CompletedNot Applicable

Sensory Mapping of Lumbar Facet Joint Pain

United Kingdom15 participantsStarted 2017-11-10

Plain-language 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. 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.

Who can participate

Age range

18 Years – 80 Years

Sex

ALL

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Inclusion criteria

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

Questions worth asking your doctor

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1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

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Questions for the trial coordinator

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1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

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What they're measuring

Stimulation of the target nerves.

Timeframe: Up to one hour after stimulation

Trial details

NCT IDNCT03323775

SponsorUniversity of Aberdeen

Sponsor typeOTHER

Study typeOBSERVATIONAL

Primary completion2018-04-30

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