Back to resultsIs Treatment of the Intervertebral Disc More Effective at Short-term Than the Nerve Root in Patients With a Neck Hernia?
Primary Purpose
Contained Cervical Disc Herniation
Status
Unknown status
Phase
Not Applicable
Locations
Netherlands
Study Type
Interventional
Intervention
Percutaneous Cervical Nucleoplasty
Pulsed Radio Frequency
Sponsored by
About this trial
This is an interventional treatment trial for Contained Cervical Disc Herniation focused on measuring nucleoplasty, pulsed radio frequency, herniated disc, cervical, percutaneous disc decompression, cervical radiculopathy
Eligibility Criteria
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.
Sites / Locations
- Department of Anesthesia and Pain Management; St. Anna HospitalRecruiting
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
Percutaneous Cervical Nucleoplasty
Pulsed Radio Frequency
Arm Description
Percutaneous Cervical Nucleoplasty
Pulsed Radio Frequency treatment
Outcomes
Primary Outcome Measures
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.
Secondary Outcome Measures
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.
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).
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.
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.
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.
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.
Change in pain medication usage
Recording of pain medication to assess the change in patient's drug regime before and after treatment.
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.
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT01797172
Brief Title
Is Treatment of the Intervertebral Disc More Effective at Short-term Than the Nerve Root in Patients With a Neck Hernia?
Official Title
Percutaneous Cervical Nucleoplasty vs. Pulsed Radio Frequency in Patients With Contained Cervical Disc Herniation; a Double-blind Randomized Clinical Trial
Study Type
Interventional
2. Study Status
Record Verification Date
February 2013
Overall Recruitment Status
Unknown status
Study Start Date
October 2012 (undefined)
Primary Completion Date
July 2014 (Anticipated)
Study Completion Date
July 2014 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor-Investigator
Name of the Sponsor
Willy Halim
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief 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. 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?
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Contained Cervical Disc Herniation
Keywords
nucleoplasty, pulsed radio frequency, herniated disc, cervical, percutaneous disc decompression, cervical radiculopathy
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantOutcomes Assessor
Allocation
Randomized
Enrollment
38 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Percutaneous Cervical Nucleoplasty
Arm Type
Experimental
Arm Description
Percutaneous Cervical Nucleoplasty
Arm Title
Pulsed Radio Frequency
Arm Type
Active Comparator
Arm Description
Pulsed Radio Frequency treatment
Intervention Type
Procedure
Intervention Name(s)
Percutaneous Cervical Nucleoplasty
Other Intervention Name(s)
CoBlation technology, ArthroCare
Intervention Description
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.
Intervention Type
Procedure
Intervention Name(s)
Pulsed Radio Frequency
Intervention Description
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.
Primary Outcome Measure Information:
Title
Change in pain scores using a VAS-100 mm and VRS-5
Description
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.
Time Frame
pre-operative, 1 month post-op, 2 months post-op and 3 months post-op
Secondary Outcome Measure Information:
Title
Change in general health status using the Short Form 12-item questionnaire (SF-12)
Description
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.
Time Frame
pre-operative, 1 month post-op, 2 months post-op and 3 months post-op
Title
Change in neck functioning during activities of daily living using the Neck Disability Index (NDI)
Description
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).
Time Frame
pre-operative, 1 month post-op, 2 months post-op and 3 months post-op
Title
Change in chronic pain experience using the Multidimensional Pain Inventory - Dutch Language Version (MPI-DLV)
Description
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.
Time Frame
pre-operative, 1 month post-op, 2 months post-op and 3 months post-op
Title
Change in limitations in sports and work using multiple choice questions
Description
Changes in limitations in sports and work are assessed using multiple choice questions. This also enables calculation of return to work-rate.
Time Frame
pre-operative, 1 month post-op, 2 months post-op and 3 months post-op
Title
Occurence of (serious) adverse events ((S)AEs) post-operatively
Description
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.
Time Frame
1 month post-op, 2 months post-op and 3 months post-op
Title
Cost-effectiveness evaluation of both treatments using patient's study diary
Description
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.
Time Frame
3 months post-op
Title
Change in pain medication usage
Description
Recording of pain medication to assess the change in patient's drug regime before and after treatment.
Time Frame
pre-operative, 1 month post-op, 2 months post-op and 3 months post-op
Title
Post-operative change in patient's treatment satisfaction using a dichotomous question and VAS-100 mm
Description
Patient satisfaction with treatment (result) measured dichotomously via a question and continuously via VAS-100 mm.
Time Frame
1 month post-op, 2 months post-op and 3 months post-op
Other Pre-specified Outcome Measures:
Title
Confounding baseline parameters
Description
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.
Time Frame
pre-operative
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Jorgen Wullems, MSc
Phone
0031402864524
Email
j.wullems@st-anna.nl
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Willy Halim, MD, FIPP
Organizational Affiliation
Department of Anesthesia and Pain Management, St. Anna Hospital, Geldrop, The Netherlands
Official's Role
Principal Investigator
Facility Information:
Facility Name
Department of Anesthesia and Pain Management; St. Anna Hospital
City
Geldrop
State/Province
Noord-Brabant
ZIP/Postal Code
5664 EH
Country
Netherlands
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Willy Halim, MD, FIPP
First Name & Middle Initial & Last Name & Degree
Jorgen Wullems, MSc
12. IPD Sharing Statement
Learn more about this trial
Is Treatment of the Intervertebral Disc More Effective at Short-term Than the Nerve Root in Patients With a Neck Hernia?
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