Sensory Mapping of Lumbar Facet Joint Pain

NCT03323775 | Completed

• 1 other identifier: 2/107/17
• Study Type: observational
• Target: 15
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Chronic Pain; Facet Joint Pain

Outcome Measures

Primary Outcomes (1)

• Stimulation of the target nerves.

  Self reported estimate of percentage coverage of pain reproduction by stimulation

  Up to one hour after stimulation

Interventions

Suprathreshold stimulation DIAGNOSTIC_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.

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

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

You may not qualify if:

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

Sponsors & Collaborators

• University of Aberdeen: lead
• NHS Grampian: collaborator

Study Sites (1)

University of Aberdeen/NHS Grampian

Aberdeen, Scotland, AB25 2ZB, United Kingdom

Location

MeSH Terms

Conditions

Chronic Pain

Condition Hierarchy (Ancestors)

Pain; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 24, 2017
• First Posted: October 27, 2017
• Study Start: November 10, 2017
• Primary Completion: April 30, 2018
• Study Completion: April 30, 2018
• Last Updated: July 12, 2018

Record last verified: 2018-07

Data Sharing

• IPD Sharing: Will not share

Locations

GB (1)