Neck PainNCT05950321
Paramedian CESI vs Selective Nerve Root PRF for Lower Cervical Radicular Pain
A study testing Paramedian cervical epidural steroid injection and Selective nerve root pulsed radiofrequency in people with Neck Pain and Cervical Radiculopathy, run by Diskapi Teaching and Research Hospital at 1 site in Turkey (Türkiye).
Trial summary
This study aims to compare the efficacy of ultrasound-guided selective cervical nerve root pulsed radiofrequency (PRF) versus fluoroscopy-guided paramedian cervical epidural steroid administration (CESI) for the treatment of lower cervical radicular pain refractory to conservative treatments. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Neck Pain, Cervical Radiculopathy
- What is being tested?
- Paramedian cervical epidural steroid injection and Selective nerve root pulsed radiofrequency
- Type of treatment
- Injection or infusion, 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 Aug 2022to 20 Aug 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 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Severe unilateral radicular pain due to cervical disc herniation (pain with a severity of 6 or more on a numeric rating scale of 0-10)
- Continued pain for more than 3 months
- Demonstration of herniated disc compression of the lower cervical spinal nerve roots on magnetic resonance imaging
- Failure in pain management with conservative methods such as analgesics and physical therapy
Who cannot join
- Pain radiating to both arms, hands or neck pain in the foreground
- Spinal stenosis or spondylolisthesis (only those with radicular pain due to disc herniation will be included)
- Cognitive impairment
- Hepatic or renal insufficiency
- Severe psychiatric illness
- Local or systemic infection
- Coagulopathy
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Comparison of Fluoroscopy-guided Cervical Paramedian Interlaminar Epidural Block Versus Ultrasound-guided Selective Nerve Root Pulsed Radiofrequency for the Management of Chronic Lower Cervical Radicular Pain
This study aims to compare the efficacy of ultrasound-guided selective cervical nerve root pulsed radiofrequency (PRF) versus fluoroscopy-guided paramedian cervical epidural steroid administration (CESI) for the treatment of lower cervical radicular pain refractory to conservative treatments. For this evaluation, a numerical rating (NRS), neck disability index (NDI), and Leeds Assessment Of Neuropathic Symptoms And Signs (LANSS) scale will be used before and after both interventions.
Read the detailed description
Chronic cervical radicular pain is a common condition that affects the quality of life of many patients and is caused by compression or irritation of the cervical nerve roots. Treatment options for this condition include conservative methods such as medications and physical therapy, as well as interventions such as surgery or injections.
Two commonly used injections for chronic cervical radicular pain are ultrasound-guided selective nerve root PRF and fluoroscopy-guided paramedian CESI. PRF involves the application of pulsed radiofrequency energy (intermittent current, tissue temperature not exceeding 42 °C) to the cervical nerve root under ultrasound guidance. PRF is a non-destructive technique that modulates the activity of nerve fibers without causing thermal damage. CESI involves injecting local anesthetic and steroids into the epidural space between the laminae of the vertebrae under fluoroscopic guidance. The aim of both techniques is to reduce inflammation and pain transmission from the affected nerve root. The efficacy of both CESI and selective nerve root PRF has been demonstrated in clinical trials.
The primary aim of the investigators in this study is to compare the efficacy of these two treatments. A total of at least 60 patients, 30 patients in each group, will be enrolled for comparison. NRS, NDI, and LANSS scores before, 3 months, and 6 months after treatment will be compared both within and between groups. The secondary aim is to reveal the side effects and adverse events in these two treatment modalities.
- Conditions
- Neck Pain, Cervical Radiculopathy
- Being tested
- Paramedian cervical epidural steroid injection, Selective nerve root pulsed radiofrequency
- Keywords
- Pulsed Radiofrequency Treatment, Fluoroscopy, Steroids
- Medical subject headings
- Neck Pain, Radiculopathy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Paramedian cervical epidural steroid injectionProcedure or surgery
For paramedian cervical epidural steroid injection, the cervical 7 (C7) - thoracic 1 (T1) interval is determined by taking an appropriate angle with C-arm fluoroscopy to determine the interlaminar space from the posterior cervical region. The epidural space is recognized by the negative pressure reflected on the resistance syringe.
Selective nerve root pulsed radiofrequencyProcedure or surgery
For selective nerve root PRF, an 8-12 Hz linear ultrasound probe is first placed posterolateral to the neck. The level of the cervical nerve roots is determined according to the morphology of the anterior and posterior vertebral tubercles. The corresponding nerve root is visualized hypoechoically between the tubercles. The radiofrequency cannula is inserted in the same plane as the ultrasound probe (in plane) and the relevant nerve root is approached. Pulsed radiofrequency current, which has therapeutic properties in chronic pain, is applied to the relevant nerve root for 240 seconds.
| Study group | Role | What they receive |
|---|---|---|
| Cervical epidural group | Active comparator | Paramedian cervical epidural injection for cervical radiculopathy Receives: Procedure: Paramedian cervical epidural steroid injection |
| Radiofrequency group | Active comparator | Pulsed radiofrequency applied to nerve roots for cervical radiculopathy Receives: Procedure: Selective nerve root pulsed radiofrequency |
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 3rd and 6th month after treatment
Secondary outcomes (2)
The Neck Disability Index (NDI)
The Neck Disability Index (NDI) is a widely used questionnaire designed to assess the impact of neck pain on a person's daily functioning and quality of life. It consists of ten questions covering topics such as pain intensity, personal care, lifting, reading, headaches, concentration, work, driving, sleeping, and recreation. Each question has six possible responses, which are assigned a numerical value. By summing up the scores, the NDI provides a measure of the patient's neck disability ranging from 0% (no disability) to 100% (maximum disability).
Measured: Change from baseline to 3rd and 6th month after treatment
Leeds Assessment Of Neuropathic Symptoms And Signs (LANSS)
The Leeds assessment of neuropathic symptoms and signs (LANSS) Pain Scale is based on analysis of sensory description and bedside examination of sensory dysfunction, and provides immediate information in clinical settings. It was developed in two populations of chronic pain patients.
Measured: Change from baseline to 3rd and 6th 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 posted18 Jul 2023
- Study start1 Aug 2022
- Primary completion5 Aug 2023
- Study completion20 Aug 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Neck 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
- 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, Damla Yürük, Diskapi Teaching and Research Hospital
- Investigators
- Gevher Rabia Genc Perdecioğlu, Study chair, Diskapi TRH
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05950321
- Sponsor's protocol ID
- Paramedian cesi vs root prf
- Status last verified
- Sep 2023
- First submitted
- 10 Jul 2023
- Last updated
- 18 Sep 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 18 Sep 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison of Fluoroscopy-guided Cervical Paramedian Interlaminar Epidural Block Versus Ultrasound-guided Selective Nerve Root Pulsed Radiofrequency for the Management of Chronic Lower Cervical Radicular Pain
- ClinicalTrials.gov ID
- NCT05950321
- Acronym / sponsor ID
- Paramedian cesi vs root prf
- Conditions
- Neck Pain, Cervical Radiculopathy
- Keywords
- Pulsed Radiofrequency Treatment, Fluoroscopy, Steroids
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 60 participants (actual)
- Lead sponsor
- Diskapi Teaching and Research HospitalUniversity, hospital or other
- Study start
- 1 Aug 2022 (actual)
- Primary completion
- 5 Aug 2023 (actual)
- Study completion
- 20 Aug 2023 (actual)
- First posted
- 18 Jul 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.
This study aims to compare the efficacy of ultrasound-guided selective cervical nerve root pulsed radiofrequency (PRF) versus fluoroscopy-guided paramedian cervical epidural steroid administration (CESI) for the treatment of lower cervical radicular pain refractory to conservative treatments. For this evaluation, a numerical rating (NRS), neck disability index (NDI), and Leeds Assessment Of Neuropathic Symptoms And Signs (LANSS) scale will be used before and after both interventions.
Detailed description
Chronic cervical radicular pain is a common condition that affects the quality of life of many patients and is caused by compression or irritation of the cervical nerve roots. Treatment options for this condition include conservative methods such as medications and physical therapy, as well as interventions such as surgery or injections.
Two commonly used injections for chronic cervical radicular pain are ultrasound-guided selective nerve root PRF and fluoroscopy-guided paramedian CESI. PRF involves the application of pulsed radiofrequency energy (intermittent current, tissue temperature not exceeding 42 °C) to the cervical nerve root under ultrasound guidance. PRF is a non-destructive technique that modulates the activity of nerve fibers without causing thermal damage. CESI involves injecting local anesthetic and steroids into the epidural space between the laminae of the vertebrae under fluoroscopic guidance. The aim of both techniques is to reduce inflammation and pain transmission from the affected nerve root. The efficacy of both CESI and selective nerve root PRF has been demonstrated in clinical trials.
The primary aim of the investigators in this study is to compare the efficacy of these two treatments. A total of at least 60 patients, 30 patients in each group, will be enrolled for comparison. NRS, NDI, and LANSS scores before, 3 months, and 6 months after treatment will be compared both within and between groups. The secondary aim is to reveal the side effects and adverse events in these two treatment modalities.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Cervical epidural group | Active comparator | Procedure: Paramedian cervical epidural steroid injectionParamedian cervical epidural injection for cervical radiculopathy |
| Radiofrequency group | Active comparator | Procedure: Selective nerve root pulsed radiofrequencyPulsed radiofrequency applied to nerve roots for cervical radiculopathy |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Severe unilateral radicular pain due to cervical disc herniation (pain with a severity of 6 or more on a numeric rating scale of 0-10)
- Continued pain for more than 3 months
- Demonstration of herniated disc compression of the lower cervical spinal nerve roots on magnetic resonance imaging
- Failure in pain management with conservative methods such as analgesics and physical therapy
Key exclusion criteria (7 listed)
- Pain radiating to both arms, hands or neck pain in the foreground
- Spinal stenosis or spondylolisthesis (only those with radicular pain due to disc herniation will be included)
- Cognitive impairment
- Hepatic or renal insufficiency
- Severe psychiatric illness
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 |
|---|---|---|
| Paramedian cervical epidural steroid injectionFor paramedian cervical epidural steroid injection, the cervical 7 (C7) - thoracic 1 (T1) interval is determined by taking an appropriate angle with C-arm fluoroscopy to determine the interlaminar space from the posterior cervical region. The epidural space is recognized by the negative pressure reflected on the resistance syringe. | Procedure or surgery | Cervical epidural group |
| Selective nerve root pulsed radiofrequencyFor selective nerve root PRF, an 8-12 Hz linear ultrasound probe is first placed posterolateral to the neck. The level of the cervical nerve roots is determined according to the morphology of the anterior and posterior vertebral tubercles. The corresponding nerve root is visualized hypoechoically between the tubercles. The radiofrequency cannula is inserted in the same plane as the ultrasound probe (in plane) and the relevant nerve root is approached. Pulsed radiofrequency current, which has therapeutic properties in chronic pain, is applied to the relevant nerve root for 240 seconds. | Procedure or surgery | Radiofrequency group |
Primary outcome
Numerical rating scale (NRS)
Time frame: Change from baseline to 3rd and 6th month after treatment
NRS is a scale that can be used measuring pain. Scores range from 0 (no pain) to 10 (the worst pain)
2 secondary outcomes
The Neck Disability Index (NDI)
Time frame: Change from baseline to 3rd and 6th month after treatment
Leeds Assessment Of Neuropathic Symptoms And Signs (LANSS)
Time frame: Change from baseline to 3rd and 6th month after treatment
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 18 Sep 2023.
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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.
Gevher Rabia Genc Perdecioğlu study chair
Diskapi TRH
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Paramedian cervical epidural steroid injection and Selective nerve root pulsed radiofrequency in people with Neck Pain and Cervical Radiculopathy, 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 4 inclusion and 7 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 18 Sep 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?
Numerical rating scale (NRS) (time frame: Change from baseline to 3rd and 6th 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 18 Sep 2023.