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?
ID
Source
Brief title
Condition
- Spinal cord and nerve root disorders
- Nervous system, skull and spine therapeutic procedures
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
The main study parameter to measure efficacy of both treatments is pain. Pain
is measured using a 100 mm Visual Analogue Scale (VAS-100 mm) and a Verbal
Rating Scale using 5 categories (VRS-5).
Secondary outcome
Secondary endpoints will include:
- The Short Form 12-item questionnaire for general health (SF-12);
- The Neck Disability Index (NDI) for neck functioning during ADL;
- 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;
- Changes in limitations in sports and work, including return to work-rate;
- 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;
- Patient*s study diary for cost-effectiveness evaluation, including use of
(escape) medication and physician visit(s);
- Difference in patient*s drug regime before and after treatment;
- Patient satisfaction with treatment (result) measured dichotomously via a
question and continuously via VAS-100 mm.
Background summary
Pain management in cervical disc herniation relies initially on conservative
care (rest, physiotherapy, and oral medications). Once conservative treatment
has failed, different percutaneous minimally invasive (radiological) procedures
can be applied to relief pain. Percutaneous Cervical Nucleoplasty (PCN) is the
most often applied technique on the cervical level with a low risk of thermal
damage. A variety of published studies have demonstrated PCN to be both safe
and effective. Pulsed Radio Frequency (PRF) of the dorsal root ganglion is also
a popular pain treatment modality for a variety of pain syndromes. The
application of PRF is also a safe and useful intervention for cervicular pain.
Although these treatment modalities are described in the literature, the
available evidence for efficacy is not sufficient to allow definitive
conclusions on the optimal therapy to be made.
Study objective
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 design
A single-centre double-blind randomized clinical trial.
Intervention
Included patients will be randomized into either of two study groups, receiving
cervical nucleoplasty or PRF.
Study burden and risks
Regardless the treatment group to which the patient is allocated, he/she may
benefit from pain reduction and function improvement. PCN and PRF are known as
non or minimally invasive procedures, therefore no full anaesthetic is needed
and no overnight stay in the hospital is required. Neck bracing for three days
is needed and gradually increasing neck loading in the next four weeks
afterwards. Moreover, patients consenting to participate are not allowed to
receive physical therapy during study participation and will have to return for
longer follow ups and more often. Follow-up visits are scheduled three times
after treatment. Each visit will take approximately 30-40 minutes.
Both treatment groups have their own reported risks in terms of side
effects/complications, however these are small in number, and mild and
transient of nature. The majority of studies reported no significant
complications related to PCN. PRF accounts as a safe treatment since the intent
is specifically not to cause tissue injury. Therefore neurological side effects
or complications with PRF are rarely mentioned.
Patients with insufficient relief of symptoms three months after treatment will
be offered immediate and appropriate further pain management.
Bogardeind 2
5664 EH Geldrop
NL
Bogardeind 2
5664 EH Geldrop
NL
Listed location countries
Age
Inclusion criteria
- Diagnosed with radiographically confirmed contained cervical disc herniation on MRI at one level
- Received a diagnostic block
- Failed conservative therapy during at least six weeks
- Radicular pain with or without neck pain, corresponding to herniated level
- VAS-100 mm pain score at least 50 mm or higher
- Patients have a stable drug regime
Exclusion criteria
- Contraindication for intervention with nucleoplasty or pulsed radio frequency
- Sequestered or extruded disc fragment, spondylolisthesis, vertebral fracture or spinal stenosis
- Uncovertebral or facet arthrosis
- Previous surgery or any type of infiltrations at the indicated cervical level
- Contained cervical disc herniation >1/3 spinal canal
- Radiographically confirmed loss of >30% disc height compared to adjacent cervical level
- Severe disc degeneration
- Unstable medical condition
Design
Recruitment
Followed up by the following (possibly more current) registration
No registrations found.
Other (possibly less up-to-date) registrations in this register
No registrations found.
In other registers
| Register | ID |
|---|---|
| CCMO | NL39783.015.12 |