Nerve Composition of Human Lumbar Dorsal Primary Rami and Its Medial Branch

June 9, 2023 updated by: University of Aberdeen
The purpose of the study is to understand the composition of the nerves supplying the facet joints in low back.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Detailed Description

After written informed consent, the nerves supplying the facet joints - lumbar dorsal rami and its medial branches, will be harvested when they are exposed during spinal surgery. These nerves will be fixed, washed and further dissected to enable smaller sections. The cut section will be stained and subjected to analysis of overall cross-sectional area and presence of connective tissue sheaths under light microscope.

Study Type

Observational

Enrollment (Estimated)

20

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • United Kingdom
    • Scotland
      • Aberdeen, Scotland, United Kingdom, AB15 6XS
        • Recruiting
        • Woodend Hospital
        • Contact:
          • Santosh Baliga, MbChB, FRCS
        • Principal Investigator:
          • Saravana Kanakarajan, MD FRCA

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Sampling Method

Probability Sample

Study Population

The study population will be the cohort of patients who are scheduled to undergo lumbar spinal surgery. The potential population will be identified from the patients who are being invited for the surgery. All prospective participants will be sent an invitation letter and Participant Information Sheet along with their the clinical appointment letters.

Description

Inclusion Criteria:

  • Be aged 18 or over
  • be able to give informed consent
  • scheduled to undergo lumbar spinal surgery

Exclusion Criteria:

  • Children under 18 years old
  • Vulnerable adults
  • Adults with incapacity
  • Inability to provide informed consent
  • History of previous spinal surgery
  • history of previous RF ablation for low back pain
  • has COVID-19 or displaying symptoms of COVID-19

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
Active group
Patients who are scheduled to undergo lumbar spinal surgery and fulfill the inclusion and exclusion criteria
Procedure: Spinal surgery
In participants who undergo elective lumbar spinal surgery and consented for research, the medial branch and dorsal rami will be harvested for histological analysis.
Other: Histology
The harvested nerves will be fixed, cut into smaller sections. Analysis of macroscopic and light microscopic sections will be carried out

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Nerve Histology
Time Frame: one year
Percentage of nerves containing more than 50% sensory fibres in lumbar dorsal rami/medial branches to assess whether they are sensory or motor nerves
one year

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Aberdeen

Investigators

  • Principal Investigator: Saravanakumar Kanakarajan, MD FRCA, NHS Grampian

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

March 8, 2022

Primary Completion (Estimated)

January 30, 2024

Study Completion (Estimated)

December 30, 2024

Study Registration Dates

First Submitted

October 8, 2021

First Submitted That Met QC Criteria

October 22, 2021

First Posted (Actual)

October 25, 2021

Study Record Updates

Last Update Posted (Actual)

June 12, 2023

Last Update Submitted That Met QC Criteria

June 9, 2023

Last Verified

June 1, 2023

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 1-076-21

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

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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