Facet Joint PainNCT06157294
Pulsed Radiofrequency Treatment in Lumbar Facet-Related Pain
A study testing Intra-articular pulsed radiofrequency and Median branch pulsed radiofrequency in people with Facet Joint Pain and Pain Syndrome, run by Başakşehir Çam & Sakura City Hospital at 1 site in Turkey (Türkiye).
Trial summary
Facet joint-related pain is one of the leading causes of low back pain. Facet joint-related disorders can have a negative impact on quality of life and daily living activities, in addition to the pain.Conservative treatment methods such as analgesic medications, physical therapy, and manual therapy are used for facet… Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Facet Joint Pain, Pain Syndrome, Pain, Chronic
- What is being tested?
- Intra-articular pulsed radiofrequency and Median branch pulsed radiofrequency
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 116 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 1 Dec 2021to 27 Nov 2023
- 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 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Having facet joint-related low back pain at least 3 months
- No response to other conservative treatments (analgesic medications, physical therapy, manuel therapy etc.)
- Patients with a pain severity score of at least 6 according to NRS
Who cannot join
- History of lumbar region surgery
- Patients with bleeding disorders
- Presence of pregnancy and breastfeeding status
- Presence of the infection related findings and any other systemic disorder
- History of allergic reaction to contrast agent
- Patients who do not have sufficient mental function to fill out the scales during the follow-up periods
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site
Basahsehir Cam and Sakura City Hospital
Istanbul, 34488
About this study
Official title: Comparison of the Treatment Outcomes of the Facet Intra-articular Pulsed Radiofrequency and Median Branch Pulsed Radiofrequency Interventions in Lumbar Facet-related Pain
Facet joint-related pain is one of the leading causes of low back pain. Facet joint-related disorders can have a negative impact on quality of life and daily living activities, in addition to the pain.Conservative treatment methods such as analgesic medications, physical therapy, and manual therapy are used for facet joint-related low back pain, and interventional pain management practices are used in patients who do not respond adequately to these treatments.
Pulse radiofrequency application, which is a recent popular treatment in interventional pain management, is also frequently applied in the treatment of facet-joint related pain. Pulsed radiofrequency intervention can be applied directly intra-articularly or can be applied to the median branch, which is important structure in pain transmission. Although both methods are frequently used in pain management, there is a lack of information in the literature about which is more effective. This study aimed to compare the treatment results of intraarticular pulse radiofrequency application and median branch pulse radiofrequency application in facet joint-related low back pain.
- Conditions
- Facet Joint Pain, Pain Syndrome, Pain, Chronic
- Being tested
- Intra-articular pulsed radiofrequency, Median branch pulsed radiofrequency
- Medical subject headings
- Somatoform Disorders, Chronic Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Intra-articular pulsed radiofrequencyProcedure or surgery
Intra-articular pulsed radiofrequency procedures for the treatment of facet joint-related low back pain are performed under sterile conditions in the operating room. The application is performed under fluoroscopy guidance using a 20 gauge 10 mm active tip radiofrequency needle. When the intra-articular joint, which is the target tissue, is reached with the help of fluoroscopy images, pulse radiofrequency treatment will be applied with the parameters being maximum temperature 42 degrees, 45 volts, duration 6 minutes, pulse rate 2 hertz and pulse width 20 milliseconds.
Median branch pulsed radiofrequencyProcedure or surgery
Median branch pulsed radiofrequency procedures for the treatment of facet joint-related low back pain are performed under sterile conditions in the operating room. The application is performed under fluoroscopy guidance using a 20 gauge 10 mm active tip radiofrequency needle. When the median branch region, which is the target area, is reached with the help of fluoroscopy images, location confirmation will be provided by giving sensory and motor stimulation. Pulse radiofrequency treatment will be applied with the parameters being maximum temperature 42 degrees, 45 volts, duration 6 minutes, pulse rate 2 hertz and pulse width 20 milliseconds.
| Study group | Role | What they receive |
|---|---|---|
| Intra-articular pulsed radiofrequency group | Active comparator | This arm consists of patients who received intra-articular pulse radiofrequency treatment. Receives: Procedure: Intra-articular pulsed radiofrequency |
| Median branch pulsed radiofrequency group | Active comparator | This arm consists of patients who received median branch pulse radiofrequency treatment. Receives: Procedure: Median branch pulsed radiofrequency |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change of the pain severity score
Pain severity is assessed by using "Numeric Rating Scale" (NRS). Patients give score of their pain between 0 (no pain) and 10 (worst possible pain). The change in NRS scores between the two groups will be compared.
Measured: Pre-intervention, post-intervention 1th month and post-intervention 6th month
Secondary outcomes (1)
Change of the disability score
Disability conditions of the patients are assessed by using "Oswestry Disability Index" (ODI). ODI is a patient-completed questionnaire which gives a percentage score of disability. The ODI is comprised of 10 items and enquires about functional limitations in various activities of daily living with the index score ranging from 1 (best) to 100 (worst). The change in ODI scores between the two groups will be compared.
Measured: Pre-intervention, post-intervention 1th month and post-intervention 6th month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Dec 2023
- Study start1 Dec 2021
- Primary completion1 Jan 2023
- Study completion27 Nov 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Facet Joint 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
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 116 participants (actual)
Sponsor and investigators
- Lead sponsor
- Başakşehir Çam & Sakura City Hospital
- Sponsor type
- Other government
- Responsible party
- Sponsor
- Investigators
- Burak Erken, MD, Principal investigator, Başakşehir Çam & Sakura City Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06157294
- Sponsor's protocol ID
- 2021.05.102
- Status last verified
- Nov 2023
- First submitted
- 27 Nov 2023
- Last updated
- 5 Dec 2023
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 5 Dec 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison of the Treatment Outcomes of the Facet Intra-articular Pulsed Radiofrequency and Median Branch Pulsed Radiofrequency Interventions in Lumbar Facet-related Pain
- ClinicalTrials.gov ID
- NCT06157294
- Acronym / sponsor ID
- 2021.05.102
- Conditions
- Facet Joint Pain, Pain Syndrome, Pain, Chronic
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 116 participants (actual)
- Lead sponsor
- Başakşehir Çam & Sakura City HospitalOther government
- Study start
- 1 Dec 2021 (actual)
- Primary completion
- 1 Jan 2023 (actual)
- Study completion
- 27 Nov 2023 (actual)
- First posted
- 5 Dec 2023 (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.
Facet joint-related pain is one of the leading causes of low back pain. Facet joint-related disorders can have a negative impact on quality of life and daily living activities, in addition to the pain.Conservative treatment methods such as analgesic medications, physical therapy, and manual therapy are used for facet joint-related low back pain, and interventional pain management practices are used in patients who do not respond adequately to these treatments.
Pulse radiofrequency application, which is a recent popular treatment in interventional pain management, is also frequently applied in the treatment of facet-joint related pain. Pulsed radiofrequency intervention can be applied directly intra-articularly or can be applied to the median branch, which is important structure in pain transmission. Although both methods are frequently used in pain management, there is a lack of information in the literature about which is more effective. This study aimed to compare the treatment results of intraarticular pulse radiofrequency application and median branch pulse radiofrequency application in facet joint-related low back pain.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Intra-articular pulsed radiofrequency group | Active comparator | Procedure: Intra-articular pulsed radiofrequencyThis arm consists of patients who received intra-articular pulse radiofrequency treatment. |
| Median branch pulsed radiofrequency group | Active comparator | Procedure: Median branch pulsed radiofrequencyThis arm consists of patients who received median branch pulse radiofrequency treatment. |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Having facet joint-related low back pain at least 3 months
- No response to other conservative treatments (analgesic medications, physical therapy, manuel therapy etc.)
- Patients with a pain severity score of at least 6 according to NRS
Key exclusion criteria (6 listed)
- History of lumbar region surgery
- Patients with bleeding disorders
- Presence of pregnancy and breastfeeding status
- Presence of the infection related findings and any other systemic disorder
- History of allergic reaction to contrast agent
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 pulsed radiofrequencyIntra-articular pulsed radiofrequency procedures for the treatment of facet joint-related low back pain are performed under sterile conditions in the operating room. The application is performed under fluoroscopy guidance using a 20 gauge 10 mm active tip radiofrequency needle. When the intra-articular joint, which is the target tissue, is reached with the help of fluoroscopy images, pulse radiofrequency treatment will be applied with the parameters being maximum temperature 42 degrees, 45 volts, duration 6 minutes, pulse rate 2 hertz and pulse width 20 milliseconds. | Procedure or surgery | Intra-articular pulsed radiofrequency group |
| Median branch pulsed radiofrequencyMedian branch pulsed radiofrequency procedures for the treatment of facet joint-related low back pain are performed under sterile conditions in the operating room. The application is performed under fluoroscopy guidance using a 20 gauge 10 mm active tip radiofrequency needle. When the median branch region, which is the target area, is reached with the help of fluoroscopy images, location confirmation will be provided by giving sensory and motor stimulation. Pulse radiofrequency treatment will be applied with the parameters being maximum temperature 42 degrees, 45 volts, duration 6 minutes, pulse rate 2 hertz and pulse width 20 milliseconds. | Procedure or surgery | Median branch pulsed radiofrequency group |
Primary outcome
Change of the pain severity score
Time frame: Pre-intervention, post-intervention 1th month and post-intervention 6th month
Pain severity is assessed by using "Numeric Rating Scale" (NRS). Patients give score of their pain between 0 (no pain) and 10 (worst possible pain). The change in NRS scores between the two groups will be compared.
1 secondary outcome
Change of the disability score
Time frame: Pre-intervention, post-intervention 1th month and post-intervention 6th month
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 5 Dec 2023.
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Association of Subcutaneous Fat Index, Paraspinal Muscle Characteristics, and Facet Morphology With Lumbar Facet Joint Degeneration
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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.
Burak Erken, MD principal investigator
Başakşehir Çam & Sakura City Hospital
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 pulsed radiofrequency and Median branch pulsed radiofrequency in people with Facet Joint Pain and Pain Syndrome, run by Başakşehir Çam & Sakura City Hospital 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 3 inclusion and 6 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 5 Dec 2023. 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?
Change of the pain severity score (time frame: Pre-intervention, post-intervention 1th month and post-intervention 6th month). 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 5 Dec 2023.