Pain, ChronicNCT05247892
Effectiveness of Ultrasound Versus Fluoroscopy Guided S1 Injections and Radiofrequency
A study testing Ultrasound-guided S1 Radiofrequency stimulation and Fluoroscopic-guided S1 Radiofrequency stimulation in people with Pain, Chronic, run by Diskapi Teaching and Research Hospital at 1 site in Turkey (Türkiye).
Trial summary
The investigators aim to compare the effect of ultrasound versus floroscopy guided pulsed radiofrequency treatment of the lumbar dorsal root ganglion (DRG) of S1 in patients with a chronic lumbosacral radicular pain. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Pain, Chronic
- What is being tested?
- Ultrasound-guided S1 Radiofrequency stimulation and Fluoroscopic-guided S1 Radiofrequency stimulation
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 1 Feb 2022to 20 Oct 2022
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Persistent pain score ≥ 4 on VAS, not responding to traditional treatments
- Radicular pain in lumbar region for 3 months or more,
- Pattern of radiation suggestive for S1 pathology
Who cannot join
- Patient refusal
- Coagulopathy
- Uncooperative patients
- Malignant disorder or currently under treatment for a malignant disorder
- Pregnancy
- Leg pain due to localized hip or knee pathology
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site
Diskapi Yildirim Beyazit Training and Research Hospital
Ankara, 06110
About this study
Official title: Effectiveness of Ultrasound Versus Fluoroscopy Guided S1 Injections and Radiofrequency for the Management of Radicular Pain
The investigators aim to compare the effect of ultrasound versus floroscopy guided pulsed radiofrequency treatment of the lumbar dorsal root ganglion (DRG) of S1 in patients with a chronic lumbosacral radicular pain.
- Conditions
- Pain, Chronic
- Being tested
- Ultrasound-guided S1 Radiofrequency stimulation, Fluoroscopic-guided S1 Radiofrequency stimulation
- Medical subject headings
- Chronic Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Ultrasound-guided S1 Radiofrequency stimulationProcedure or surgery
Pulsed radiofrequency stimulation of the S1 dorsal root ganglia under ultrasound-guidance
Fluoroscopic-guided S1 Radiofrequency stimulationProcedure or surgery
Pulsed radiofrequency stimulation of the S1 dorsal root ganglia under fluoroscopy-guidance
| Study group | Role | What they receive |
|---|---|---|
| Fluoroscopic-guided S1 Radiofrequency stimulation | Active comparator | Not described Receives: Procedure: Fluoroscopic-guided S1 Radiofrequency stimulation |
| Ultrasound-guided S1 Radiofrequency stimulation | Experimental | Not described Receives: Procedure: Ultrasound-guided S1 Radiofrequency stimulation |
What is being measured
The primary outcome is the main question the study is designed to answer.
Pain scores
Visual analog scale (VAS) for pain at the follow-up time periods. The visual analog scale is a numerical scale from 0 to 10; with 0 representing no pain and 10 representing the worst pain imaginable.
Measured: baseline to 6 months post-procedure
Secondary outcomes (2)
Oswestry Disability Index (ODI)
Mean Change from Baseline in functional disability scores based on Oswestry Disability Index. 0% to 20% indicate minimal disability, 21% to 40% indicate moderate disability, 41%-60% indicates severe disability, 61%-80% means crippled and 81%-100% indicates that the patient is either bed-bound or exaggerating his/her symptoms.
Measured: baseline to 6 months post-procedure
Patient satisfaction Questionnaire
Satisfaction was measured on a 1 to 5 scale,Using score: 5-Excellent, 4-Very Good, 3-Good, 2-Fair, and 1-Poor
Measured: baseline to 6 months post-procedure
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Feb 2022
- Study start1 Feb 2022
- Primary completion10 Oct 2022
- Study completion20 Oct 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Pain, ChronicStudies 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
- Triple blind
- Who is masked
- Care provider, Investigator, Outcomes assessor
- Enrolment
- 60 participants (actual)
Sponsor and investigators
- Lead sponsor
- Diskapi Teaching and Research Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Selin Guven Kose, Diskapi Teaching and Research Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05247892
- Sponsor's protocol ID
- 121/12
- Status last verified
- Oct 2022
- First submitted
- 1 Feb 2022
- Last updated
- 2 Nov 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 2 Nov 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effectiveness of Ultrasound Versus Fluoroscopy Guided S1 Injections and Radiofrequency for the Management of Radicular Pain
- ClinicalTrials.gov ID
- NCT05247892
- Acronym / sponsor ID
- 121/12
- Conditions
- Pain, Chronic
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 60 participants (actual)
- Lead sponsor
- Diskapi Teaching and Research HospitalUniversity, hospital or other
- Study start
- 1 Feb 2022 (actual)
- Primary completion
- 10 Oct 2022 (actual)
- Study completion
- 20 Oct 2022 (actual)
- First posted
- 21 Feb 2022 (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 investigators aim to compare the effect of ultrasound versus floroscopy guided pulsed radiofrequency treatment of the lumbar dorsal root ganglion (DRG) of S1 in patients with a chronic lumbosacral radicular pain.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Fluoroscopic-guided S1 Radiofrequency stimulation | Active comparator | Procedure: Fluoroscopic-guided S1 Radiofrequency stimulation |
| Ultrasound-guided S1 Radiofrequency stimulation | Experimental | Procedure: Ultrasound-guided S1 Radiofrequency stimulation |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Persistent pain score ≥ 4 on VAS, not responding to traditional treatments
- Radicular pain in lumbar region for 3 months or more,
- Pattern of radiation suggestive for S1 pathology
Key exclusion criteria (6 listed)
- Patient refusal
- Coagulopathy
- Uncooperative patients
- Malignant disorder or currently under treatment for a malignant disorder
- Pregnancy
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 |
|---|---|---|
| Ultrasound-guided S1 Radiofrequency stimulationPulsed radiofrequency stimulation of the S1 dorsal root ganglia under ultrasound-guidance | Procedure or surgery | Ultrasound-guided S1 Radiofrequency stimulation |
| Fluoroscopic-guided S1 Radiofrequency stimulationPulsed radiofrequency stimulation of the S1 dorsal root ganglia under fluoroscopy-guidance | Procedure or surgery | Fluoroscopic-guided S1 Radiofrequency stimulation |
Primary outcome
Pain scores
Time frame: baseline to 6 months post-procedure
Visual analog scale (VAS) for pain at the follow-up time periods. The visual analog scale is a numerical scale from 0 to 10; with 0 representing no pain and 10 representing the worst pain imaginable.
2 secondary outcomes
Oswestry Disability Index (ODI)
Time frame: baseline to 6 months post-procedure
Patient satisfaction Questionnaire
Time frame: baseline to 6 months post-procedure
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 2 Nov 2022.
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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 Ultrasound-guided S1 Radiofrequency stimulation and Fluoroscopic-guided S1 Radiofrequency stimulation in people with Pain, Chronic, run by Diskapi Teaching and Research 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 2 Nov 2022. 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?
Pain scores (time frame: baseline to 6 months post-procedure). 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 2 Nov 2022.