testing to measure CNS pain modulation before the lumbar medial branch block

1 day

1 visit (in-person)

Treatment

Participants receive a lumbar medial branch block as part of routine clinical care

1 day

1 visit (in-person)

Follow-up

Participants report low back pain intensity in a pain diary and are monitored for changes in pain perception

16 hours

Treatment Details

Interventions

• Computer Tasks (Behavioral Intervention)
• Cutaneous Probe (Behavioral Intervention)
• Quantitative Sensory Testing (Behavioral Intervention)

Trial Overview The study investigates how the central nervous system's pain inhibition relates to relief after a lumbar MBB procedure. It involves using a cutaneous probe, quantitative sensory testing, and computer tasks to assess this relationship in participants undergoing the treatment.

Participant Groups

Group I: Quantitative Sensory Testing Experimental Treatment 3 Interventions

Participants with chronic low back pain and a scheduled lumbar medial branch block undergo quantitative sensory testing.

Who Is Running the Clinical Trial?

University of Pittsburgh

Lead Sponsor

Trials

1,820

Recruited

16,360,000+

David Apelian

University of Pittsburgh

Chief Executive Officer since 2019

PhD in Molecular Biology from Rutgers University, MD from the University of Medicine and Dentistry of New Jersey, MBA from Quinnipiac University

Pamela D. Garzone

University of Pittsburgh

Chief Medical Officer

PhD in Clinical Science from the University of Pittsburgh

Findings from Research

A new experimental setup was developed to reliably compare the sizes of radiofrequency (RF) and cryolesions, which are used to interrupt nerve supply for pain relief, using specific agar gel to simulate tissue conditions.

The setup demonstrated reproducibility in measuring lesions and provided better visual observation with smaller containers, although it cannot fully replicate the complexities of living tissue.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The gel box - a testing device for the characterization of cryo- and radiofrequency lesions employed in interventional pain therapy. Birkenmaier, C., Terzis, A., Wegener, B., et al.[2019]

In a pilot study involving 21 patients with refractory phantom limb pain, image-guided percutaneous nerve cryoablation demonstrated a 100% technical success rate and was found to be a feasible and safe procedure.

Patients experienced significant reductions in pain intensity, from a mean score of 6.2 to 2.0, and improvements in disability scores, from 11.3 to 3.3, indicating that this treatment may be an effective option for managing phantom limb pain.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Percutaneous Image-Guided Cryoablation for the Treatment of Phantom Limb Pain in Amputees: A Pilot Study. Prologo, JD., Gilliland, CA., Miller, M., et al.[2022]

Cryoneuroablation, or cryoanalgesia, is an effective long-term pain relief technique that works by freezing nerves to create a conduction block, similar to local anesthetics, and is used for various types of pain including craniofacial, abdominal, and lower back pain.

This method causes vascular damage and nerve disruption while preserving the myelin sheath, allowing for targeted pain management in conditions like trigeminal neuralgia and post-thoracotomy pain, making it a valuable option in interventional pain management.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Cryoanalgesia in interventional pain management. Trescot, AM.[2022]

The new ultrasound-guided technique for lumbar facet nerve blocks demonstrated a high accuracy rate, with 90% of needle tips located at the exact target point and a simulated block success rate of 94% based on contrast dye spread.

The study, involving 50 bilateral approaches in five cadavers, found that while some contrast spread was abnormal (e.g., paraforaminal or epidural), all approaches were still successful in reaching the target area, indicating the method's reliability compared to traditional fluoroscopy-guided techniques.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Ultrasound-guided lumbar facet nerve block: accuracy of a new technique confirmed by computed tomography. Greher, M., Kirchmair, L., Enna, B., et al.[2019]

In a study involving 8 subjects, lumbar epidural lidocaine was shown to effectively cause a differential neural blockade, as indicated by changes in current perception thresholds (CPTs) at specific body sites, particularly at the umbilicus and knee.

While lidocaine increased CPTs and significantly decreased sensations like touch, pinprick, and cold at the umbilicus and knee, it did not affect sensory measurements at the mastoid, suggesting targeted effects of the anesthetic.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Quantitative assessment of differential sensory blockade after lumbar epidural lidocaine. Tay, B., Wallace, MS., Irving, G.[2022]

A study of 15 patients with local freezing cold injuries showed that abnormal sensory thresholds for vibration, warmth, and cold perception can be detected 4 months after the injury, indicating lasting neurosensory effects.

Symptoms related to cold injuries, such as pain when exposed to cold and persistent cold sensations, were reported by patients both 4 months and 4 years after the injury, suggesting long-term consequences of freezing cold injuries.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Neurosensory sequelae assessed by thermal and vibrotactile perception thresholds after local cold injury. Carlsson, D., Burström, L., Lilliesköld, VH., et al.[2021]

Cryotherapy significantly reduced nerve conduction velocity (NCV) by 32.8% when the ankle skin temperature was lowered to 10 degrees Celsius, indicating a physiological change in nerve function.

The application of cryotherapy increased pain threshold (PTH) and pain tolerance (PTO) in the treated ankle, suggesting that the reduction in NCV may help enhance pain management during physical therapy.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The effect of cryotherapy on nerve conduction velocity, pain threshold and pain tolerance. Algafly, AA., George, KP.[2022]

In participants with low back pain (LBP), digitally tender points (DTPs) showed significantly lower electrical detection and pain thresholds, suggesting altered sensory processing in these areas.

Participants with LBP also exhibited higher cold pain thresholds at lower back and shoulder sites compared to those without LBP, indicating enhanced central pain processing related to their condition.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Sensory characteristics of tender points in the lower back. Lewis, C., Souvlis, T., Sterling, M.[2010]

In a study of 102 women undergoing cesarean sections with spinal anesthesia, there were significant variations in sensory block levels assessed by different methods, with differences of up to 11 segments observed between sharp pinprick and touch assessments.

The study concluded that for clinical consistency, touch sensation levels should be reported in future research, as there was no significant difference in outcomes between the two touch assessment methods (Neurotip and ethyl chloride) when the block level was adequate.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A comparison of cold, pinprick and touch for assessing the level of spinal block at caesarean section. Russell, IF.[2008]

Facet joint pain is a significant contributor to low back pain, which is a common issue among American adults, and can be effectively diagnosed using local anesthetic blocks.

While medial branch denervation shows potential for long-term pain relief from facet joint pain, current evidence is insufficient to fully endorse it as an effective treatment option.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The provocative lumbar facet joint. Binder, DS., Nampiaparampil, DE.[2021]

Chronic low back pain often originates from facet joint issues, with studies showing that 15% to 52% of patients with chronic low back pain have lumbar facet joint involvement, highlighting the significance of these joints as pain sources.

Effective long-term treatment options for lumbar facet joint pain include intraarticular injections, medial branch blocks, and neurolysis of medial branches, which have been shown to provide therapeutic benefits.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Review of chronic low back pain of facet joint origin. Manchikanti, L., Singh, V.[2006]

The single needle technique for lumbar medial branch blocks allows for accurate diagnostic results similar to the traditional multiple needle method, while using only one entry point.

This technique may reduce patient discomfort, decrease procedure time, lower radiation exposure, and minimize the volume of local anesthetic needed, potentially leading to fewer false-positive results.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Single needle approach for multiple medial branch blocks: a new technique. Stojanovic, MP., Zhou, Y., Hord, ED., et al.[2019]

References

1. United States pubmed.ncbi.nlm.nih.gov

The gel box - a testing device for the characterization of cryo- and radiofrequency lesions employed in interventional pain therapy. [2019]

2. United States pubmed.ncbi.nlm.nih.gov

Percutaneous Image-Guided Cryoablation for the Treatment of Phantom Limb Pain in Amputees: A Pilot Study. [2022]

3. United States pubmed.ncbi.nlm.nih.gov

Cryoanalgesia in interventional pain management. [2022]

4. United States pubmed.ncbi.nlm.nih.gov

Ultrasound-guided lumbar facet nerve block: a sonoanatomic study of a new methodologic approach. [2022]

5. United States pubmed.ncbi.nlm.nih.gov

Ultrasound-guided lumbar facet nerve block: accuracy of a new technique confirmed by computed tomography. [2019]

6. United States pubmed.ncbi.nlm.nih.gov

Quantitative assessment of differential sensory blockade after lumbar epidural lidocaine. [2022]

7. United States pubmed.ncbi.nlm.nih.gov

Neurosensory sequelae assessed by thermal and vibrotactile perception thresholds after local cold injury. [2021]

8. England pubmed.ncbi.nlm.nih.gov

The effect of cryotherapy on nerve conduction velocity, pain threshold and pain tolerance. [2022]

9. Scotland pubmed.ncbi.nlm.nih.gov

Sensory characteristics of tender points in the lower back. [2010]

10. Netherlands pubmed.ncbi.nlm.nih.gov

A comparison of cold, pinprick and touch for assessing the level of spinal block at caesarean section. [2008]

11. United States pubmed.ncbi.nlm.nih.gov

The provocative lumbar facet joint. [2021]

12. United States pubmed.ncbi.nlm.nih.gov

Review of chronic low back pain of facet joint origin. [2006]

13. United States pubmed.ncbi.nlm.nih.gov

Single needle approach for multiple medial branch blocks: a new technique. [2019]