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

Nerve Degeneration Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05091112
• Other study ID #: 1-076-21
• Status: Recruiting
• Start date: March 8, 2022
• Est. completion date: December 30, 2024

Study information

• Verified date: June 2023
• Source: University of Aberdeen
• Contact: Saravanakumar Kanakarajan, MD FRCA
• Phone: 00 44 1224 553237
• Email: saravanakumark[@]abdn.ac.uk
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 20
• Est. completion date: December 30, 2024
• Est. primary completion date: January 30, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Nerve Degeneration
• Osteoarthritis

Intervention

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

Locations

Country	Name	City	State
United Kingdom	Woodend Hospital	Aberdeen	Scotland

Sponsors (1)

Lead Sponsor	Collaborator
University of Aberdeen

Country where clinical trial is conducted

United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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