Lumbar Medial Branch Blocks for Facet Joint Pain

(OMEGA Trial)

Overseen By Benedict J Alter, MD, PhD

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: University of Pittsburgh

Disqualifiers: Spine surgery, Worker's compensation, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: 2

Duration: 1 day

40 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial aims to understand how the brain and spinal cord manage pain relief following a specific back pain treatment called a lumbar medial branch block (MBB). Researchers will use computer tasks, skin probes (cutaneous probes), and sensory tests (quantitative sensory testing) to assess the effects of these treatments on back pain relief. Eligible participants have experienced daily low back pain for at least three months and have already scheduled an MBB at a UPMC Pain Management clinic. As an unphased trial, this study offers participants the chance to contribute to groundbreaking research that could improve pain management strategies.

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.

Is there any evidence suggesting that this trial's treatments are likely to be safe?

Research has shown that quantitative sensory testing (QST) is safe and easy to handle. It is noninvasive, meaning it doesn't involve surgery or needles. QST measures how the body perceives sensations like pain, touch, and temperature. No known serious side effects have been associated with QST, making it a low-risk choice for participants.

In other studies, participants underwent QST without major safety issues, suggesting the method is generally safe for humans. However, individual experiences can vary, so discussing any concerns with the research team is advisable. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about Quantitative Sensory Testing (QST) for facet joint pain because it offers a new way to understand and manage chronic low back pain. Unlike standard treatments that typically focus on relieving symptoms, like medications or physical therapy, QST aims to pinpoint how pain is processed in the nervous system by measuring sensory responses. This approach could lead to more personalized pain management strategies, potentially improving outcomes for patients who don't respond well to existing options. By gaining insights into individual pain mechanisms, researchers hope to tailor treatments more effectively, opening the door to better-targeted interventions in the future.

What evidence suggests that this trial's treatments could be effective for facet joint pain?

Research has shown that lumbar medial branch blocks (MBB) can reduce pain in the lower back caused by facet joints. In this trial, participants with chronic low back pain and a scheduled lumbar medial branch block will undergo Quantitative Sensory Testing (QST). QST helps understand how the body perceives pain and sensations like touch and temperature. By using QST, doctors can gain insights into a person's pain experience and adjust treatments like MBB for better results. This testing determines how much of a stimulus, such as pressure or heat, is needed to cause a sensation, providing insights into nerve function. While QST itself isn't a treatment, it aids doctors in understanding and improving pain management strategies. ^{2 3 4 6 7}

Who Is on the Research Team?

Benedict J Alter, MD, PhD

Principal Investigator

University of Pittsburgh

Are You a Good Fit for This Trial?

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.

Timeline for a Trial Participant

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

What Are the Treatments Tested in This Trial?

Interventions

• Computer Tasks
• Cutaneous Probe
• Quantitative Sensory Testing

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.

How Is the Trial Designed?

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+

Published Research Related to This Trial

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]

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]

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]

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]

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]

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]

A new ultrasound-guided technique for lumbar facet nerve blocks was developed and tested, showing accurate needle placement in 25 out of 28 procedures performed on patients, which suggests high clinical feasibility.

This method allows for effective pain relief in facet syndrome while avoiding the use of radiation, making it a safer alternative to traditional fluoroscopic or CT-guided approaches.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Ultrasound-guided lumbar facet nerve block: a sonoanatomic study of a new methodologic approach. Greher, M., Scharbert, G., Kamolz, LP., et al.[2022]

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]

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 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]

Citations

1.

physio-pedia.com

physio-pedia.com/Quantitative_Sensory_Testing_(QST)

Quantitative Sensory Testing (QST)

QST is a systematic psychophysical test method used to measure sensory thresholds for pain, touch, vibration, and temperature sensations.

2.

pmc.ncbi.nlm.nih.gov

pmc.ncbi.nlm.nih.gov/articles/PMC11368601/

Quantitative sensory testing: a practical guide and clinical ...

Quantitative sensory testing (QST) is a promising tool for pain phenotyping. QST represents a panel of clinical psychophysical tests that ...

3.

aetna.com

aetna.com/cpb/medical/data/300_399/0357.html

Quantitative Sensory Testing Methods

Quantitative sensory testings (QSTs) are techniques employed to measure the intensity of stimuli needed to produce specific sensory perceptions.

4.

digital-assets.wellmark.com

digital-assets.wellmark.com/adobe/assets/urn:aaid:aem:8eeef038-1c63-4825-a87e-70afc8178759/original/as/quantitative-sensory-testing.pdf

Quantitative Sensory Testing

Quantitative sensory testing (QST) systems are used for the noninvasive assessment and quantification of sensory nerve function in individuals with symptoms of, ...

5.

anthem.com

anthem.com/medpolicies/abc/active/mp_pw_a050521.html

MED.00082 Quantitative Sensory Testing

This document addresses quantitative sensory testing (QST) used for the noninvasive evaluation of sensory nerve function in individuals with symptoms.

6.

withpower.com

withpower.com/trial/phase-arthralgia-6-2023-e3b83

Lumbar Medial Branch Blocks for Facet Joint Pain

Quantitative Sensory Testing. Participants undergo quantitative sensory testing to measure CNS pain modulation before the lumbar medial branch block. 1 day. 1 ...

7.

bcbsm.com

bcbsm.com/amslibs/content/dam/public/mpr/mprsearch/pdf/106296.pdf

MEDICAL POLICY - QUANTITATIVE SENSORY TESTING

Quantitative sensory testing (QST) systems are used for the noninvasive assessment and quantification of sensory nerve function in patients with ...