- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01797172
Is Treatment of the Intervertebral Disc More Effective at Short-term Than the Nerve Root in Patients With a Neck Hernia?
February 20, 2013 updated by: Willy Halim
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?
Study Overview
Status
Unknown
Conditions
Intervention / Treatment
Study Type
Interventional
Enrollment (Anticipated)
38
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Contact
- Name: Jorgen Wullems, MSc
- Phone Number: 0031402864524
- Email: j.wullems@st-anna.nl
Study Locations
-
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Noord-Brabant
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Geldrop, Noord-Brabant, Netherlands, 5664 EH
- Recruiting
- Department of Anesthesia and Pain Management; St. Anna Hospital
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Principal Investigator:
- Willy Halim, MD, FIPP
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Sub-Investigator:
- Jorgen Wullems, MSc
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years and older (ADULT, OLDER_ADULT)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
Inclusion Criteria:
- 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.
Exclusion Criteria:
- 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;
- Patients with evidence of severe disc degeneration;
- Patients suffer from uncontrolled psychological disorders;
- Patients suffer from unstable medical condition.
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: TREATMENT
- Allocation: RANDOMIZED
- Interventional Model: PARALLEL
- Masking: DOUBLE
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
EXPERIMENTAL: Percutaneous Cervical Nucleoplasty
|
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.
Other Names:
|
ACTIVE_COMPARATOR: Pulsed Radio Frequency
Pulsed Radio Frequency treatment
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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.
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
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.
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pre-operative, 1 month post-op, 2 months post-op and 3 months post-op
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
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
|
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.
|
pre-operative, 1 month post-op, 2 months post-op and 3 months post-op
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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
|
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).
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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
|
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.
|
pre-operative, 1 month post-op, 2 months post-op and 3 months post-op
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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
|
Changes in limitations in sports and work are assessed using multiple choice questions.
This also enables calculation of return to work-rate.
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pre-operative, 1 month post-op, 2 months post-op and 3 months post-op
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Occurence of (serious) adverse events ((S)AEs) post-operatively
Time Frame: 1 month post-op, 2 months post-op and 3 months post-op
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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:
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1 month post-op, 2 months post-op and 3 months post-op
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Cost-effectiveness evaluation of both treatments using patient's study diary
Time Frame: 3 months post-op
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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.
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3 months post-op
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Change in pain medication usage
Time Frame: pre-operative, 1 month post-op, 2 months post-op and 3 months post-op
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Recording of pain medication to assess the change in patient's drug regime before and after treatment.
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pre-operative, 1 month post-op, 2 months post-op and 3 months post-op
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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
|
Patient satisfaction with treatment (result) measured dichotomously via a question and continuously via VAS-100 mm.
|
1 month post-op, 2 months post-op and 3 months post-op
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Other Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Confounding baseline parameters
Time Frame: pre-operative
|
Confounding parameters will be documented before treatment and analyzed.
Documented will be age, gender, duration of symptoms, cervical level of contained disc herniation, previous treatment, concomitant therapy/medication, occupation, sports participation and hobbies.
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pre-operative
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Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Principal Investigator: Willy Halim, MD, FIPP, Department of Anesthesia and Pain Management, St. Anna Hospital, Geldrop, The Netherlands
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
October 1, 2012
Primary Completion (ANTICIPATED)
July 1, 2014
Study Completion (ANTICIPATED)
July 1, 2014
Study Registration Dates
First Submitted
February 18, 2013
First Submitted That Met QC Criteria
February 20, 2013
First Posted (ESTIMATE)
February 22, 2013
Study Record Updates
Last Update Posted (ESTIMATE)
February 22, 2013
Last Update Submitted That Met QC Criteria
February 20, 2013
Last Verified
February 1, 2013
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- NL39783.015.12
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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