Low Back Pain, MechanicalNCT06325631
Comparative Evaluation of the Results of Facet Joint Injections
A study testing Intra-articular injection to lumbar facet joint in people with Low Back Pain, Mechanical and Facet Syndrome of Lumbar Spine, run by Oznur Uzun at 1 site in Turkey (Türkiye).
Trial summary
Low back pain affects 60 to 90% of the total population. It is one of the most common causes of disability in adults. Low back pain can be originated from a wide variety of structures, and the facet joint is one of these structures. It is thought that 21 to 41% of low back pain originates from the facet joint. Read more about this study
- Who is it for?
- Ages 18 to 60 years
- Conditions the study is for
- Low Back Pain, Mechanical, Facet Syndrome of Lumbar Spine
- What is being tested?
- Intra-articular injection to lumbar facet joint
- Type of treatment
- Injection or infusion, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 2 Jan 2023to 30 Apr 2024
- 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 18 to 60 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- Patients with facet joint syndrome diagnosis
Who cannot join
- pregnant patients
- breastfeeding patients
- patients with cardiac pacemaker
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Comparative Evaluation of the Results of Facet Joint Injections Performed by Using Fluoroscopy, Ultrasound Guidance and Anatomic Location Administered to the Patients With Facet Syndrome
Low back pain affects 60 to 90% of the total population. It is one of the most common causes of disability in adults. Low back pain can be originated from a wide variety of structures, and the facet joint is one of these structures. It is thought that 21 to 41% of low back pain originates from the facet joint. A wide variety of conservative treatments, including intra-articular injections, are used to treat low back pain originating from the facet joint. However, there is still no consensus on the most effective treatment method. With appropriate patient selection, facet joint injections can provide significant improvements in patients' pain scores. After Goldthwait defined the facet joint concept in 1911, Ghormley defined facet joint syndrome in 1933. The source of pain in 40-50% of patients is the lumbar facet joints. Innervation of the lumbar facet joints is provided by the medial branches of the dorsal roots of the spinal nerves. In 1975, Shealy described the coagulation of the articular nerve support of the spinal facet joints with the radiofrequency method. These methods have been further developed over time. The results of facet joint injections are satisfactory in well-selected patient groups. It has been shown that intra-articular steroid injection to the facet joint is superior to systemic steroid use in patients with low back pain. In this study, it was aimed to methodically compare the facet joint injections applied to patients diagnosed with facet syndrome in the outpatient clinic of the Physical Therapy and Rehabilitation Hospital in terms of patient pain scores, application time, effort spent and patient anxiety. Intra-articular injections will be performed under by fluoroscopy or ultrasound guidance or anatomic location.
- Being tested
- Intra-articular injection to lumbar facet joint
- Keywords
- facet joint syndrome, low back pain, fluoroscopy, ultrasound
- Medical subject headings
- Low Back Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Intra-articular injection to lumbar facet jointProcedure or surgery
to treat low back pain caused by facet joint syndrome
| Study group | Role | What they receive |
|---|---|---|
| Fluoroscopy | Experimental | Not described Receives: Procedure: Intra-articular injection to lumbar facet joint |
| Ultrasound | Experimental | Not described Receives: Procedure: Intra-articular injection to lumbar facet joint |
| Anatomic | Experimental | Not described Receives: Procedure: Intra-articular injection to lumbar facet joint |
What is being measured
The primary outcome is the main question the study is designed to answer.
Visual Analogue Scale
Pain intensity will be measured with Visual Analogue Scale, which is used to measure musculoskeletal pain with very good reliability and validity. Visual Analogue Scale is between 0-10 cm. 0 means no pain, 10 means the most severe pain.
Measured: VAS will be applied to the patients before the procedure and at the first and twelfth week after the procedure
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Mar 2024
- Study start2 Jan 2023
- Primary completion31 Mar 2024
- Study completion30 Apr 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (4)Papers the sponsor has linked to this study.
- Other trials for Low Back Pain, MechanicalStudies 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
- Crossover
- Masking
- Single blind
- Who is masked
- Investigator
- Enrolment
- 30 participants (actual)
Sponsor and investigators
- Lead sponsor
- Oznur Uzun
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Oznur Uzun, Ankara City Hospital Bilkent
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06325631
- Sponsor's protocol ID
- Ankara City Hospital Bilkent
- Status last verified
- Aug 2024
- First submitted
- 10 Mar 2024
- Last updated
- 21 Aug 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Gomez Vega JC, Acevedo-Gonzalez JC. Clinical diagnosis scale for pain lumbar of facet origin: systematic review of literature and pilot study. Neurocirugia (Engl Ed). 2019 May-Jun;30(3):133-143. doi: 10.1016/j.neucir.2018.05.004. Epub 2018 Jun 14. English, Spanish.
PubMed 29910103Manchikanti L, Singh V, Falco FJ, Cash KA, Pampati V. Evaluation of lumbar facet joint nerve blocks in managing chronic low back pain: a randomized, double-blind, controlled trial with a 2-year follow-up. Int J Med Sci. 2010 May 28;7(3):124-35. doi: 10.7150/ijms.7.124.
PubMed 20567613Nelson AM, Nagpal G. Interventional Approaches to Low Back Pain. Clin Spine Surg. 2018 Jun;31(5):188-196. doi: 10.1097/BSD.0000000000000542.
PubMed 28486278Baroncini A, Maffulli N, Eschweiler J, Knobe M, Tingart M, Migliorini F. Management of facet joints osteoarthritis associated with chronic low back pain: A systematic review. Surgeon. 2021 Dec;19(6):e512-e518. doi: 10.1016/j.surge.2020.12.004. Epub 2021 Feb 10.
PubMed 33582054
Study at a glance
From the registry record, last updated by the sponsor on 21 Aug 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparative Evaluation of the Results of Facet Joint Injections Performed by Using Fluoroscopy, Ultrasound Guidance and Anatomic Location Administered to the Patients With Facet Syndrome
- ClinicalTrials.gov ID
- NCT06325631
- Acronym / sponsor ID
- Ankara City Hospital Bilkent
- Keywords
- facet joint syndrome, low back pain, fluoroscopy, ultrasound
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 30 participants (actual)
- Lead sponsor
- Oznur UzunUniversity, hospital or other
- Study start
- 2 Jan 2023 (actual)
- Primary completion
- 31 Mar 2024 (actual)
- Study completion
- 30 Apr 2024 (actual)
- First posted
- 22 Mar 2024 (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.
Low back pain affects 60 to 90% of the total population. It is one of the most common causes of disability in adults. Low back pain can be originated from a wide variety of structures, and the facet joint is one of these structures. It is thought that 21 to 41% of low back pain originates from the facet joint. A wide variety of conservative treatments, including intra-articular injections, are used to treat low back pain originating from the facet joint. However, there is still no consensus on the most effective treatment method. With appropriate patient selection, facet joint injections can provide significant improvements in patients' pain scores. After Goldthwait defined the facet joint concept in 1911, Ghormley defined facet joint syndrome in 1933. The source of pain in 40-50% of patients is the lumbar facet joints. Innervation of the lumbar facet joints is provided by the medial branches of the dorsal roots of the spinal nerves. In 1975, Shealy described the coagulation of the articular nerve support of the spinal facet joints with the radiofrequency method. These methods have been further developed over time. The results of facet joint injections are satisfactory in well-selected patient groups. It has been shown that intra-articular steroid injection to the facet joint is superior to systemic steroid use in patients with low back pain. In this study, it was aimed to methodically compare the facet joint injections applied to patients diagnosed with facet syndrome in the outpatient clinic of the Physical Therapy and Rehabilitation Hospital in terms of patient pain scores, application time, effort spent and patient anxiety. Intra-articular injections will be performed under by fluoroscopy or ultrasound guidance or anatomic location.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Single blind (investigator)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Fluoroscopy | Experimental | Procedure: Intra-articular injection to lumbar facet joint |
| Ultrasound | Experimental | Procedure: Intra-articular injection to lumbar facet joint |
| Anatomic | Experimental | Procedure: Intra-articular injection to lumbar facet joint |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (1 listed)
- Patients with facet joint syndrome diagnosis
Key exclusion criteria (3 listed)
- pregnant patients
- breastfeeding patients
- patients with cardiac pacemaker
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 |
|---|---|---|
| Intra-articular injection to lumbar facet jointto treat low back pain caused by facet joint syndrome | Procedure or surgery | Anatomic, Fluoroscopy, Ultrasound |
Primary outcome
Visual Analogue Scale
Time frame: VAS will be applied to the patients before the procedure and at the first and twelfth week after the procedure
Pain intensity will be measured with Visual Analogue Scale, which is used to measure musculoskeletal pain with very good reliability and validity. Visual Analogue Scale is between 0-10 cm. 0 means no pain, 10 means the most severe pain.
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 21 Aug 2024.
- Results publication: PubMed 29910103Gomez Vega JC, Acevedo-Gonzalez JC. Clinical diagnosis scale for pain lumbar of facet origin: systematic review of literature and pilot study. Neurocirugia (Engl Ed). 2019 May-Jun;30(3):133-143. doi: 10.1016/j.neucir.2018.05.004. Epub 2018 Jun 14. English, Spanish.
- Results publication: PubMed 20567613Manchikanti L, Singh V, Falco FJ, Cash KA, Pampati V. Evaluation of lumbar facet joint nerve blocks in managing chronic low back pain: a randomized, double-blind, controlled trial with a 2-year follow-up. Int J Med Sci. 2010 May 28;7(3):124-35. doi: 10.7150/ijms.7.124.
- Results publication: PubMed 28486278Nelson AM, Nagpal G. Interventional Approaches to Low Back Pain. Clin Spine Surg. 2018 Jun;31(5):188-196. doi: 10.1097/BSD.0000000000000542.
- Results publication: PubMed 33582054Baroncini A, Maffulli N, Eschweiler J, Knobe M, Tingart M, Migliorini F. Management of facet joints osteoarthritis associated with chronic low back pain: A systematic review. Surgeon. 2021 Dec;19(6):e512-e518. doi: 10.1016/j.surge.2020.12.004. Epub 2021 Feb 10.
- 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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Intra-articular injection to lumbar facet joint in people with Low Back Pain, Mechanical and Facet Syndrome of Lumbar Spine, run by Oznur Uzun at 1 site in Turkey (Türkiye).
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 1 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 21 Aug 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 Turkey (Türkiye). 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?
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?
Visual Analogue Scale (time frame: VAS will be applied to the patients before the procedure and at the first and twelfth week after the procedure). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06325631, which also lists 4 linked publications.
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 21 Aug 2024.