Is Treatment of the Intervertebral Disc More Effective at Short-term Than the Nerve Root in Patients With a Neck Hernia?
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT01797172|
Recruitment Status : Unknown
Verified February 2013 by Willy Halim, St. Anna Ziekenhuis, Geldrop, Netherlands.
Recruitment status was: Recruiting
First Posted : February 22, 2013
Last Update Posted : February 22, 2013
|Condition or disease||Intervention/treatment||Phase|
|Contained Cervical Disc Herniation||Procedure: Percutaneous Cervical Nucleoplasty Procedure: Pulsed Radio Frequency||Not Applicable|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||38 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Double (Participant, Outcomes Assessor)|
|Official Title:||Percutaneous Cervical Nucleoplasty vs. Pulsed Radio Frequency in Patients With Contained Cervical Disc Herniation; a Double-blind Randomized Clinical Trial|
|Study Start Date :||October 2012|
|Estimated Primary Completion Date :||July 2014|
|Estimated Study Completion Date :||July 2014|
Experimental: Percutaneous Cervical Nucleoplasty
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 If in the correct position, the stylet is withdrawn and the Perc DC SpineWand (ArthroCare Co., Sunnyvale, CA, USA) is introduced.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.
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.
- 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.
- 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.
- 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).
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01797172
|Contact: Jorgen Wullems, MScemail@example.com|
|Department of Anesthesia and Pain Management; St. Anna Hospital||Recruiting|
|Geldrop, Noord-Brabant, Netherlands, 5664 EH|
|Principal Investigator: Willy Halim, MD, FIPP|
|Sub-Investigator: Jorgen Wullems, MSc|
|Principal Investigator:||Willy Halim, MD, FIPP||Department of Anesthesia and Pain Management, St. Anna Hospital, Geldrop, The Netherlands|