Clinical trial NCT01797172: 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
Overall status: UNKNOWN
Phase: NA
Conditions: Contained Cervical Disc Herniation
Keywords: nucleoplasty
pulsed radio frequency
herniated disc
cervical
percutaneous disc decompression
cervical radiculopathy
Lead sponsor: St. Anna Ziekenhuis, Geldrop, Netherlands
Sponsor class: OTHER
First posted: 2013-02-22
Enrollment: 38
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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?


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.

Primary outcomes:
measure: Change in pain scores using a VAS-100 mm and VRS-5
timeFrame: pre-operative, 1 month post-op, 2 months post-op and 3 months post-op
Secondary outcomes:
measure: Change in general health status using the Short Form 12-item questionnaire (SF-12)
timeFrame: pre-operative, 1 month post-op, 2 months post-op and 3 months post-op
measure: Change in neck functioning during activities of daily living using the Neck Disability Index (NDI)
timeFrame: pre-operative, 1 month post-op, 2 months post-op and 3 months post-op
measure: Change in chronic pain experience using the Multidimensional Pain Inventory - Dutch Language Version (MPI-DLV)
timeFrame: pre-operative, 1 month post-op, 2 months post-op and 3 months post-op
measure: Change in limitations in sports and work using multiple choice questions
timeFrame: pre-operative, 1 month post-op, 2 months post-op and 3 months post-op
measure: Occurence of (serious) adverse events ((S)AEs) post-operatively
timeFrame: 1 month post-op, 2 months post-op and 3 months post-op
measure: Cost-effectiveness evaluation of both treatments using patient's study diary
timeFrame: 3 months post-op
measure: Change in pain medication usage
timeFrame: pre-operative, 1 month post-op, 2 months post-op and 3 months post-op
measure: Post-operative change in patient's treatment satisfaction using a dichotomous question and VAS-100 mm
timeFrame: 1 month post-op, 2 months post-op and 3 months post-op
Other outcomes:
measure: Confounding baseline parameters
timeFrame: pre-operative
Locations:
city: Geldrop
country: Netherlands
facility: Department of Anesthesia and Pain Management; St. Anna Hospital
state: Noord-Brabant
Study officials:
affiliation: Department of Anesthesia and Pain Management, St. Anna Hospital, Geldrop, The Netherlands
name: Willy Halim, MD, FIPP
role: PRINCIPAL_INVESTIGATOR
References: