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 Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Enrollment
38
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 If in the correct position, the stylet is withdrawn and the Perc DC SpineWand (ArthroCare Co., Sunnyvale, CA, USA) is introduced.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 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.
Department of Anesthesia and Pain Management; St. Anna Hospital
Geldrop, North Brabant, Netherlands
RECRUITINGChange 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.
Time frame: pre-operative, 1 month post-op, 2 months post-op and 3 months post-op
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.
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)
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
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.
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
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
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.
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
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
Change in pain medication usage
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
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.
Time frame: 1 month post-op, 2 months post-op and 3 months post-op
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