Cervical PainpulsedrfNCT06298747
Ultrasound-guided Selective Cervical Root Pulsed Radiofrequency Therapy in Patients With Cervical Radicular Pain
An observational study of Cervical Pain, run by Diskapi Teaching and Research Hospital at 1 site in Turkey (Türkiye).
Trial summary
Chronic cervical pain is a common disorder with a prevalence of approximately 35% in adults. Cervical radicular pain is defined as radiating pain in the upper limb caused by compression or inflammation of the nerve roots ascending from the intervertebral foramen to the spinal cord, due to disc herniation or spinal… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Cervical Pain
- What is being tested?
- Selective cervical nerve root pulsed radiofrequency
- How many people
- 45 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 1 Nov 2022to 2 Jul 2023
- Phase
- Observational
- 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
- Adult, Older adult
Study population: Patients with cervical radicular pain unresponsive to conservative treatments
Who may be able to join
- age ≥ 18 years
- radicular pain radiating only to the neck and one arm for more than 12 weeks
- no response to conservative treatment (including analgesics and physiotherapy modalities)
- access to clinical data
Who cannot join
- inadequate medical records with missing Numerical Rating Scale (NRS), Neck Disability Index (NDI), and DN4 (Douleur Neuropathique 4 Questions) scores
- patients lost to follow-up within six months after the procedure
- history of malignancy
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Evaluation of the Efficacy of Ultrasound-guided Selective Cervical Root Pulsed Radiofrequency Therapy in Patients With Cervical Radicular Pain: Analysis of Single-Center Data
Chronic cervical pain is a common disorder with a prevalence of approximately 35% in adults. Cervical radicular pain is defined as radiating pain in the upper limb caused by compression or inflammation of the nerve roots ascending from the intervertebral foramen to the spinal cord, due to disc herniation or spinal stenosis. C7 and C6 are the two most commonly affected nerve roots. Various treatment modalities are available, including oral medications, physiotherapy, and epidural steroid injections. However, chronic and persistent pain that develops as a result of some patients not responding to these treatments. Ultrasound-guided selective cervical nerve root block and pulsed radiofrequency are interventional treatments used in patients with radicular cervical pain unresponsive to conservative treatments. Pulsed radiofrequency (PRF) treatment of peripheral nerves may provide long-term pain relief in patients with short-term pain relief with a local anesthetic block. Studies have shown the effectiveness of PRF therapy applied to selective cervical nerve roots in relieving cervical radicular pain.
Read the detailed description
Pulsed radiofrequency treatment applied to selective cervical nerve roots (C5, C6, and C7) under ultrasound guidance is frequently used in patients with cervical radicular pain due to cervical disc herniation who do not respond adequately to medical treatment and physiotherapy.
Pain intensity was evaluated at baseline and 1,3 and 6 months after US-guided selective cervical nerve root PRF treatment using VAS (Visual analog scale). The primary outcome measure was percent reduction in pain, with 50% pain relief lasting at least 6 months was defined as a positive categorical outcome.
Patients' functionality and neuropathic pain status were assessed using the Neck Disability Index (NDI) and Douleur Neuropathique 4 Questions (DN4) at baseline and 1,3 and 6 months after US-guided selective cervical nerve root PRF treatment, respectively. Secondary outcome measure was defined as a positive categorical outcome of 50% or more improvement in these scores for at least 6 months.
In addition, demographic data such as age (years), gender, duration of pain (months), pain side (right or left), affected cervical nerve root level (one or multiple levels), and history of surgery for cervical disc herniation and analgesic use (nonsteroidal anti-inflammatory drugs or opioids) were obtained from patient data and retrospectively analyzed the patient's electronic medical history records.
The primary aim of this study was to determine the efficacy of US-SCNR PRF treatment, and the clinical and demographic variables associated with treatment outcomes. The secondary aim of this study was to determine the improvement in functionality and neuropathic pain status of patients after the procedure, and treatment-related adverse events.
- Conditions
- Cervical Pain
- Being tested
- Selective cervical nerve root pulsed radiofrequency
- Keywords
- cervical radicular pain, ultrasonography, cervical nerve root, pulsed radiofrequency, analgesia
- Medical subject headings
- Neck Pain, Agnosia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Selective cervical nerve root pulsed radiofrequencyOther
A 5-12 MHz linear US probe was used during the procedure. C7 has a more prominent posterior tubercle and a rudimentary anterior tubercle. C5 and C6 have more prominent and smooth anterior and posterior tubercles, respectively. After visualizing the hypoechoic nerve root between the tubercles of the transverse process, the surrounding vascular structures were identified and RF canula is used. After approaching the hypoechoic nerve root, after sensory and motor stimulation, PRF was applied to each nerve root.
| Study group | Role | What they receive |
|---|---|---|
| Selective cervical nerve root pulsed radiofrequency | A 5-12 MHz linear US probe was used during the procedure. C7 has a more prominent posterior tubercle and a rudimentary anterior tubercle. C5 and C6 have more prominent and smooth anterior and posterior tubercles, respectively. After visualizing the hypoechoic nerve root between the tubercles of the transverse process, the surrounding vascular structures were identified and RF canula is used. After approaching the hypoechoic nerve root, after sensory and motor stimulation, PRF was applied to each nerve root with a current of 1.0-1.2 V at a frequency of 2 Hz for 4 minutes at 42 °C. Receives: Other: Selective cervical nerve root pulsed radiofrequency |
What is being measured
The primary outcome is the main question the study is designed to answer.
VAS
Visual analogue scales (VAS) are psychometric measuring instruments designed to document the characteristics of disease-related symptom severity in individual patients and use this to achieve a rapid (statistically measurable and reproducible) classification of symptom severity and disease control. (minimum value is 0 and maximum value is 10)
Measured: Change from Baseline VAS at 6 months
Secondary outcomes (2)
Neck Disability Index (NDI)
NDI is a self-report questionnaire that measures the impact of neck pain on patient's daily activities and quality of life. It consists of ten items assessing pain intensity, self-care, lifting, reading, headache, concentration, work, driving, sleep, and leisure. Each item is scored between 0 and 5, with higher scores indicating more disability.
Measured: Change from Baseline NDI at 6 months
Douleur Neuropathique 4 Questions (DN4)
The DN4 scale provides information on whether pain has a neuropathic character. It is scored according to the presence of burning, coldness, or electric shock sensation in the pain, tingling, numbness, stinging, or itching sensation in the same region, presence of touch or needle hypoesthesia on examination, and occurrence of pain in the same region with a brush. Although the maximum score was 10, a score >4 indicated the presence of neuropathic pain.
Measured: Change from Baseline NDI at 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Mar 2024
- Study start1 Nov 2022
- Primary completion1 Jul 2023
- Study completion2 Jul 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Cervical 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
- Observational
- Observational model
- Other
- Time perspective
- Retrospective
- Enrolment
- 45 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
- Ömer Taylan Akkaya, MD, Study director, Diskapi Teaching and Research Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06298747
- Sponsor's protocol ID
- Cervical root PRF
- Acronym
- pulsedrf
- Status last verified
- Mar 2024
- First submitted
- 1 Mar 2024
- Last updated
- 15 Mar 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 15 Mar 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of the Efficacy of Ultrasound-guided Selective Cervical Root Pulsed Radiofrequency Therapy in Patients With Cervical Radicular Pain: Analysis of Single-Center Data
- ClinicalTrials.gov ID
- NCT06298747
- Acronym / sponsor ID
- pulsedrf / Cervical root PRF
- Conditions
- Cervical Pain
- Keywords
- cervical radicular pain, ultrasonography, cervical nerve root, pulsed radiofrequency, analgesia
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 45 participants (actual)
- Lead sponsor
- Diskapi Teaching and Research HospitalUniversity, hospital or other
- Study start
- 1 Nov 2022 (actual)
- Primary completion
- 1 Jul 2023 (actual)
- Study completion
- 2 Jul 2023 (actual)
- First posted
- 7 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.
Chronic cervical pain is a common disorder with a prevalence of approximately 35% in adults. Cervical radicular pain is defined as radiating pain in the upper limb caused by compression or inflammation of the nerve roots ascending from the intervertebral foramen to the spinal cord, due to disc herniation or spinal stenosis. C7 and C6 are the two most commonly affected nerve roots. Various treatment modalities are available, including oral medications, physiotherapy, and epidural steroid injections. However, chronic and persistent pain that develops as a result of some patients not responding to these treatments. Ultrasound-guided selective cervical nerve root block and pulsed radiofrequency are interventional treatments used in patients with radicular cervical pain unresponsive to conservative treatments. Pulsed radiofrequency (PRF) treatment of peripheral nerves may provide long-term pain relief in patients with short-term pain relief with a local anesthetic block. Studies have shown the effectiveness of PRF therapy applied to selective cervical nerve roots in relieving cervical radicular pain.
Detailed description
Pulsed radiofrequency treatment applied to selective cervical nerve roots (C5, C6, and C7) under ultrasound guidance is frequently used in patients with cervical radicular pain due to cervical disc herniation who do not respond adequately to medical treatment and physiotherapy.
Pain intensity was evaluated at baseline and 1,3 and 6 months after US-guided selective cervical nerve root PRF treatment using VAS (Visual analog scale). The primary outcome measure was percent reduction in pain, with 50% pain relief lasting at least 6 months was defined as a positive categorical outcome.
Patients' functionality and neuropathic pain status were assessed using the Neck Disability Index (NDI) and Douleur Neuropathique 4 Questions (DN4) at baseline and 1,3 and 6 months after US-guided selective cervical nerve root PRF treatment, respectively. Secondary outcome measure was defined as a positive categorical outcome of 50% or more improvement in these scores for at least 6 months.
In addition, demographic data such as age (years), gender, duration of pain (months), pain side (right or left), affected cervical nerve root level (one or multiple levels), and history of surgery for cervical disc herniation and analgesic use (nonsteroidal anti-inflammatory drugs or opioids) were obtained from patient data and retrospectively analyzed the patient's electronic medical history records.
The primary aim of this study was to determine the efficacy of US-SCNR PRF treatment, and the clinical and demographic variables associated with treatment outcomes. The secondary aim of this study was to determine the improvement in functionality and neuropathic pain status of patients after the procedure, and treatment-related adverse events.
Study design
- Observational model
- Other
- Time perspective
- Retrospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Selective cervical nerve root pulsed radiofrequency | – | Other: Selective cervical nerve root pulsed radiofrequencyA 5-12 MHz linear US probe was used during the procedure. C7 has a more prominent posterior tubercle and a rudimentary anterior tubercle. C5 and C6 have more prominent and smooth anterior and posterior tubercles, respectively. After visualizing the hypoechoic nerve root between the tubercles of the transverse process, the surrounding vascular structures were identified and RF canula is used. After approaching the hypoechoic nerve root, after sensory and motor stimulation, PRF was applied to each nerve root with a current of 1.0-1.2 V at a frequency of 2 Hz for 4 minutes at 42 °C. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Age groups
- Adult, Older adult
- Study population
- Patients with cervical radicular pain unresponsive to conservative treatments
Key inclusion criteria (4 listed)
- age ≥ 18 years
- radicular pain radiating only to the neck and one arm for more than 12 weeks
- no response to conservative treatment (including analgesics and physiotherapy modalities)
- access to clinical data
Key exclusion criteria (3 listed)
- inadequate medical records with missing Numerical Rating Scale (NRS), Neck Disability Index (NDI), and DN4 (Douleur Neuropathique 4 Questions) scores
- patients lost to follow-up within six months after the procedure
- history of malignancy
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 |
|---|---|---|
| Selective cervical nerve root pulsed radiofrequencyA 5-12 MHz linear US probe was used during the procedure. C7 has a more prominent posterior tubercle and a rudimentary anterior tubercle. C5 and C6 have more prominent and smooth anterior and posterior tubercles, respectively. After visualizing the hypoechoic nerve root between the tubercles of the transverse process, the surrounding vascular structures were identified and RF canula is used. After approaching the hypoechoic nerve root, after sensory and motor stimulation, PRF was applied to each nerve root. | Other | Selective cervical nerve root pulsed radiofrequency |
Primary outcome
VAS
Time frame: Change from Baseline VAS at 6 months
Visual analogue scales (VAS) are psychometric measuring instruments designed to document the characteristics of disease-related symptom severity in individual patients and use this to achieve a rapid (statistically measurable and reproducible) classification of symptom severity and disease control. (minimum value is 0 and maximum value is 10)
2 secondary outcomes
Neck Disability Index (NDI)
Time frame: Change from Baseline NDI at 6 months
Douleur Neuropathique 4 Questions (DN4)
Time frame: Change from Baseline NDI at 6 months
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 15 Mar 2024.
- Individual participant dataSharing planned: Undecided
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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 Akkaya, MD study director
Diskapi Teaching and Research Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Cervical Pain, 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 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 15 Mar 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?
VAS (time frame: Change from Baseline VAS at 6 months). 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 15 Mar 2024.