Spinal Stenosis LumbarNCT06393959
Relief of Lumbar Spinal Stenosis Symptoms
A study testing Caudal epidural pulsed radiofrequency and Caudal epidural steroid enjection in people with Spinal Stenosis Lumbar and Low Back Pain, run by Diskapi Teaching and Research Hospital at 2 sites in Turkey (Türkiye).
Trial summary
The aim of this study was to compare the efficacy of caudal epidural steroid injection and caudal epidural pulsed radiofrequency stimulation in the relief of symptoms of lumbar spinal stenosis. Read more about this study
- Who is it for?
- Ages 18 to 90 years
- Conditions the study is for
- Spinal Stenosis Lumbar, Low Back Pain
- What is being tested?
- Caudal epidural pulsed radiofrequency and Caudal epidural steroid enjection
- Type of treatment
- Injection or infusion, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 50 participants
- Where
- 2 sitesTurkey (Türkiye)
- Study dates
- 15 Feb 2024to 20 Jul 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 90 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Among the patients with lumbar spinal stenosis findings and narrowing of the spinal canal detected by examination and imaging methods, those whose back and leg pain persists for at least 3 months
Who cannot join
- Previous lumbar surgery, pregnancy, history of ongoing malignant disease, autoimmune diseases, active infection of the injection site, hematologic disorders, antiplatelet drug use
Trial locations and contacts
2 sites in 1 country.
Turkey (Türkiye)2 sites, 2 recruiting
- Recruiting
Damla Yürük
Ankara, Türkiye, 5319932
- Recruiting
Ankara Etlik City Hospital
Ankara, Yenimahalle, 5319932
DAMLA YÜRÜK, 095319932378, damlayuruk@hotmail.com
About this study
Official title: Comparison of Pulsed Radiofrequency Stimulation Versus Dexamethasone Applied to the Caudal Epidural Space for the Relief of Lumbar Spinal Stenosis Symptoms
The aim of this study was to compare the efficacy of caudal epidural steroid injection and caudal epidural pulsed radiofrequency stimulation in the relief of symptoms of lumbar spinal stenosis.
This evaluation used the numerical rating scale (NRS) to assess pain relief and the Medication Quantification Scale III (MQS III) to assess the effectiveness of the interventions on medication consumption. The rates of adverse events related to the interventions were also compared.
Read the detailed description
Low back pain (LBP) is one of the leading causes of disability worldwide. Lumbar spinal stenosis is one of the three most common diagnoses of lower back and leg pain, along with intervertebral disc herniation and degenerative spondylolisthesis. Numerous treatment modalities have been proposed for the management of lumbar spinal stenosis, including drug therapy and complex surgical fusion. Epidural injections are a nonsurgical intervention commonly used in the treatment of spinal stenosis. Saline, local anesthetics, steroids, hylaze, platelet-rich plasma, and pulsed radiofrequency (PRF) administered to the caudal epidural space have been reported to be effective in the treatment of pain.
Among these, caudal epidural PRF has been applied in a limited number of chronic painful conditions (failed back surgery syndrome, chronic distal symmetrical polyneuropathy, postherpetic neuralgia, and coccygodynia), and no randomized controlled studies have been conducted. PRF produces a nonthermal effect that modulates the transmission of pain signals by delivering a short-term high-voltage electric current to the target nerve. RFT provides a continuous current that heats the target tissue and causes coagulation necrosis in nerves.
The primary aim of this study was to compare the efficacy of caudal epidural RFT and caudal epidural steroid injections in patients with lumbar spinal stenosis. The secondary aim was to determine the effects of the interventions on drug consumption and interventional safety, based on adverse events.
A total of at least 50 patients will be enrolled for comparison, with 25 in each group. NRS and MQS III scores will be compared both within and between groups before and 1, 2, and 3 months after treatment.
- Conditions
- Spinal Stenosis Lumbar, Low Back Pain
- Being tested
- Caudal epidural pulsed radiofrequency, Caudal epidural steroid enjection
- Keywords
- Pulsed Radiofrequency Treatment, Lomber spinal Stenosis, Caudal epidural steroid injection
- 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.
Caudal epidural pulsed radiofrequencyProcedure or surgery
The patient lied in prone position. After cutaneous and subcutaneous anesthesia with 3 ml of 2% lidocaine, a 22- gauge 150-mm RF cannula with 20 mm active tip was advanced through the sacrococcygeal ligament into the caudal epidural space under floroscopic guidence. A few milliliters contrast was injected to observe the expansion of the epidural space. After correct needle placement was confirmed, an electrode was connected to the cannula, and stimulation was conducted with impedance measured between 250 and 350 Ohms A different sensation or feeling such as fullness, impression, tingling, pulling or plethora at the rectal and/or coccygeal region was observed by the patients when 50 Hz was applied with 0,4 to 0,7 V sensory stimulation. No leg muscle contraction was observed with 2 Hz motor stimulation at 2 V. PRF was performed for 600 s at 5 Hz using a 5-ms pulse width at 55 V, avoiding electrode tip temperatures above 42 C.
Caudal epidural steroid enjectionProcedure or surgery
The patient lied in prone position and aseptic techniques were adopted. After cutaneous and subcutaneous anesthesia with 3 ml of 2% lidocaine, a spinal needle was advanced through the sacrococcygeal ligament into the caudal epidural space under fluoroscopic guidance. The needle tip was confirmed by negative aspiration for blood or cerebrospinal fluid, then a few milliliters of contrast was injected to observe the expansion of the epidural space. After correct needle placement was confirmed, a total of 10 ml mixture of saline and 8 mg dexametzone was administered into the epidural space.
| Study group | Role | What they receive |
|---|---|---|
| pulsed radiofrequency group | Active comparator | Caudal epidural pulsed radiofrequency for lumbar spinal stenosis Receives: Procedure: Caudal epidural pulsed radiofrequency |
| steroid enjection grroup | Active comparator | Caudal epidural steroid enjection for lumbar spinal stenosis Receives: Procedure: Caudal epidural steroid enjection |
What is being measured
The primary outcome is the main question the study is designed to answer.
Numerical rating scale (NRS)
NRS is a scale that can be used measuring pain. Scores range from 0 (no pain) to 10 (the worst pain)
Measured: Change from baseline to 1st,2nd and 3th month after treatment
Secondary outcomes (1)
The Medication Quantification Scale III (MQS III)
The MQS III is a validated tool in medical research that quantifies medication regimens by assigning a numerical value to each medication based on its class, dosage, and associated risks. This scale aids clinicians and researchers in tracking changes in pain levels throughout a treatment course or study, providing an objective measure of medication consumption and its potential negative impact.
Measured: Change from baseline to 1st,2nd and 3th month after treatment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 May 2024
- Study start15 Feb 2024
- Primary completion19 Jul 2024 (estimated)
- Study completion20 Jul 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Spinal Stenosis LumbarStudies 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
- Outcomes assessor
- Enrolment
- 50 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Diskapi Teaching and Research Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Damla Yürük, Diskapi Teaching and Research Hospital
- Investigators
- Ömer Taylan T Akkaya, Prof, Principal investigator, Department of Algology, Ankara Etlik City Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06393959
- Sponsor's protocol ID
- Spinal Stenosis
- Status last verified
- Jul 2024
- First submitted
- 27 Apr 2024
- Last updated
- 22 Jul 2024
- 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 22 Jul 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison of Pulsed Radiofrequency Stimulation Versus Dexamethasone Applied to the Caudal Epidural Space for the Relief of Lumbar Spinal Stenosis Symptoms
- ClinicalTrials.gov ID
- NCT06393959
- Acronym / sponsor ID
- Spinal Stenosis
- Conditions
- Spinal Stenosis Lumbar, Low Back Pain
- Keywords
- Pulsed Radiofrequency Treatment, Lomber spinal Stenosis, Caudal epidural steroid injection
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 50 participants (estimated)
- Lead sponsor
- Diskapi Teaching and Research HospitalUniversity, hospital or other
- Study start
- 15 Feb 2024 (actual)
- Primary completion
- 19 Jul 2024 (estimated)
- Study completion
- 20 Jul 2024 (estimated)
- First posted
- 1 May 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.
The aim of this study was to compare the efficacy of caudal epidural steroid injection and caudal epidural pulsed radiofrequency stimulation in the relief of symptoms of lumbar spinal stenosis.
This evaluation used the numerical rating scale (NRS) to assess pain relief and the Medication Quantification Scale III (MQS III) to assess the effectiveness of the interventions on medication consumption. The rates of adverse events related to the interventions were also compared.
Detailed description
Low back pain (LBP) is one of the leading causes of disability worldwide. Lumbar spinal stenosis is one of the three most common diagnoses of lower back and leg pain, along with intervertebral disc herniation and degenerative spondylolisthesis. Numerous treatment modalities have been proposed for the management of lumbar spinal stenosis, including drug therapy and complex surgical fusion. Epidural injections are a nonsurgical intervention commonly used in the treatment of spinal stenosis. Saline, local anesthetics, steroids, hylaze, platelet-rich plasma, and pulsed radiofrequency (PRF) administered to the caudal epidural space have been reported to be effective in the treatment of pain.
Among these, caudal epidural PRF has been applied in a limited number of chronic painful conditions (failed back surgery syndrome, chronic distal symmetrical polyneuropathy, postherpetic neuralgia, and coccygodynia), and no randomized controlled studies have been conducted. PRF produces a nonthermal effect that modulates the transmission of pain signals by delivering a short-term high-voltage electric current to the target nerve. RFT provides a continuous current that heats the target tissue and causes coagulation necrosis in nerves.
The primary aim of this study was to compare the efficacy of caudal epidural RFT and caudal epidural steroid injections in patients with lumbar spinal stenosis. The secondary aim was to determine the effects of the interventions on drug consumption and interventional safety, based on adverse events.
A total of at least 50 patients will be enrolled for comparison, with 25 in each group. NRS and MQS III scores will be compared both within and between groups before and 1, 2, and 3 months after treatment.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| pulsed radiofrequency group | Active comparator | Procedure: Caudal epidural pulsed radiofrequencyCaudal epidural pulsed radiofrequency for lumbar spinal stenosis |
| steroid enjection grroup | Active comparator | Procedure: Caudal epidural steroid enjectionCaudal epidural steroid enjection for lumbar spinal stenosis |
Who may qualify
- Ages
- 18 to 90 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Among the patients with lumbar spinal stenosis findings and narrowing of the spinal canal detected by examination and imaging methods, those whose back and leg pain persists for at least 3 months
Key exclusion criteria (1 listed)
- Previous lumbar surgery, pregnancy, history of ongoing malignant disease, autoimmune diseases, active infection of the injection site, hematologic disorders, antiplatelet drug use
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 |
|---|---|---|
| Caudal epidural pulsed radiofrequencyThe patient lied in prone position. After cutaneous and subcutaneous anesthesia with 3 ml of 2% lidocaine, a 22- gauge 150-mm RF cannula with 20 mm active tip was advanced through the sacrococcygeal ligament into the caudal epidural space under floroscopic guidence. A few milliliters contrast was injected to observe the expansion of the epidural space. After correct needle placement was confirmed, an electrode was connected to the cannula, and stimulation was conducted with impedance measured between 250 and 350 Ohms A different sensation or feeling such as fullness, impression, tingling, pulling or plethora at the rectal and/or coccygeal region was observed by the patients when 50 Hz was applied with 0,4 to 0,7 V sensory stimulation. No leg muscle contraction was observed with 2 Hz motor stimulation at 2 V. PRF was performed for 600 s at 5 Hz using a 5-ms pulse width at 55 V, avoiding electrode tip temperatures above 42 C. | Procedure or surgery | pulsed radiofrequency group |
| Caudal epidural steroid enjectionThe patient lied in prone position and aseptic techniques were adopted. After cutaneous and subcutaneous anesthesia with 3 ml of 2% lidocaine, a spinal needle was advanced through the sacrococcygeal ligament into the caudal epidural space under fluoroscopic guidance. The needle tip was confirmed by negative aspiration for blood or cerebrospinal fluid, then a few milliliters of contrast was injected to observe the expansion of the epidural space. After correct needle placement was confirmed, a total of 10 ml mixture of saline and 8 mg dexametzone was administered into the epidural space. | Procedure or surgery | steroid enjection grroup |
Primary outcome
Numerical rating scale (NRS)
Time frame: Change from baseline to 1st,2nd and 3th month after treatment
NRS is a scale that can be used measuring pain. Scores range from 0 (no pain) to 10 (the worst pain)
1 secondary outcome
The Medication Quantification Scale III (MQS III)
Time frame: Change from baseline to 1st,2nd and 3th month after treatment
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Jul 2024.
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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.
Ömer Taylan T Akkaya, Prof principal investigator
Department of Algology, Ankara Etlik City Hospital
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Caudal epidural pulsed radiofrequency and Caudal epidural steroid enjection in people with Spinal Stenosis Lumbar and Low Back Pain, run by Diskapi Teaching and Research Hospital at 2 sites 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 1 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: status not confirmed, as of the sponsor's last update on 22 Jul 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Damla T Yürük, MD (095319932378, dr.taylanakkaya@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Numerical rating scale (NRS) (time frame: Change from baseline to 1st,2nd and 3th month after treatment). 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 22 Jul 2024.