Lumbar Facet ArthrosisNCT05091112
Nerve Composition of Human Lumbar Dorsal Primary Rami and Its Medial Branch
An observational study of Lumbar Facet Arthrosis and Nerve Degeneration, run by University of Aberdeen at 1 site in United Kingdom.
Trial summary
The purpose of the study is to understand the composition of the nerves supplying the facet joints in low back. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Lumbar Facet Arthrosis, Nerve Degeneration
- What is being tested?
- Spinal surgery and Histology
- Type of treatment
- Surgery or procedure
- How many people
- 20 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- 8 Mar 2022to 31 Dec 2024
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
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.
Who may be able to join
- Be aged 18 or over
- be able to give informed consent
- scheduled to undergo lumbar spinal surgery
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United Kingdom1 site, 1 recruiting
- Recruiting
Woodend Hospital
Aberdeen, Scotland, AB15 6XS
Santosh Baliga, MbChB, FRCS
Saravana Kanakarajan, MD FRCA
About this study
The purpose of the study is to understand the composition of the nerves supplying the facet joints in low back.
Read the 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.
- Conditions
- Lumbar Facet Arthrosis, Nerve Degeneration
- Being tested
- Spinal surgery, Histology
- Medical subject headings
- Nerve Degeneration
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Spinal surgeryProcedure or 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.
HistologyOther
The harvested nerves will be fixed, cut into smaller sections. Analysis of macroscopic and light microscopic sections will be carried out
| Study group | Role | What they receive |
|---|---|---|
| Active group | Patients who are scheduled to undergo lumbar spinal surgery and fulfill the inclusion and exclusion criteria Receives: Procedure: Spinal surgery; Other: Histology |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: one year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Oct 2021
- Study start8 Mar 2022
- Primary completion31 Dec 2024 (estimated)
- Study completion31 Dec 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Lumbar Facet ArthrosisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Cross-sectional
- Enrolment
- 20 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Aberdeen
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Saravanakumar Kanakarajan, MD FRCA, Principal investigator, NHS Grampian
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05091112
- Sponsor's protocol ID
- 1-076-21
- Status last verified
- Dec 2024
- First submitted
- 8 Oct 2021
- Last updated
- 24 Dec 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 24 Dec 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Nerve Composition of Human Lumbar Dorsal Primary Rami and Its Medial Branch
- ClinicalTrials.gov ID
- NCT05091112
- Acronym / sponsor ID
- 1-076-21
- Conditions
- Lumbar Facet Arthrosis, Nerve Degeneration
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 20 participants (estimated)
- Lead sponsor
- University of AberdeenUniversity, hospital or other
- Study start
- 8 Mar 2022 (actual)
- Primary completion
- 31 Dec 2024 (estimated)
- Study completion
- 31 Dec 2024 (estimated)
- First posted
- 25 Oct 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The purpose of the study is to understand the composition of the nerves supplying the facet joints in low back.
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 design
- Observational model
- Cohort
- Time perspective
- Cross-sectional
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Active group | – | Procedure: Spinal surgery, Other: HistologyPatients who are scheduled to undergo lumbar spinal surgery and fulfill the inclusion and exclusion criteria |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- 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.
Key inclusion criteria (3 listed)
- Be aged 18 or over
- be able to give informed consent
- scheduled to undergo lumbar spinal surgery
Key exclusion criteria (7 listed)
- Children under 18 years old
- Vulnerable adults
- Adults with incapacity
- Inability to provide informed consent
- History of previous spinal surgery
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Spinal surgeryIn participants who undergo elective lumbar spinal surgery and consented for research, the medial branch and dorsal rami will be harvested for histological analysis. | Procedure or surgery | Active group |
| HistologyThe harvested nerves will be fixed, cut into smaller sections. Analysis of macroscopic and light microscopic sections will be carried out | Other | Active group |
Primary outcome
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
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Dec 2024.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Saravanakumar Kanakarajan, MD FRCA principal investigator
NHS Grampian
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Lumbar Facet Arthrosis and Nerve Degeneration, run by University of Aberdeen at 1 site in United Kingdom.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 24 Dec 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United Kingdom. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Saravanakumar Kanakarajan, MD FRCA (00 44 1224 553237, saravanakumark@abdn.ac.uk), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Nerve Histology (time frame: one year). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 24 Dec 2024.