Facet Joint ArthritisNCT01743326
RFD Versus Cervical Medial Branch Blocks in Chronic Degenerative Neck Pain
A study testing Radio Frequency Denervation and Local Anesthesia in people with Facet Joint Arthritis and Pain, run by Maastricht University Medical Center at 1 site in Netherlands.
Trial summary
Rationale: the facet joints are an important pain generator in chronic neck pain. The beneficial effect of radio frequency treatment (RFD) of the cervical facet joints has been described in a Randomized Clinical Trial (RCT) in patients with Whiplash Associated Disorders. Read more about this study
- Who is it for?
- Ages 25 to 90 years
- Conditions the study is for
- Facet Joint Arthritis, Pain, Radiofrequency Denervation
- What is being tested?
- Radio Frequency Denervation and Local Anesthesia
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 84 participants
- Where
- 1 siteNetherlands
- Study dates
- Nov 2012to Jun 2015
- 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 25 to 90 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patient's age > 25 year
- Signs of degeneration on lateral X-ray
- Cervical facets to be treated between C2 and C7
- Pain for at least 3 months and conservative treatment medication (=paracetamol, Non-Steroidal anti-inflammatory Drugs (NSAID) and/or physical therapy) prior to referral to the pain clinic
- Neck pain on a Numeric Rating Scale ≥ 5
Who cannot join
- Radiation beyond the shoulder/radicular pain
- Shoulder pain/pathology
- The complaints are directly related to traumatic event e.g. Whiplash (WAD)
- Patient is pregnant, or pregnancy is suspected
- Patient has a cardiac pacemaker, automatic defibrillator or any leads in the neck area
- Allergy to contrast media or drugs to be used in the procedure
Show all 12Show fewer
- History of anterior fusion at the cervical level to be treated
- Patient is simultaneously participating in another device or drug study related to cervical pain.
- Patient has a spinal fracture, tumor or infection.
- Patient has a central cord lesion in the cervical spine
- Neurologic deficit
- Evidence of disc herniation (extruded, sequestered on MRI imaging)
Trial locations and contacts
1 site in 1 country.
Netherlands1 site, 1 recruiting
- Recruiting
Maastricht University Medical Center
Maastricht, Limburg
Maarten van Eerd, MD, +31 43 3875606, mveerd@gmail.com
Nelleke de Meij, MSc, +31 43 3872335, p.de.meij@mumc.nl
About this study
Official title: Percutaneous Radiofrequency Denervation of the Cervical Facet Joints Compared With Cervical Medial Branch Block of the Facet Joints for Patients With Chronic Degenerative Neck Pain : A Prospective Randomized Clinical Study
Rationale: the facet joints are an important pain generator in chronic neck pain. The beneficial effect of radio frequency treatment (RFD) of the cervical facet joints has been described in a Randomized Clinical Trial (RCT) in patients with Whiplash Associated Disorders. In patients with degenerative neck complaints a positive effect has been described in observational studies. Given this positive effect performing a RCT of RFD in this patient population is indicated.
Objective: to evaluate the effect of Radio Frequency treatment in patients with chronic degenerative neck pain.
Read more
Study design: prospective, randomized, double blinded clinical trial. Study population: patients older than 25 years, referred to the University Pain Center of Maastricht and the Pain Center of Amphia hospital Breda, with chronic axial neck pain.
Intervention: patients with at least 3 months of neck pain without radiation to the arm (only radiation beyond the shoulder) will be randomized in 2 groups. The first group (RFD + local anesthesia-group=intervention group) will receive RF treatment adjacent to the medial branch innervating the cervical facet joints after the application of bupivacaine 0.5 ml (0.25%). The second group (local anesthesia-group=control group) will only receive the application of 0.5 ml bupivacaine (0.25%) adjacent to the medial branch. The only difference between the two groups is the RF-denervation of the medial branches.
Main study parameters/endpoints: the primary research question is to evaluate the extent of pain reduction induced by RF treatment (RFD + local anesthesia-group=intervention group) compared with the local anesthesia-group(control group.
Following evaluation tools are used : Numeric Rating Scale (NRS), Patient global Impression of Change on a 7 point Likert Scale (PGIC), consumption of pain medication (MQS), Patient Specific Functional Scale, Quality of life scale (RAND 36), Hospital Anxiety and Depression scale (HADS), and Neck Disability Index (NDI, Dutch version).
Nature and extent of the burden and risks associated with participation, benefit and group relatedness: Patients in the RFD + Local Anesthesia-group and Local Anesthesia-group will undergo a physical examination before and 6 weeks after the intervention, by an independent third party, this will be repeated at 3 and 6 months if abnormalities are observed. At each of these time points the patients will receive questionnaires to fill out. A puncture of a blood vessel is possible, diagnosed by injection of contrast, for which repositioning of the needle is needed. Should accidental intravascular injection of local anesthetic occur, the dose used is low and reports show that intravascular injection of bupivacaine 2,5 mg does not pose clinical problems. The dura can be punctured; as a consequence contrast will flow in the cerebrospinal fluid. The procedure will be stopped and repeated after a few days. In theory a lesion of the nerve root is possible, but the needles are designed to avoid this, this complication has not been seen since more than 10 years. Up till now, a transient pain is occasionally described after the RF treatment. No hypesthesia or motor complications were reported. Since the risks of RF treatment are reported low and more related to needle placement there is no difference in risk and burden between the two treatment groups.
- Conditions
- Facet Joint Arthritis, Pain, Radiofrequency Denervation
- Being tested
- Radio Frequency Denervation, Local Anesthesia
- Keywords
- Zygapophyseal Joint
- Medical subject headings
- Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Radio Frequency DenervationProcedure or surgery
Local AnesthesiaProcedure or surgery
| Study group | Role | What they receive |
|---|---|---|
| RFD-group | Experimental | Radio Frequency Denervation Receives: Procedure: Radio Frequency Denervation; Procedure: Local Anesthesia |
| Local Anesthesia-group | Active comparator | Local Anesthesia-group Receives: Procedure: Local Anesthesia |
What is being measured
The primary outcome is the main question the study is designed to answer.
Mean pain intensity measured on a 11-point Numeric Rating Scale (NRS).
Measured: Baseline, 6 months
Patient Global Impression of Change according to a 7-point Likert scale (PGIC).
Measured: Baseline, 6 months
Changes in use of pain medication according to the Medication Quantification Scale (MQS).
Measured: Baseline, 6 months
Changes in the Neck Disability Index scale (NDI).
Measured: Baseline, 6 months
Secondary outcomes (4)
Changes in quality of life and differences between groups by means of RAND 36.
Measured: Baseline, 6 months
Improvement in functionality measured by the Patient Specific Functional Scale.
Measured: Baseline, 6 months
Change in physical/neurological examination parameters.
Measured: Baseline, 6 months
Change in employment status.
Measured: Baseline, 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Dec 2012 (estimated)
- Study startNov 2012
- Primary completionJun 2015 (estimated)
- Study completionJun 2015 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Facet Joint ArthritisStudies of the same condition, open and under way.
- More trials run by Maastricht University Medical CenterThe 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
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 84 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Maastricht University Medical Center
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Maarten van Kleef, Prf. MD, Principal investigator, Maastricht University Medical Centre
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01743326
- Sponsor's protocol ID
- METC 12-2-031
- Status last verified
- Jan 2015
- First submitted
- 21 Nov 2012
- Last updated
- 16 Jan 2015
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 16 Jan 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Percutaneous Radiofrequency Denervation of the Cervical Facet Joints Compared With Cervical Medial Branch Block of the Facet Joints for Patients With Chronic Degenerative Neck Pain : A Prospective Randomized Clinical Study
- ClinicalTrials.gov ID
- NCT01743326
- Acronym / sponsor ID
- METC 12-2-031
- Conditions
- Facet Joint Arthritis, Pain, Radiofrequency Denervation
- Keywords
- Zygapophyseal Joint
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 84 participants (estimated)
- Lead sponsor
- Maastricht University Medical CenterUniversity, hospital or other
- Study start
- Nov 2012
- Primary completion
- Jun 2015 (estimated)
- Study completion
- Jun 2015 (estimated)
- First posted
- 6 Dec 2012 (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.
Rationale: the facet joints are an important pain generator in chronic neck pain. The beneficial effect of radio frequency treatment (RFD) of the cervical facet joints has been described in a Randomized Clinical Trial (RCT) in patients with Whiplash Associated Disorders. In patients with degenerative neck complaints a positive effect has been described in observational studies. Given this positive effect performing a RCT of RFD in this patient population is indicated.
Objective: to evaluate the effect of Radio Frequency treatment in patients with chronic degenerative neck pain.
Study design: prospective, randomized, double blinded clinical trial. Study population: patients older than 25 years, referred to the University Pain Center of Maastricht and the Pain Center of Amphia hospital Breda, with chronic axial neck pain.
Intervention: patients with at least 3 months of neck pain without radiation to the arm (only radiation beyond the shoulder) will be randomized in 2 groups. The first group (RFD + local anesthesia-group=intervention group) will receive RF treatment adjacent to the medial branch innervating the cervical facet joints after the application of bupivacaine 0.5 ml (0.25%). The second group (local anesthesia-group=control group) will only receive the application of 0.5 ml bupivacaine (0.25%) adjacent to the medial branch. The only difference between the two groups is the RF-denervation of the medial branches.
Main study parameters/endpoints: the primary research question is to evaluate the extent of pain reduction induced by RF treatment (RFD + local anesthesia-group=intervention group) compared with the local anesthesia-group(control group.
Following evaluation tools are used : Numeric Rating Scale (NRS), Patient global Impression of Change on a 7 point Likert Scale (PGIC), consumption of pain medication (MQS), Patient Specific Functional Scale, Quality of life scale (RAND 36), Hospital Anxiety and Depression scale (HADS), and Neck Disability Index (NDI, Dutch version).
Nature and extent of the burden and risks associated with participation, benefit and group relatedness: Patients in the RFD + Local Anesthesia-group and Local Anesthesia-group will undergo a physical examination before and 6 weeks after the intervention, by an independent third party, this will be repeated at 3 and 6 months if abnormalities are observed. At each of these time points the patients will receive questionnaires to fill out. A puncture of a blood vessel is possible, diagnosed by injection of contrast, for which repositioning of the needle is needed. Should accidental intravascular injection of local anesthetic occur, the dose used is low and reports show that intravascular injection of bupivacaine 2,5 mg does not pose clinical problems. The dura can be punctured; as a consequence contrast will flow in the cerebrospinal fluid. The procedure will be stopped and repeated after a few days. In theory a lesion of the nerve root is possible, but the needles are designed to avoid this, this complication has not been seen since more than 10 years. Up till now, a transient pain is occasionally described after the RF treatment. No hypesthesia or motor complications were reported. Since the risks of RF treatment are reported low and more related to needle placement there is no difference in risk and burden between the two treatment groups.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| RFD-group | Experimental | Procedure: Radio Frequency Denervation, Procedure: Local AnesthesiaRadio Frequency Denervation |
| Local Anesthesia-group | Active comparator | Procedure: Local AnesthesiaLocal Anesthesia-group |
Who may qualify
- Ages
- 25 to 90 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Patient's age > 25 year
- Signs of degeneration on lateral X-ray
- Cervical facets to be treated between C2 and C7
- Pain for at least 3 months and conservative treatment medication (=paracetamol, Non-Steroidal anti-inflammatory Drugs (NSAID) and/or physical therapy) prior to referral to the pain clinic
- Neck pain on a Numeric Rating Scale ≥ 5
Key exclusion criteria (12 listed)
- Radiation beyond the shoulder/radicular pain
- Shoulder pain/pathology
- The complaints are directly related to traumatic event e.g. Whiplash (WAD)
- Patient is pregnant, or pregnancy is suspected
- Patient has a cardiac pacemaker, automatic defibrillator or any leads in the neck area
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 |
|---|---|---|
| Radio Frequency Denervation | Procedure or surgery | RFD-group |
| Local Anesthesia | Procedure or surgery | Local Anesthesia-group, RFD-group |
Primary outcome
Mean pain intensity measured on a 11-point Numeric Rating Scale (NRS).
Time frame: Baseline, 6 months
Patient Global Impression of Change according to a 7-point Likert scale (PGIC).
Time frame: Baseline, 6 months
Changes in use of pain medication according to the Medication Quantification Scale (MQS).
Time frame: Baseline, 6 months
Changes in the Neck Disability Index scale (NDI).
Time frame: Baseline, 6 months
4 secondary outcomes
Changes in quality of life and differences between groups by means of RAND 36.
Time frame: Baseline, 6 months
Improvement in functionality measured by the Patient Specific Functional Scale.
Time frame: Baseline, 6 months
Change in physical/neurological examination parameters.
Time frame: Baseline, 6 months
Change in employment status.
Time frame: Baseline, 6 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Jan 2015.
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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.
Maarten van Kleef, Prf. MD principal investigator
Maastricht University Medical Centre
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Radio Frequency Denervation and Local Anesthesia in people with Facet Joint Arthritis and Pain, run by Maastricht University Medical Center at 1 site in Netherlands.
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 5 inclusion and 12 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 16 Jan 2015. 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 Netherlands. 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 Maarten van Eerd, MD (+31 43 3875606, mveerd@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Mean pain intensity measured on a 11-point Numeric Rating Scale (NRS). (time frame: Baseline, 6 months). The study lists 4 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 16 Jan 2015.