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

NCT05091112 | Recruiting

• 1 other identifier: 1-076-21
• Study Type: observational
• Target: 20
• Locations: 1 country
• Sites: 1

Brief Summary

The purpose of the study is to understand the composition of the nerves supplying the facet joints in low back.

Conditions

Lumbar Facet Arthrosis; Nerve Degeneration

Outcome Measures

Primary Outcomes (1)

• Nerve Histology

  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

Study Arms (1)

Active group

Patients who are scheduled to undergo lumbar spinal surgery and fulfill the inclusion and exclusion criteria

Procedure: Spinal surgery; Other: Histology

Interventions

Spinal surgery PROCEDURE

In participants who undergo elective lumbar spinal surgery and consented for research, the medial branch and dorsal rami will be harvested for histological analysis.

Active group

Histology OTHER

The harvested nerves will be fixed, cut into smaller sections. Analysis of macroscopic and light microscopic sections will be carried out

Active group

Eligibility Criteria

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

You may qualify if:

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

You may not qualify if:

• 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

Sponsors & Collaborators

• University of Aberdeen: lead

Study Sites (1)

Woodend Hospital

Aberdeen, Scotland, AB15 6XS, United Kingdom

RECRUITING

Biospecimen

Retention: SAMPLES WITHOUT DNA

The excess tissue harvested from the participants will be stored in the biorepository

MeSH Terms

Conditions

Nerve Degeneration

Interventions

Shadowing Technique, Histology

Condition Hierarchy (Ancestors)

Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Staining and Labeling; Histocytological Preparation Techniques; Cytological Techniques; Clinical Laboratory Techniques; Diagnostic Techniques and Procedures; Diagnosis; Histological Techniques; Investigative Techniques

Study Officials

• Saravanakumar Kanakarajan, MD FRCA

  NHS Grampian

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Saravanakumar Kanakarajan, MD FRCA

CONTACT

00 44 1224 553237; saravanakumark@abdn.ac.uk

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: CROSS SECTIONAL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 8, 2021
• First Posted: October 25, 2021
• Study Start: March 8, 2022
• Primary Completion: December 31, 2024
• Study Completion: December 31, 2024
• Last Updated: December 24, 2024

Record last verified: 2024-12

Data Sharing

• IPD Sharing: Will not share

Locations

GB (1)