Neck PainNCT00476684
The Effect of Radiofrequency-treatment on Patients With Facet-joint Pain in Cervical- and Lumbar-columna
A study testing radiofrequency treatment in people with Neck Pain and Low Back Pain, run by Norwegian University of Science and Technology at 1 site in Norway.
Trial summary
There is conflicting evidence on whether radio-frequency neurotomy of the medial branch has a significant effect on pain in patients with chronic unilateral facet joint neck and back pain. Read more about this study
- Who is it for?
- Ages 20 to 75 years
- Conditions the study is for
- Neck Pain, Low Back Pain
- What is being tested?
- radiofrequency treatment
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 28 participants
- Where
- 1 siteNorway
- Study dates
- Aug 2004to May 2011
- 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 20 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- one-sided neck and low back chronic pain
- pain durability of at least 1 year
Who cannot join
- other somatic or psychiatric disorders
- pregnancy
- stated co-morbidity
- anaesthetics intolerance
- no effect of diagnostic blockades (one or two)
Trial locations and contacts
1 site in 1 country.
About this study
There is conflicting evidence on whether radio-frequency neurotomy of the medial branch has a significant effect on pain in patients with chronic unilateral facet joint neck and back pain.
We will evaluate radiofrequency treatment on medial-branch of the ramus dorsalis as an effective pain treatment for patients with chronic pain originated from facet-joints in cervical and lumbar columna.
- Conditions
- Neck Pain, Low Back Pain
- Being tested
- radiofrequency treatment, sham neurotomy
- Keywords
- radiofrequency
- Medical subject headings
- Neck Pain, Low Back Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
radiofrequency treatmentProcedure or surgery
Radiofrequency-neurotomy of the medial branch at 80 degr. C needle temperature for 70 seconds, after diagnostic blocks
sham neurotomyProcedure or surgery
Radiofrequency-neurotomy of the medial branch at 37 degr. C needle temperature for 70 seconds, after diagnostic blocks
| Study group | Role | What they receive |
|---|---|---|
| radiofrequency neurotomy | Experimental | Radiofrequency-neurotomy of the medial branch at 80 degr. C for 70 seconds, after diagnostic blocks Receives: Procedure: radiofrequency treatment |
| sham controls | Sham comparator | Radiofrequency-neurotomy of the medial branch at 37 degr. C needle temperature for 70 seconds, after diagnostic blocks Receives: Procedure: sham neurotomy |
What is being measured
The primary outcome is the main question the study is designed to answer.
reduction in self-reported pain intensity
Numerig rating scale 1 to 10
Measured: up to 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 May 2007 (estimated)
- Study startAug 2004
- Primary completionMay 2010
- Study completionMay 2011
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 Norwegian University of Science and TechnologyThe 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
- Factorial
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 28 participants (actual)
Sponsor and investigators
- Lead sponsor
- Norwegian University of Science and Technology
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Petter C. Borchgrevink, prof. PhD MD, Principal investigator, Norwegian University of Science and TechnologyTarjei Rygnestad, Prof. PhD MD, Study director, Norwegian University of Science and Technology
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00476684
- Sponsor's protocol ID
- 023-04REK
- Status last verified
- Aug 2017
- First submitted
- 21 May 2007
- Last updated
- 22 Aug 2017
- 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 Aug 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Radiofrequency-treatment on Patients With Facet-joint Pain in Cervical- and Lumbar-columna
- ClinicalTrials.gov ID
- NCT00476684
- Acronym / sponsor ID
- 023-04REK
- Conditions
- Neck Pain, Low Back Pain
- Keywords
- radiofrequency
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 28 participants (actual)
- Lead sponsor
- Norwegian University of Science and TechnologyUniversity, hospital or other
- Study start
- Aug 2004 (actual)
- Primary completion
- May 2010 (actual)
- Study completion
- May 2011 (actual)
- First posted
- 22 May 2007 (estimated)
- 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.
There is conflicting evidence on whether radio-frequency neurotomy of the medial branch has a significant effect on pain in patients with chronic unilateral facet joint neck and back pain.
We will evaluate radiofrequency treatment on medial-branch of the ramus dorsalis as an effective pain treatment for patients with chronic pain originated from facet-joints in cervical and lumbar columna.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Factorial
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| radiofrequency neurotomy | Experimental | Procedure: radiofrequency treatmentRadiofrequency-neurotomy of the medial branch at 80 degr. C for 70 seconds, after diagnostic blocks |
| sham controls | Sham comparator | Procedure: sham neurotomyRadiofrequency-neurotomy of the medial branch at 37 degr. C needle temperature for 70 seconds, after diagnostic blocks |
Who may qualify
- Ages
- 20 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- one-sided neck and low back chronic pain
- pain durability of at least 1 year
Key exclusion criteria (5 listed)
- other somatic or psychiatric disorders
- pregnancy
- stated co-morbidity
- anaesthetics intolerance
- no effect of diagnostic blockades (one or two)
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 treatmentRadiofrequency-neurotomy of the medial branch at 80 degr. C needle temperature for 70 seconds, after diagnostic blocks | Procedure or surgery | radiofrequency neurotomy |
| sham neurotomyRadiofrequency-neurotomy of the medial branch at 37 degr. C needle temperature for 70 seconds, after diagnostic blocks | Procedure or surgery | sham controls |
Primary outcome
reduction in self-reported pain intensity
Time frame: up to 1 year
Numerig rating scale 1 to 10
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 22 Aug 2017.
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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.
Petter C. Borchgrevink, prof. PhD MD principal investigator
Norwegian University of Science and Technology
Tarjei Rygnestad, Prof. PhD MD study director
Norwegian University of Science and Technology
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing radiofrequency treatment in people with Neck Pain and Low Back Pain, run by Norwegian University of Science and Technology at 1 site 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 2 inclusion and 5 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 22 Aug 2017. 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 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?
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?
reduction in self-reported pain intensity (time frame: up to 1 year). 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 Aug 2017.