Back PainNCT03487120
Open Facet Joint Denervation in the Treatment of Low Back Pain
A study testing facet joint denervation in people with Back Pain, run by Queen's University.
Trial summary
A single blinded RCT for adult patients with spine pain. One group had a lumbar laminectomy with denervation of the facet joint at the level decompressed. The other group had a lumbar laminectomy without facet joint denervation. Read more about this study
- Who is it for?
- Ages 19 years and older
- Conditions the study is for
- Back Pain
- What is being tested?
- facet joint denervation
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- No sites listed yet
- Study dates
- 26 Apr 2016to 11 Apr 2017
- Phase
- Interventional
- Are there results?
- None posted in the registry
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 19 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- aged 19 or older
- a diagnosis of spinal stenosis
- having neurogenic claudication
- complained of back pain for at least 3 months
Who cannot join
- previous surgery on their spine,
- fracture, systemic inflammatory disease,
- malignancies or an infection affecting their spine
About this study
Official title: Open Facet Joint Denervation in the Treatment of Low Back Pain -A Randomized Control Trial.
A single blinded RCT for adult patients with spine pain. One group had a lumbar laminectomy with denervation of the facet joint at the level decompressed. The other group had a lumbar laminectomy without facet joint denervation. Both groups had their back pain and functional limitations measured using a 10 cm visual analogue scale and the Oswestry disability index (ODI). All measures were taken before surgery and at patients' 6, 12 and 24 week follow-up clinic visit.
- Conditions
- Back Pain
- Being tested
- facet joint denervation
- Medical subject headings
- Back Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
facet joint denervationProcedure or surgery
Bipolar electrocautery
| Study group | Role | What they receive |
|---|---|---|
| lumbar laminectomy | No intervention | Not described |
| lumbar laminectomy with denervation of the facet joint | Active comparator | Not described Receives: Procedure: facet joint denervation |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in Visual analog scale for pain (VAS)
10 centimeter scale with a minimum of 0 indicating no pain and a maximum of 10 indicating worst pain.
Measured: change from baseline score at 24 weeks
Secondary outcomes (1)
Change in Modified Oswestry Disability score (ODI)
The ODI is divided into ten sections designed to assess limitations of various activities of daily living. Each section is scored on a 0-5 scale. The range of scores is 0 to a maximum of 60. The total score is multiplied by 2 and expressed as a percentage. A score of 0 to 20 points indicates minimal disability; 20 to 40 points, moderate disability; and 40 to 60 points, severe disability.
Measured: change from baseline score at 24 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Apr 2018
- Study start26 Apr 2016
- Primary completion10 Apr 2017
- Study completion11 Apr 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Back PainStudies 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 60 participants (actual)
Sponsor and investigators
- Lead sponsor
- Queen's University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Dr. David Yen, Queen's University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03487120
- Sponsor's protocol ID
- NCTO
- Status last verified
- Apr 2023
- First submitted
- 23 Mar 2018
- Last updated
- 10 Apr 2023
- 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 10 Apr 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Open Facet Joint Denervation in the Treatment of Low Back Pain -A Randomized Control Trial.
- ClinicalTrials.gov ID
- NCT03487120
- Acronym / sponsor ID
- NCTO
- Conditions
- Back Pain
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 60 participants (actual)
- Lead sponsor
- Queen's UniversityUniversity, hospital or other
- Study start
- 26 Apr 2016 (actual)
- Primary completion
- 10 Apr 2017 (actual)
- Study completion
- 11 Apr 2017 (actual)
- First posted
- 3 Apr 2018 (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.
A single blinded RCT for adult patients with spine pain. One group had a lumbar laminectomy with denervation of the facet joint at the level decompressed. The other group had a lumbar laminectomy without facet joint denervation. Both groups had their back pain and functional limitations measured using a 10 cm visual analogue scale and the Oswestry disability index (ODI). All measures were taken before surgery and at patients' 6, 12 and 24 week follow-up clinic visit.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| lumbar laminectomy | No intervention | – |
| lumbar laminectomy with denervation of the facet joint | Active comparator | Procedure: facet joint denervation |
Who may qualify
- Ages
- 19 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- aged 19 or older
- a diagnosis of spinal stenosis
- having neurogenic claudication
- complained of back pain for at least 3 months
Key exclusion criteria (3 listed)
- previous surgery on their spine,
- fracture, systemic inflammatory disease,
- malignancies or an infection affecting their spine
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 |
|---|---|---|
| facet joint denervationBipolar electrocautery | Procedure or surgery | lumbar laminectomy with denervation of the facet joint |
Primary outcome
Change in Visual analog scale for pain (VAS)
Time frame: change from baseline score at 24 weeks
10 centimeter scale with a minimum of 0 indicating no pain and a maximum of 10 indicating worst pain.
1 secondary outcome
Change in Modified Oswestry Disability score (ODI)
Time frame: change from baseline score at 24 weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Apr 2023.
- 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. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
A study testing facet joint denervation in people with Back Pain, run by Queen's University.
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 4 inclusion and 3 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: finished, as of the sponsor's last update on 10 Apr 2023. Status can change between updates, so confirm with the study contact before making plans.
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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in Visual analog scale for pain (VAS) (time frame: change from baseline score at 24 weeks). 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 10 Apr 2023.