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

Status

Indicates the current recruitment status or the expanded access status.
Unknown

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Anticipated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
38

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • 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

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Locations

  • Netherlands
    • Noord-Brabant
      • Geldrop, Noord-Brabant, Netherlands, 5664 EH
        • Recruiting
        • Department of Anesthesia and Pain Management; St. Anna Hospital
        • Principal Investigator:
          • Willy Halim, MD, FIPP
        • 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

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

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

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
EXPERIMENTAL: Percutaneous Cervical Nucleoplasty
Procedure: 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:
  • CoBlation technology
  • ArthroCare
ACTIVE_COMPARATOR: Pulsed Radio Frequency
Pulsed Radio Frequency treatment
Procedure: Pulsed Radio Frequency
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.

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
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.
pre-operative, 1 month post-op, 2 months post-op and 3 months post-op

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
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
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).
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
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.
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

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.
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
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.
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
Recording of pain medication to assess the change in patient's drug regime before and after treatment.
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
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

Other Outcome Measures

Other Outcome Measures

For clinical trials, a planned measurement described in the protocol that is used to determine the effect of an intervention/treatment on participants. For observational studies, a measurement or observation that is used to describe patterns of diseases or traits, or associations with exposures, risk factors, or treatment. Types of outcome measures include primary outcome measure and secondary outcome measure.
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.
pre-operative

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Willy Halim

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • 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

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
October 1, 2012

Primary Completion (ANTICIPATED)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
July 1, 2014

Study Completion (ANTICIPATED)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
July 1, 2014

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
February 18, 2013

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
February 20, 2013

First Posted (ESTIMATE)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
February 22, 2013

Study Record Updates

Last Update Posted (ESTIMATE)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
February 22, 2013

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
February 20, 2013

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
February 1, 2013

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant 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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