Chronic Pain Clinical Trial
Official title:
Sensory Mapping of Lumbar Facet Joint Pain
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.
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.
;
Status | Clinical Trial | Phase | |
---|---|---|---|
Completed |
NCT01659073 -
Using Perfusion MRI to Measure the Dynamic Changes in Neural Activation Associated With Caloric Vestibular Stimulation
|
N/A | |
Recruiting |
NCT05914311 -
Use of Dermabond in Mitigation of Spinal Cord Stimulation (SCS) Trial Lead Migration
|
N/A | |
Recruiting |
NCT05422456 -
The Turkish Version of Functional Disability Inventory
|
||
Enrolling by invitation |
NCT05422443 -
The Turkish Version of Pain Coping Questionnaire
|
||
Completed |
NCT05057988 -
Virtual Empowered Relief for Chronic Pain
|
N/A | |
Completed |
NCT04385030 -
Neurostimulation and Mirror Therapy in Traumatic Brachial Plexus Injury
|
N/A | |
Recruiting |
NCT06206252 -
Can Medical Cannabis Affect Opioid Use?
|
||
Completed |
NCT05103319 -
Simultaneous Application of Ketamine and Lidocaine During an Ambulatory Infusion Therapy as a Treatment Option in Refractory Chronic Pain Conditions
|
||
Completed |
NCT03687762 -
Back on Track to Healthy Living Study
|
N/A | |
Completed |
NCT04171336 -
Animal-assisted Therapy for Children and Adolescents With Chronic Pain
|
N/A | |
Completed |
NCT03179475 -
Targin® for Chronic Pain Management in Patients With Spinal Cord Injury
|
Phase 4 | |
Completed |
NCT03418129 -
Neuromodulatory Treatments for Pain Management in TBI
|
N/A | |
Completed |
NCT03268551 -
MEMO-Medical Marijuana and Opioids Study
|
||
Recruiting |
NCT06204627 -
TDCS* and Laterality Trainnning in Patients With Chronic Neck Pain
|
N/A | |
Recruiting |
NCT06060028 -
The Power of Touch. Non-Invasive C-Tactile Stimulation for Chronic Osteoarthritis Pain
|
N/A | |
Completed |
NCT05496205 -
A SAD Study to Evaluate the Safety, Tolerability and PK/PD of iN1011-N17 in Healthy Volunteers
|
Phase 1 | |
Completed |
NCT00983385 -
Evaluation of Effectiveness and Tolerability of Tapentadol Hydrochloride in Subjects With Severe Chronic Low Back Pain Taking Either WHO Step I or Step II Analgesics or no Regular Analgesics
|
Phase 3 | |
Recruiting |
NCT05118204 -
Randomized Trial of Buprenorphine Microdose Inductions During Hospitalization
|
Phase 4 | |
Terminated |
NCT03538444 -
Repetitive Transcranial Magnetic Stimulation for Opiate Use Disorder
|
N/A | |
Not yet recruiting |
NCT05812703 -
Biometrics and Self-reported Health Changes in Adults Receiving Behavioral Treatments for Chronic Pain
|