Neck PainNCT03066960
Radiofrequency Neurotomy for Chronic Facet Joint Related Neck Pain
A study testing Radiofrequency neurotomy in people with Neck Pain, run by Oslo University Hospital at 2 sites in Norway.
Trial summary
This is a single-center, double blind, sham-controlled randomized trial (N: 34) to assess the long term efficacy of RF neurotomy of cervical medial branches. Patients with chronic unilateral neck pain who are found eligible and achieve ≥50% pain relief of two predictive and comparative test blocks will be included in… Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Neck Pain
- What is being tested?
- Radiofrequency neurotomy
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 34 participants
- Where
- 2 sitesNorway
- Study dates
- 1 Jan 2019to 14 Dec 2025
- 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
- Min 18 years and Maximum 80 years
- Read and understand Norwegian
- Stable neck pain >12 months, with or without unilateral headache
- Average of worst pain intensity last three days ≥ 4 out of maximum 10
- Neck Disability Index >15 points or > 30 percentage points.
- At least two predictive blocks ≥ 50% pain relief 30 to 60 minutes after lidocaine and 30 to 180 minutes after bupivacaine .
Who cannot join
- Serious cervical pathology (acute cervical disc herniation, radiculopathy, myelopathy, spinal anomalies and chronic widespread pain
- Opioid consumption > 50 morphine equivalents/day
- Ongoing litigation process and applying for disability insurance/benefits
- Serious psychiatric disorder (DSM-IV-TR) diagnosed at a psychiatric unit, including suicidal thoughts and somatization (from Hopkins Symptom Check List 25 ≥ 2.5)
- Ongoing addictive behavior ( diagnostic criteria in Statistical Manual, 4th Edition)
- Unstable medical condition (ASA 4, serious vascular disease like unstable angina)
Show all 13Show fewer
- Bacterial infection
- Malignancy
- Chronic generalized pain
- Hypersensitive to contrast agents or local anesthetics
- Pregnancy
- Bleeding diathesis
- Previously radiofrequency neurotomy
Trial locations and contacts
2 sites in 1 country.
Norway2 sites, 2 recruiting
- Recruiting
Department of Pain Management and Research Oslo University Hospital
Oslo, 4950
Gunnvald Kvarstein, PhD, +47923026161, gunnvald.kvarstein@uit.no
Bård Lundeland, PhD, 4+4723026161, bard.lundeland@ous-hf.no
- Recruiting
Department for Pain and Complex Disorders
Trondheim, Torgarden, 3250
Petter Borchgrevink, PhD, +4772822500, petter.borchgrevink@ntnu.no
About this study
Official title: Long-term Efficacy of Radiofrequency Neurotomy for Chronic Zygapophysial (Facet) Joint Related Neck Pain
This is a single-center, double blind, sham-controlled randomized trial (N: 34) to assess the long term efficacy of RF neurotomy of cervical medial branches. Patients with chronic unilateral neck pain who are found eligible and achieve ≥50% pain relief of two predictive and comparative test blocks will be included in the trial in a primary analysis. We will further test whether a strict selection of ≥80% pain relief better predicts efficacious RF neurotomy compared with a less strict selection of ≥50% to <80%. After 6 months sham-treated patients may also be offered active unblinded RF treatment. Demographic and clinical data will be recorded at baseline while primary and secondary outcome measurements are recollected after 1, 3, 6, 9 and 12 months. Primary outcome measurements include self-reported neck function (NDI) and pain relief after 6 months.
Read the detailed description
Chronic neck pain represents a common health problem. The mechanisms appear to be multifactorial. Researchers have suggested a disturbed interplay between the deep neck muscles and facet joints. In Europe and the US radiofrequency neurotomy has become a common treatment. The evidence base, however, is still insufficient. Thus, a double blind, sham-controlled, randomized, single-center trial is carried out. Based on current data and a single center study design, 34 randomized participants, completing the trial, have shown adequate to obtain sufficient statistical power. To simplify the data collection a digital internet based program is used. Patients with chronic unilateral neck pain, referred to Oslo University Hospital or responding to public announcements, and not responding to non-interventional treatment will be screened. Those who are found eligible and achieve ≥50% pain relief after predictive and comparative test blocks, will be included in the study. We will further test whether a strict selection of ≥80% pain relief better predicts efficacious RF neurotomy compared with a less strict selection of ≥50% to <80%. After 6 months participants who received sham and still suffer from neck pain, will be offered unblinded RF neurotomy and additional 12 month unblinded follow up if the results support this treatment. Demographic and clinical data will be recorded at baseline. The primary and secondary outcome measurements are recollected after 1, 3, 6, 9 and 12 months. Primary outcome measurements include self-reported neck function (NDI) and pain relief after 6 months. Regression analyses will be used to identify how pain relief of two test blocks and pain catastrophizing predict response to RF neurotomy. If RF neurotomy is found superior to sham treatment, this may be implemented in the national treatment program for selected patients with chronic neck pain.
- Conditions
- Neck Pain
- Being tested
- Radiofrequency neurotomy, Sham treatment
- Keywords
- radiofrequency neurotomy, zygapophyseal joint
- Medical subject headings
- Neck Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Radiofrequency neurotomyProcedure or surgery
RF neurotomy represents a nerve destructive, coagulating technique affecting the conduction through all nerve fibers.
Sham treatmentProcedure or surgery
Sham treatment represents no coagulation of the nerve and will not affect the nerve conduction.
| Study group | Role | What they receive |
|---|---|---|
| Radiofrequency neurotomy group | Active comparator | Unilateral radiofrequency neurotomy of medial branches to the dorsal ramus at one or two cervical levels Receives: Procedure: Radiofrequency neurotomy |
| Sham group | Sham comparator | Unilateral sham treatment of medial branches to the dorsal ramus at one or two cervical levels Receives: Procedure: Sham treatment |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in neck function after RF neurotomy vs sham treatment
Two independent group comparison of change of Neck Disability Index scores -continuous variable 0-50)
Measured: 6 months
Change in pain intensity (numeric pain scale) after RF neurotomy vs sham treatment
Two independent group comparison of change in pain intensity (triplicate values from three consecutive days on a numeric pain scale 0-10 which provides a continuous variable)
Measured: 6 months
Secondary outcomes (27)
Change in neck function after RF neurotomy vs sham treatment
Two independent group comparison of change of Neck Disability Index scores -continuous variable 0-50
Measured: 12 months
Change in pain intensity (numeric pain scale) after RF neurotomy vs sham treatment
Two independent group comparison of change in pain intensity (triplicate values from three consecutive days on a numeric pain scale 0-10 which provides a continuous variable)
Measured: 1 month
Change in pain intensity (numeric pain scale) after RF neurotomy vs sham treatment
Two independent group comparison of change in pain intensity (triplicate values from three consecutive days on a numeric pain scale 0-10 which provides a continuous variable)
Measured: 3 months
Change in pain intensity (numeric pain scale) after RF neurotomy vs sham treatment
Two independent group comparison of change in pain intensity (triplicate values from three consecutive days on a numeric pain scale 0-10 which provides a continuous variable)
Measured: 9 months
Change in pain intensity (numeric pain scale) after RF neurotomy vs sham treatment
Two independent group comparison of change in pain intensity (triplicate values from three consecutive days on a numeric pain scale 0-10 which provides a continuous variable)
Measured: 12 months
Change in pain intensity (categorical pain scale) after RF neurotomy vs sham treatment
Two independent group comparison of change in pain intensity (categorical 6-point pain scale with the alternatives worse, unchanged, <50% reduced, ≥50% reduced, and pain free which provides a categorial variable)
Measured: 1 month
Change in pain intensity (categorical pain scale) after RF neurotomy vs sham treatment
Two independent group comparison of change in pain intensity (categorical 6-point pain scale wth the alternatives worse, unchanged, <50% reduced, ≥50% reduced, and pain free which provides a categorial variable)
Measured: 3 months
Change in pain intensity (categorical pain scale) after RF neurotomy vs sham treatment
Two independent group comparison of change in pain intensity (categorical 6-point pain scale wth the alternatives worse, unchanged, <50% reduced, ≥50% reduced, and pain free which provides a categorial variable)
Measured: 6 months
Change in pain intensity (categorical pain scale) after RF neurotomy vs sham treatment
Two independent group comparison of change in pain intensity (categorical 6-point pain scale wth the alternatives worse, unchanged, <50% reduced, ≥50% reduced, and pain free which provides a categorial variable)
Measured: 9 months
Change in pain intensity (categorical pain scale) after RF neurotomy vs sham treatment
Two independent group comparison of change in pain intensity (categorical 6-point pain scale wth the alternatives worse, unchanged, <50% reduced, ≥50% reduced, and pain free which provides a categorial variable)
Measured: 12 months
Change in health related quality of life after RF neurotomy vs sham treatment
Two independent group comparison of change of EuroQuol-5-Dimensions Index scores (continuous variable from -0.59 to 1.00)
Measured: 6 months
Change in health related quality of life after RF neurotomy vs sham treatment
Two independent group comparison of change of EuroQuol-5-Dimensions Index scores (continuous variable from -0.59 to 1.00)
Measured: 12 months
Change in drug consumption after RF neurotomy vs sham treatment
Two independent group comparison of change of the numbers of analgesic drugs (continuous variable)
Measured: 6 months
Change in drug consumption after RF neurotomy vs sham treatment
Two independent group comparison of change of the numbers of analgesic drugs (continuous variable)
Measured: 12 months
Change in number of neck/pain treatments after RF neurotomy vs sham treatment
Two independent group comparison of change of the numbers of neck/pain treatments (continuous variable)
Measured: 6 months
How highly positive response to test block influences neck function after RF treatment
Regression analysis on how ≥80% pain relief (independent categorical variable) predicts >15% reduction of Neck disability Score (categorical variable) after RF neurotomy
Measured: 6 months
How moderately positive response to test block influences neck function after RF treatment
Regression analysis on how ≥50% and <80% pain relief (independent categorical variable) predicts >15% reduction of Neck disability Score (categorical variable) after RF neurotomy
Measured: 6 months
How highly positive response to test block influences 30% pain relief after RF treatment
Regression analysis on how ≥80% pain relief (independent categorical variable) predicts >30% reduction in pain intensity (categorical variable) after RF neurotomy
Measured: 6 months
How moderately positive response to test block influences 30% pain relief after RF treatment
Regression analysis on how ≥50% and <80% pain relief (independent categorical variable) predicts >30% reduction in pain intensity (categorical variable) after RF neurotomy
Measured: 6 months
How highly positive response to test block influences 50% pain relief after RF treatment
Regression analysis on how ≥80% pain relief (independent categorical variable) predicts >50% reduction in pain intensity (categorical variable) after RF neurotomy
Measured: 6 months
How moderately positive response to test block influences 50% pain relief after RF treatment
Regression analysis on how ≥50 and <80% pain relief (independent categorical variable) predicts >50% reduction in pain intensity (categorical variable) after RF neurotomy
Measured: 6 months
How catastrophizing influences neck function after RF treatment.
Regression analysis on how Pain Catastrophizing Scale score ≥30 (independent categorical variable) predict ≥ 15% reduction of Neck Disability Score (categorical variable) after RF neurotomy vs Pain Catastrophizing Scale score < 30
Measured: 6 months
How catastrophizing influences pain relief after RF treatment.
Regression analysis on how Pain Catastrophizing Scale scores ≥30 (independent categorical variable) predict >30% reduction in pain intensity (categorical variable) after RF neurotomy vs Pain Catastrophizing Scale scores < 30
Measured: 6 months
Change in mental distress after RF neurotomy vs sham treatment.
Two independent group comparison of change in Hopkin Symptom Check List (HSCL 25) sumscore which is a continuous variable on anxiety and depressive symptoms, ranging from 1 (normal) to 4 (worse)
Measured: 6 months
Change in mental distress after RF neurotomy vs sham treatment.
Two independent group comparison of change in Hopkin Symptom Check List (HSCL 25) sumscore which is a continuous variable on anxiety and depressive symptoms, ranging from 1 (normal) to 4 (worse)
Measured: 12 months
Change in sleep disturbances after RF neurotomy vs sham treatment.
Two independent group comparison of change in sleep. Sleep Subscale in Neck Disability Index part 7. A continuous variable based on a 6 point scale ranging from 0 to 6 where 0 is no problem and 6 i severe insomnia.
Measured: 6 months
Change in sleep disturbances after RF neurotomy vs sham treatment.
Two independent group comparison of change in sleep. Sleep Subscale in Neck Disability Index part 7. A continuous variable based on a 6 point scale ranging from 0 to 6 where 0 is no problem and 6 i severe insomnia.
Measured: 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Mar 2017
- Study start1 Jan 2019
- Primary completion14 Dec 2024 (estimated)
- Study completion14 Dec 2025 (estimated)
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.
- More trials run by Oslo University HospitalThe sponsor's other registered studies.
- 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
- Participant, Investigator, Outcomes assessor
- Enrolment
- 34 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Oslo University Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- St. Olavs Hospital
- Responsible party
- Principal investigator, Gunnvald Kvarstein, Oslo University Hospital
- Investigators
- Gunnvald Kvarstein, Dr. Med, Principal investigator, Oslo University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03066960
- Sponsor's protocol ID
- 2015/2194
- Status last verified
- Dec 2023
- First submitted
- 20 Feb 2017
- Last updated
- 11 Dec 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: Individual Participant Data Sharing Plan. In accordance with the general data sharing policy at OUH, the deidentified, individual data can be made available for external researchers from 9 months to 5 years after publication. However, to get access the researchers need to provide a methodologically sound proposal in accordance with the institutional guidelines and sign a data access agreement.
Study at a glance
From the registry record, last updated by the sponsor on 11 Dec 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Long-term Efficacy of Radiofrequency Neurotomy for Chronic Zygapophysial (Facet) Joint Related Neck Pain
- ClinicalTrials.gov ID
- NCT03066960
- Acronym / sponsor ID
- 2015/2194
- Conditions
- Neck Pain
- Keywords
- radiofrequency neurotomy, zygapophyseal joint
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 34 participants (estimated)
- Lead sponsor
- Oslo University HospitalUniversity, hospital or other
- Collaborators
- St. Olavs Hospital
- Study start
- 1 Jan 2019 (actual)
- Primary completion
- 14 Dec 2024 (estimated)
- Study completion
- 14 Dec 2025 (estimated)
- First posted
- 1 Mar 2017 (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 is a single-center, double blind, sham-controlled randomized trial (N: 34) to assess the long term efficacy of RF neurotomy of cervical medial branches. Patients with chronic unilateral neck pain who are found eligible and achieve ≥50% pain relief of two predictive and comparative test blocks will be included in the trial in a primary analysis. We will further test whether a strict selection of ≥80% pain relief better predicts efficacious RF neurotomy compared with a less strict selection of ≥50% to <80%. After 6 months sham-treated patients may also be offered active unblinded RF treatment. Demographic and clinical data will be recorded at baseline while primary and secondary outcome measurements are recollected after 1, 3, 6, 9 and 12 months. Primary outcome measurements include self-reported neck function (NDI) and pain relief after 6 months.
Detailed description
Chronic neck pain represents a common health problem. The mechanisms appear to be multifactorial. Researchers have suggested a disturbed interplay between the deep neck muscles and facet joints. In Europe and the US radiofrequency neurotomy has become a common treatment. The evidence base, however, is still insufficient. Thus, a double blind, sham-controlled, randomized, single-center trial is carried out. Based on current data and a single center study design, 34 randomized participants, completing the trial, have shown adequate to obtain sufficient statistical power. To simplify the data collection a digital internet based program is used. Patients with chronic unilateral neck pain, referred to Oslo University Hospital or responding to public announcements, and not responding to non-interventional treatment will be screened. Those who are found eligible and achieve ≥50% pain relief after predictive and comparative test blocks, will be included in the study. We will further test whether a strict selection of ≥80% pain relief better predicts efficacious RF neurotomy compared with a less strict selection of ≥50% to <80%. After 6 months participants who received sham and still suffer from neck pain, will be offered unblinded RF neurotomy and additional 12 month unblinded follow up if the results support this treatment. Demographic and clinical data will be recorded at baseline. The primary and secondary outcome measurements are recollected after 1, 3, 6, 9 and 12 months. Primary outcome measurements include self-reported neck function (NDI) and pain relief after 6 months. Regression analyses will be used to identify how pain relief of two test blocks and pain catastrophizing predict response to RF neurotomy. If RF neurotomy is found superior to sham treatment, this may be implemented in the national treatment program for selected patients with chronic neck pain.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Radiofrequency neurotomy group | Active comparator | Procedure: Radiofrequency neurotomyUnilateral radiofrequency neurotomy of medial branches to the dorsal ramus at one or two cervical levels |
| Sham group | Sham comparator | Procedure: Sham treatmentUnilateral sham treatment of medial branches to the dorsal ramus at one or two cervical levels |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Min 18 years and Maximum 80 years
- Read and understand Norwegian
- Stable neck pain >12 months, with or without unilateral headache
- Average of worst pain intensity last three days ≥ 4 out of maximum 10
- Neck Disability Index >15 points or > 30 percentage points.
Key exclusion criteria (13 listed)
- Serious cervical pathology (acute cervical disc herniation, radiculopathy, myelopathy, spinal anomalies and chronic widespread pain
- Opioid consumption > 50 morphine equivalents/day
- Ongoing litigation process and applying for disability insurance/benefits
- Serious psychiatric disorder (DSM-IV-TR) diagnosed at a psychiatric unit, including suicidal thoughts and somatization (from Hopkins Symptom Check List 25 ≥ 2.5)
- Ongoing addictive behavior ( diagnostic criteria in Statistical Manual, 4th Edition)
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 |
|---|---|---|
| Radiofrequency neurotomyRF neurotomy represents a nerve destructive, coagulating technique affecting the conduction through all nerve fibers. | Procedure or surgery | Radiofrequency neurotomy group |
| Sham treatmentSham treatment represents no coagulation of the nerve and will not affect the nerve conduction. | Procedure or surgery | Sham group |
Primary outcome
Change in neck function after RF neurotomy vs sham treatment
Time frame: 6 months
Two independent group comparison of change of Neck Disability Index scores -continuous variable 0-50)
Change in pain intensity (numeric pain scale) after RF neurotomy vs sham treatment
Time frame: 6 months
Two independent group comparison of change in pain intensity (triplicate values from three consecutive days on a numeric pain scale 0-10 which provides a continuous variable)
27 secondary outcomes
Change in neck function after RF neurotomy vs sham treatment
Time frame: 12 months
Change in pain intensity (numeric pain scale) after RF neurotomy vs sham treatment
Time frame: 1 month
Change in pain intensity (numeric pain scale) after RF neurotomy vs sham treatment
Time frame: 3 months
Change in pain intensity (numeric pain scale) after RF neurotomy vs sham treatment
Time frame: 9 months
Change in pain intensity (numeric pain scale) after RF neurotomy vs sham treatment
Time frame: 12 months
Change in pain intensity (categorical pain scale) after RF neurotomy vs sham treatment
Time frame: 1 month
Change in pain intensity (categorical pain scale) after RF neurotomy vs sham treatment
Time frame: 3 months
Change in pain intensity (categorical pain scale) after RF neurotomy vs sham treatment
Time frame: 6 months
Change in pain intensity (categorical pain scale) after RF neurotomy vs sham treatment
Time frame: 9 months
Change in pain intensity (categorical pain scale) after RF neurotomy vs sham treatment
Time frame: 12 months
Change in health related quality of life after RF neurotomy vs sham treatment
Time frame: 6 months
Change in health related quality of life after RF neurotomy vs sham treatment
Time frame: 12 months
Change in drug consumption after RF neurotomy vs sham treatment
Time frame: 6 months
Change in drug consumption after RF neurotomy vs sham treatment
Time frame: 12 months
Change in number of neck/pain treatments after RF neurotomy vs sham treatment
Time frame: 6 months
How highly positive response to test block influences neck function after RF treatment
Time frame: 6 months
How moderately positive response to test block influences neck function after RF treatment
Time frame: 6 months
How highly positive response to test block influences 30% pain relief after RF treatment
Time frame: 6 months
How moderately positive response to test block influences 30% pain relief after RF treatment
Time frame: 6 months
How highly positive response to test block influences 50% pain relief after RF treatment
Time frame: 6 months
How moderately positive response to test block influences 50% pain relief after RF treatment
Time frame: 6 months
How catastrophizing influences neck function after RF treatment.
Time frame: 6 months
How catastrophizing influences pain relief after RF treatment.
Time frame: 6 months
Change in mental distress after RF neurotomy vs sham treatment.
Time frame: 6 months
Change in mental distress after RF neurotomy vs sham treatment.
Time frame: 12 months
Change in sleep disturbances after RF neurotomy vs sham treatment.
Time frame: 6 months
Change in sleep disturbances after RF neurotomy vs sham treatment.
Time frame: 12 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Dec 2023.
- Individual participant dataSharing planned: Yes. Individual Participant Data Sharing Plan. In accordance with the general data sharing policy at OUH, the deidentified, individual data can be made available for external researchers from 9 months to 5 years after publication. However, to get access the researchers need to provide a methodologically sound proposal in accordance with the institutional guidelines and sign a data access agreement.
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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.
Gunnvald Kvarstein, Dr. Med principal investigator
Oslo University 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 Radiofrequency neurotomy in people with Neck Pain, run by Oslo University Hospital at 2 sites in Norway.
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 6 inclusion and 13 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 11 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 2 sites in Norway. 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. Some participants in this study may receive a placebo. 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 Gunnvald Kvarstein, Dr. Med (+47 92295309, gunnvald.kvarstein@uit.no), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in neck function after RF neurotomy vs sham treatment (time frame: 6 months). The study lists 2 primary outcomes in all. 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 11 Dec 2023.