Chronic PainSENS-MAPNCT03323775
Sensory Mapping of Lumbar Facet Joint Pain
An observational study of Chronic Pain and Facet Joint Pain, run by University of Aberdeen at 1 site in United Kingdom.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Chronic Pain, Facet Joint Pain
- What is being tested?
- Suprathreshold stimulation
- Type of treatment
- Injection or infusion
- How many people
- 15 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- 10 Nov 2017to 30 Apr 2018
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
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.
Who may be able to join
- -Patients scheduled for radiofrequency denervation of lumbar medial branches and L5 dorsal ramus after adequate response to diagnostic testing
Who cannot join
- Unable to understand and comprehend the information given in English
- Inability to complete pain diagram
Trial locations and contacts
1 site in 1 country.
United Kingdom1 site
University of Aberdeen/NHS Grampian
Aberdeen, Scotland, AB25 2ZB
About this study
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.
Read the 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.
- Conditions
- Chronic Pain, Facet Joint Pain
- Being tested
- Suprathreshold stimulation
- Medical subject headings
- Chronic Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Suprathreshold stimulationDiagnostic test
Intraoperatively, radiofrequency needles will be placed on specific nerves targeted using parallel needle placement technique under image guidance. These nerves will have identified by the diagnostic injections carried out previously. The nerves will be located using 50 Hz sensory stimulation. The targeted medial branches (dorsal ramus in the case of L5) will be stimulated using suprathreshold stimulation (up to three times the sensory detection threshold) to identify the pain referral area. Motor stimulation of 2 Hz will be used to identify the multifidus muscle as well as to evaluate the close proximity to major spinal nerve to improve the safety of the procedure.
What is being measured
The primary outcome is the main question the study is designed to answer.
Stimulation of the target nerves.
Self reported estimate of percentage coverage of pain reproduction by stimulation
Measured: Up to one hour after stimulation
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Oct 2017
- Study start10 Nov 2017
- Primary completion30 Apr 2018
- Study completion30 Apr 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Chronic PainStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case only
- Time perspective
- Prospective
- Enrolment
- 15 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Aberdeen
- Sponsor type
- University, hospital or other
- Collaborators
- NHS Grampian
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03323775
- Sponsor's protocol ID
- 2/107/17
- Acronym
- SENS-MAP
- Status last verified
- Jul 2018
- First submitted
- 24 Oct 2017
- Last updated
- 12 Jul 2018
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 12 Jul 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Sensory Mapping of Lumbar Facet Joint Pain
- ClinicalTrials.gov ID
- NCT03323775
- Acronym / sponsor ID
- SENS-MAP / 2/107/17
- Conditions
- Chronic Pain, Facet Joint Pain
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 15 participants (actual)
- Lead sponsor
- University of AberdeenUniversity, hospital or other
- Collaborators
- NHS Grampian
- Study start
- 10 Nov 2017 (actual)
- Primary completion
- 30 Apr 2018 (actual)
- Study completion
- 30 Apr 2018 (actual)
- First posted
- 27 Oct 2017 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Observational model
- Case only
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- 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.
Key inclusion criteria (1 listed)
- -Patients scheduled for radiofrequency denervation of lumbar medial branches and L5 dorsal ramus after adequate response to diagnostic testing
Key exclusion criteria (2 listed)
- Unable to understand and comprehend the information given in English
- Inability to complete pain diagram
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Suprathreshold stimulationIntraoperatively, radiofrequency needles will be placed on specific nerves targeted using parallel needle placement technique under image guidance. These nerves will have identified by the diagnostic injections carried out previously. The nerves will be located using 50 Hz sensory stimulation. The targeted medial branches (dorsal ramus in the case of L5) will be stimulated using suprathreshold stimulation (up to three times the sensory detection threshold) to identify the pain referral area. Motor stimulation of 2 Hz will be used to identify the multifidus muscle as well as to evaluate the close proximity to major spinal nerve to improve the safety of the procedure. | Diagnostic test | – |
Primary outcome
Stimulation of the target nerves.
Time frame: Up to one hour after stimulation
Self reported estimate of percentage coverage of pain reproduction by stimulation
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Jul 2018.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Chronic Pain and Facet Joint Pain, run by University of Aberdeen at 1 site in United Kingdom.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 12 Jul 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United Kingdom. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Stimulation of the target nerves. (time frame: Up to one hour after stimulation). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 12 Jul 2018.