Contained Cervical Disc HerniationNCT01797172
Is Treatment of the Intervertebral Disc More Effective at Short-term Than the Nerve Root in Patients With a Neck Hernia?
A study testing Percutaneous Cervical Nucleoplasty and Pulsed Radio Frequency in people with Contained Cervical Disc Herniation, run by Willy Halim at 1 site in Netherlands.
Trial summary
Pain management in a neck hernia relies initially on rest, physiotherapy, and/or oral medications. Once these treatments have failed, different alternative procedures can be applied to relief pain. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Contained Cervical Disc Herniation
- What is being tested?
- Percutaneous Cervical Nucleoplasty and Pulsed Radio Frequency
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 38 participants
- Where
- 1 siteNetherlands
- Study dates
- Oct 2012to Jul 2014
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients are legally competent and able to understand the nature, scope and aim of the clinical investigation and have given written informed consent to participate;
- Patients of either sex and of all races have been diagnosed with radiographically confirmed contained cervical disc herniation on MRI at one level;
- Patients received a diagnostic block;
- Patients failed conservative therapy during at least six weeks;
- Patients have complaints of radicular pain with or without neck pain, corresponding the herniated level;
- Patients score >=50 mm on 100 mm Visual Analogue Scale for pain (VAS-100 mm);
- Patients are able and willing to return for follow-up evaluations;
- Patients have a stable drug regime.
Who cannot join
- Patients have contraindications for intervention with PCN or PRF;
- Patients have been diagnosed with an extruded or sequestered disc fragment, spondylolisthesis, vertebral fracture or spinal stenosis;
- Patients have been diagnosed with uncovertebral or facet arthrosis;
- Patients underwent previous surgery or received any type of infiltrations at the indicated cervical level;
- Patients diagnosed with a contained cervical disc herniation >1/3 spinal canal;
- Patients with radiographically confirmed loss of >30% of disc height compared to adjacent level;
Show all 9Show fewer
- Patients with evidence of severe disc degeneration;
- Patients suffer from uncontrolled psychological disorders;
- Patients suffer from unstable medical condition.
Trial locations and contacts
1 site in 1 country.
Netherlands1 site, 1 recruiting
- Recruiting
Department of Anesthesia and Pain Management; St. Anna Hospital
Geldrop, North Brabant, 5664 EH
Willy Halim, MD, FIPP
Jorgen Wullems, MSc
About this study
Official title: Percutaneous Cervical Nucleoplasty vs. Pulsed Radio Frequency in Patients With Contained Cervical Disc Herniation; a Double-blind Randomized Clinical Trial
Pain management in a neck hernia relies initially on rest, physiotherapy, and/or oral medications. Once these treatments have failed, different alternative procedures can be applied to relief pain. Thermal treatment of the intervertebral disc (Percutaneous Cervical Nucleoplasty; PCN) is the most often applied technique on the neck with a low risk of thermal damage. A variety of published studies have demonstrated this treatment to be both safe and effective. However, treatment of the nerve root (Pulsed Radio Frequency; PRF) is also a popular type of pain treatment. The application of PRF is also a safe and useful intervention for neck pain. Although these treatment types are described in the literature, the available evidence for efficacy is not sufficient to allow definitive conclusions on the optimal therapy to be made. The purpose of this study is to investigate which technique is the most effective in terms of pain relief on short term in patients with contained cervical disc herniation: PCN or PRF?
- Conditions
- Contained Cervical Disc Herniation
- Being tested
- Percutaneous Cervical Nucleoplasty, Pulsed Radio Frequency
- Keywords
- nucleoplasty, pulsed radio frequency, herniated disc, cervical, percutaneous disc decompression, cervical radiculopathy
- Medical subject headings
- Intervertebral Disc Displacement, Radiculopathy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Percutaneous Cervical NucleoplastyProcedure or surgery
Also called CoBlation technology, ArthroCare
Cervical nucleoplasty is a method of percutaneous disc decompression using a 19 Gauge Trocar 3 inch spine needle (ArthroCare Co., Sunnyvale, CA, USA) which is brought to the annulus fibrosis of the herniated disc. If in the correct position, the stylet is withdrawn and the Perc DC SpineWand (ArthroCare Co., Sunnyvale, CA, USA) is introduced. The procedure relies on so-called Coblation technology which involves removing a portion of the nucleus tissue by using radio frequency energy. More specific, it results in ablation of a portion of nucleus tissue, not with heat, but with a low-temperature (typically 40-70° C) plasma field of ionized particles.
Pulsed Radio FrequencyProcedure or surgery
Pulsed Radio Frequency involves placement of a needle close to the to-be-treated nerve or dorsal root ganglion (DRG). The position is checked radiographically and by motor and sensory nerve stimulation. When the needle has been placed correctly an electrode is introduced, which conducts short bursts of radio frequency energy to nervous tissue. It is known as a non- or minimally neurodestructive technique, alternative to radio frequency heat lesions using so-called thermocoagulation. No nerve damage takes places as the temperature of the tip of the needle does not exceed 42°C. This is achieved by relatively long pauses between pulses which allow generated heat to dissipate and prevent the development of any thermal lesion.
| Study group | Role | What they receive |
|---|---|---|
| Percutaneous Cervical Nucleoplasty | Experimental | Percutaneous Cervical Nucleoplasty Receives: Procedure: Percutaneous Cervical Nucleoplasty |
| Pulsed Radio Frequency | Active comparator | Pulsed Radio Frequency treatment Receives: Procedure: Pulsed Radio Frequency |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in pain scores using a VAS-100 mm and VRS-5
The main study parameter to measure efficacy of the treatments is pain. Pain is measured using a VAS-100 mm and a Verbal Rating Scale using 5 categories (VRS-5). The investigator will ask the patient to mark the score for contemporary neck pain and/or radicular pain using both scales. Successful treatment is in most cases defined as a reduction in pain of >=50% using the VAS-100 mm at the final follow-up compared to the pre-operative score.
Measured: pre-operative, 1 month post-op, 2 months post-op and 3 months post-op
Secondary outcomes (8)
Change in general health status using the Short Form 12-item questionnaire (SF-12)
The Short Form 12-item questionnaire for general health (SF-12). The SF-12 is a self-administered survey that is used to monitor overall physical and mental health outcomes, and accounts as a practical alternative to the SF-36. The SF-12 has good retest reliability.
Measured: pre-operative, 1 month post-op, 2 months post-op and 3 months post-op
Change in neck functioning during activities of daily living using the Neck Disability Index (NDI)
The NDI is a disease-specific instrument that is used to assess the impact of spinal disorders on ten aspects of daily living. The NDI has excellent retest reliability (Pearson r > 0.80) and validity (moderately high correlations with the McGill Pain Questionnaire and VAS for pain).
Measured: pre-operative, 1 month post-op, 2 months post-op and 3 months post-op
Change in chronic pain experience using the Multidimensional Pain Inventory - Dutch Language Version (MPI-DLV)
The Multidimensional Pain Inventory - Dutch Language Version (MPI-DLV) for assessing a number of dimensions of chronic pain experience, including pain intensity, emotional distress, cognitive and functional adaptation, and social support. The MPI-DLV has good to excellent retest reliability.
Measured: pre-operative, 1 month post-op, 2 months post-op and 3 months post-op
Change in limitations in sports and work using multiple choice questions
Changes in limitations in sports and work are assessed using multiple choice questions. This also enables calculation of return to work-rate.
Measured: pre-operative, 1 month post-op, 2 months post-op and 3 months post-op
Occurence of (serious) adverse events ((S)AEs) post-operatively
Recording of (serious) adverse events ((S)AEs) to investigate the safety of both treatments, focusing on the number and percentage of (S)AEs. Also the intensity of treatment related adverse events will be reported:
- Mild: Discomfort noted, but no disruption to normal daily activities. Symptomatic treatment may have been given.
- Moderate: Moderate symptoms, moderate interference with the patient"s daily activities. Symptomatic treatment may have been given.
- Severe: Considerable interference with normal daily activities of the patient, unacceptable.
Measured: 1 month post-op, 2 months post-op and 3 months post-op
Cost-effectiveness evaluation of both treatments using patient's study diary
Patient's study diary for cost-effectiveness evaluation of both treatments. The use of (escape) medication and physician visit(s) will be reported during the three month follow-up period. The total costs per patient will be combined with their final treatment result (successful treatment, yes or no >=50% reduction on VAS-100 mm?) and analyzed per treatment group.
Measured: 3 months post-op
Change in pain medication usage
Recording of pain medication to assess the change in patient's drug regime before and after treatment.
Measured: pre-operative, 1 month post-op, 2 months post-op and 3 months post-op
Post-operative change in patient's treatment satisfaction using a dichotomous question and VAS-100 mm
Patient satisfaction with treatment (result) measured dichotomously via a question and continuously via VAS-100 mm.
Measured: 1 month post-op, 2 months post-op and 3 months post-op
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Feb 2013 (estimated)
- Study startOct 2012
- Primary completionJul 2014 (estimated)
- Study completionJul 2014 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Contained Cervical Disc HerniationStudies 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
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 38 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Willy Halim
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Willy Halim, St. Anna Ziekenhuis, Geldrop, Netherlands
- Investigators
- Willy Halim, MD, FIPP, Principal investigator, Department of Anesthesia and Pain Management, St. Anna Hospital, Geldrop, The Netherlands
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01797172
- Sponsor's protocol ID
- NL39783.015.12
- Status last verified
- Feb 2013
- First submitted
- 18 Feb 2013
- Last updated
- 22 Feb 2013
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 22 Feb 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Percutaneous Cervical Nucleoplasty vs. Pulsed Radio Frequency in Patients With Contained Cervical Disc Herniation; a Double-blind Randomized Clinical Trial
- ClinicalTrials.gov ID
- NCT01797172
- Acronym / sponsor ID
- NL39783.015.12
- Conditions
- Contained Cervical Disc Herniation
- Keywords
- nucleoplasty, pulsed radio frequency, herniated disc, cervical, percutaneous disc decompression, cervical radiculopathy
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 38 participants (estimated)
- Lead sponsor
- Willy HalimUniversity, hospital or other
- Study start
- Oct 2012
- Primary completion
- Jul 2014 (estimated)
- Study completion
- Jul 2014 (estimated)
- First posted
- 22 Feb 2013 (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.
Pain management in a neck hernia relies initially on rest, physiotherapy, and/or oral medications. Once these treatments have failed, different alternative procedures can be applied to relief pain. Thermal treatment of the intervertebral disc (Percutaneous Cervical Nucleoplasty; PCN) is the most often applied technique on the neck with a low risk of thermal damage. A variety of published studies have demonstrated this treatment to be both safe and effective. However, treatment of the nerve root (Pulsed Radio Frequency; PRF) is also a popular type of pain treatment. The application of PRF is also a safe and useful intervention for neck pain. Although these treatment types are described in the literature, the available evidence for efficacy is not sufficient to allow definitive conclusions on the optimal therapy to be made. The purpose of this study is to investigate which technique is the most effective in terms of pain relief on short term in patients with contained cervical disc herniation: PCN or PRF?
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Percutaneous Cervical Nucleoplasty | Experimental | Procedure: Percutaneous Cervical NucleoplastyPercutaneous Cervical Nucleoplasty |
| Pulsed Radio Frequency | Active comparator | Procedure: Pulsed Radio FrequencyPulsed Radio Frequency treatment |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- Patients are legally competent and able to understand the nature, scope and aim of the clinical investigation and have given written informed consent to participate;
- Patients of either sex and of all races have been diagnosed with radiographically confirmed contained cervical disc herniation on MRI at one level;
- Patients received a diagnostic block;
- Patients failed conservative therapy during at least six weeks;
- Patients have complaints of radicular pain with or without neck pain, corresponding the herniated level;
Key exclusion criteria (9 listed)
- Patients have contraindications for intervention with PCN or PRF;
- Patients have been diagnosed with an extruded or sequestered disc fragment, spondylolisthesis, vertebral fracture or spinal stenosis;
- Patients have been diagnosed with uncovertebral or facet arthrosis;
- Patients underwent previous surgery or received any type of infiltrations at the indicated cervical level;
- Patients diagnosed with a contained cervical disc herniation >1/3 spinal canal;
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 |
|---|---|---|
| Percutaneous Cervical NucleoplastyAlso: CoBlation technology, ArthroCareCervical nucleoplasty is a method of percutaneous disc decompression using a 19 Gauge Trocar 3 inch spine needle (ArthroCare Co., Sunnyvale, CA, USA) which is brought to the annulus fibrosis of the herniated disc. If in the correct position, the stylet is withdrawn and the Perc DC SpineWand (ArthroCare Co., Sunnyvale, CA, USA) is introduced. The procedure relies on so-called Coblation technology which involves removing a portion of the nucleus tissue by using radio frequency energy. More specific, it results in ablation of a portion of nucleus tissue, not with heat, but with a low-temperature (typically 40-70° C) plasma field of ionized particles. | Procedure or surgery | Percutaneous Cervical Nucleoplasty |
| Pulsed Radio FrequencyPulsed Radio Frequency involves placement of a needle close to the to-be-treated nerve or dorsal root ganglion (DRG). The position is checked radiographically and by motor and sensory nerve stimulation. When the needle has been placed correctly an electrode is introduced, which conducts short bursts of radio frequency energy to nervous tissue. It is known as a non- or minimally neurodestructive technique, alternative to radio frequency heat lesions using so-called thermocoagulation. No nerve damage takes places as the temperature of the tip of the needle does not exceed 42°C. This is achieved by relatively long pauses between pulses which allow generated heat to dissipate and prevent the development of any thermal lesion. | Procedure or surgery | Pulsed Radio Frequency |
Primary outcome
Change in pain scores using a VAS-100 mm and VRS-5
Time frame: pre-operative, 1 month post-op, 2 months post-op and 3 months post-op
The main study parameter to measure efficacy of the treatments is pain. Pain is measured using a VAS-100 mm and a Verbal Rating Scale using 5 categories (VRS-5). The investigator will ask the patient to mark the score for contemporary neck pain and/or radicular pain using both scales. Successful treatment is in most cases defined as a reduction in pain of >=50% using the VAS-100 mm at the final follow-up compared to the pre-operative score.
8 secondary outcomes
Change in general health status using the Short Form 12-item questionnaire (SF-12)
Time frame: pre-operative, 1 month post-op, 2 months post-op and 3 months post-op
Change in neck functioning during activities of daily living using the Neck Disability Index (NDI)
Time frame: pre-operative, 1 month post-op, 2 months post-op and 3 months post-op
Change in chronic pain experience using the Multidimensional Pain Inventory - Dutch Language Version (MPI-DLV)
Time frame: pre-operative, 1 month post-op, 2 months post-op and 3 months post-op
Change in limitations in sports and work using multiple choice questions
Time frame: pre-operative, 1 month post-op, 2 months post-op and 3 months post-op
Occurence of (serious) adverse events ((S)AEs) post-operatively
Time frame: 1 month post-op, 2 months post-op and 3 months post-op
Cost-effectiveness evaluation of both treatments using patient's study diary
Time frame: 3 months post-op
Change in pain medication usage
Time frame: pre-operative, 1 month post-op, 2 months post-op and 3 months post-op
Post-operative change in patient's treatment satisfaction using a dichotomous question and VAS-100 mm
Time frame: 1 month post-op, 2 months post-op and 3 months post-op
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Feb 2013.
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.
Willy Halim, MD, FIPP principal investigator
Department of Anesthesia and Pain Management, St. Anna Hospital, Geldrop, The Netherlands
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Percutaneous Cervical Nucleoplasty and Pulsed Radio Frequency in people with Contained Cervical Disc Herniation, run by Willy Halim 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 8 inclusion and 9 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 22 Feb 2013. 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 Jorgen Wullems, MSc (0031402864524, j.wullems@st-anna.nl), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in pain scores using a VAS-100 mm and VRS-5 (time frame: pre-operative, 1 month post-op, 2 months post-op and 3 months post-op). 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 Feb 2013.