Sensory Mapping of Lumbar Facet Joint Pain (SENS-MAP)

Low back pain is a major contributor to the chronic pain burden in the community. Although there are numerous pain generators in the spine, lumbar facet joints are one of the most common sources of pain. A variety of measures such as physiotherapy, oral analgesics and minimally invasive injections are used to treat lumbar facet joint pain.

Facet joint steroid injections and radiofrequency denervations of the facet joint are the most commonly performed minimally invasive pain procedures for lumbar facet joint pain. Radiofrequency denervation is carried out by thermal lesioning of the medial branches that supply the facet joints. Conventionally two medial branches have been shown to innervate one facet joint and based on this, the norm is to lesion two nerves to denervate one facet joint. However, there is some variation in the nerve supply which may account for failure or false negative results of the diagnostic blocks.

The aim of the present study is to explore the feasibility of sensory mapping, thereby referral pattern of the lumbar medial branches using suprathreshold stimulation and to correlate the referral patterns with painful areas in the back and leg. It will also test if the present method of lesioning two nerves to denervate one facet joint is appropriate.

Study Overview

• Status: Completed
• Conditions: Chronic Pain; Facet Joint Pain
• Intervention / Treatment: Diagnostic test: Suprathreshold stimulation

Detailed Description

Chronic pain is defined as pain lasting more than three months duration. Between one third and one half of the population of the UK are affected by chronic pain. This corresponds to just less than 28 million adults. Chronic low back pain is an important contributor to the chronic pain burden. Up to a third of UK's population is affected by low back ache each year and 20% visit their general practitioner for advice. The result is that nearly 2.6 million people are seeking medical care for back pain in a year. This translates into a huge economic burden on the already stretched healthcare budgets. The health care cost of low back ache was estimated to be £1632 million in 1998.4 However the indirect cost of low back pain mainly due to lost productivity is much higher and conservative estimates put it at £3440 million in 1998. It would not be hard to imagine what the present economic burden of chronic low back pain would be if inflation is factored in to the above figures. Apart from the fact that chronic low back pain has a huge economic impact, it does cause significant loss of function from an individual's perspective, damaged relationships and difficulties at workplace.

Lumbar facet joint pain

Mechanical low back pain is the most common cause of chronic low back pain. Anatomical structures, such as facet joints, sacro-iliac joints, posterior longitudinal ligaments and muscles have been found to generate and contribute to the mechanical low back pain. The lumbar zygapophyseal (facet) joints are the pain generators in 15% to 45% of patients with chronic low back pain. Variety of interventional treatment modalities have been used to treat facet joint pain. Intraarticular injections of steroids and radiofrequency (RF) ablation of the nerve supply of the facet joints are the most widely practised. A recent NICE guideline (NG 59) has recommended radiofrequency denervation but not steroid injections for proven lumbar facet joint pain.

The lumbar facet joints are innervated by the medial branches of posterior primary ramus of the spinal nerve (L1-L5). Each of these posterior primary rami divide into medial, intermediate and lateral branches (except L5 posterior primary ramus). The medial branches innervate the facet joints and the multifidus muscle. The intermediate branches innervate the muscle longissimus thoracis. The lateral branches innervate the iliocostalis lumborum muscle. The lateral branches of L1, 2 ,3 supply the skin over the lower back.

The nerve supply - medial branch and dorsal ramus have been the target for RF interventions to relieve facet joint pain. Anatomical studies in 1980s found that facet joint has a dual innervation - for instance, the L4-5 facet joint derives its innervation from the medial branches of dorsal rami of L3 and L4. The medial branches of L1-4 and the posterior primary ramus of L5 have a relatively fixed anatomical course, thereby rendering themselves good targets for interventions. This forms the basis of targeting two nerves to denervate one facet joint. The success rate of RF denervation varies from 50 to 90% .9, 10 The varied success rate is often attributed to single diagnostic blocks and procedural variations. But anatomical variation is not often considered. A recent study has showed that there is significant variation in the individual nerve supply to facet joints which may add to the false -negatives of diagnostic blocks and inadequate pain relief from radiofrequency denervation. One way of improving the success rate is to reproduce the pain by electrical stimulation prior to RF treatment.

Lumbar medial branches and fifth lumbar dorsal ramus have been electrically stimulated not only in healthy volunteers but also in pain patients. A recent study has shown that supratheshold stimulation of facet joints in healthy volunteers results in local and referred pain.However none of the studies have correlated the suprathreshold stimulation to map the painful area. Hence we propose to map the painful area by suprathreshold stimulation.

Rationale for Study Based on conventional anatomical studies, two medial branches are denervated to treat pain from one facet joint. But this does not take into account of the anatomical variation of individuals, thereby potentially over or under treating the pain. In this study the investigators will map the painful areas by stimulating the medial branches, thus estimating how necessary it is to lesion the medial branches according to the standard practice.

• Study Type: Observational
• Enrollment (Actual): 15

Contacts and Locations

Study Locations

• United Kingdom
  • Scotland
    • Aberdeen, Scotland, United Kingdom, AB25 2ZB
      • University of Aberdeen/NHS Grampian

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 16 years to 78 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

Potential participants will be identified from the patients scheduled to undergo lumbar medial branch RF denervation at the surgical short stay unit, Aberdeen Royal Infirmary.

Description

Inclusion Criteria:

-Patients scheduled for radiofrequency denervation of lumbar medial branches and L5 dorsal ramus after adequate response to diagnostic testing

Exclusion Criteria:

• Unable to understand and comprehend the information given in English
• Inability to complete pain diagram

Study Plan

How is the study designed?

Design Details

• Observational Models: Case-Only
• Time Perspectives: Prospective

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Stimulation of the target nerves.	Self reported estimate of percentage coverage of pain reproduction by stimulation	Up to one hour after stimulation

Collaborators and Investigators

• Sponsor: University of Aberdeen
• Collaborators: NHS Grampian

Study record dates

Study Major Dates

• Study Start (Actual): November 10, 2017
• Primary Completion (Actual): April 30, 2018
• Study Completion (Actual): April 30, 2018

Study Registration Dates

• First Submitted: October 24, 2017
• First Submitted That Met QC Criteria: October 24, 2017
• First Posted (Actual): October 27, 2017

Study Record Updates

• Last Update Posted (Actual): July 12, 2018
• Last Update Submitted That Met QC Criteria: July 10, 2018
• Last Verified: July 1, 2018

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pain; Neurologic Manifestations; Joint Diseases; Musculoskeletal Diseases; Arthralgia; Chronic Pain
• Other Study ID Numbers: 2/107/17

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No