Pain Clinical Trial
Official title:
Percutaneous Radiofrequency Denervation of the Cervical Facet Joints Compared With Cervical Medial Branch Block of the Facet Joints for Patients With Chronic Degenerative Neck Pain : A Prospective Randomized Clinical Study
Rationale: the facet joints are an important pain generator in chronic neck pain. The
beneficial effect of radio frequency treatment (RFD) of the cervical facet joints has been
described in a Randomized Clinical Trial (RCT) in patients with Whiplash Associated
Disorders. In patients with degenerative neck complaints a positive effect has been
described in observational studies. Given this positive effect performing a RCT of RFD in
this patient population is indicated.
Objective: to evaluate the effect of Radio Frequency treatment in patients with chronic
degenerative neck pain.
Study design: prospective, randomized, double blinded clinical trial. Study population:
patients older than 25 years, referred to the University Pain Center of Maastricht and the
Pain Center of Amphia hospital Breda, with chronic axial neck pain.
Intervention: patients with at least 3 months of neck pain without radiation to the arm
(only radiation beyond the shoulder) will be randomized in 2 groups. The first group (RFD +
local anesthesia-group=intervention group) will receive RF treatment adjacent to the medial
branch innervating the cervical facet joints after the application of bupivacaine 0.5 ml
(0.25%). The second group (local anesthesia-group=control group) will only receive the
application of 0.5 ml bupivacaine (0.25%) adjacent to the medial branch. The only difference
between the two groups is the RF-denervation of the medial branches.
Main study parameters/endpoints: the primary research question is to evaluate the extent of
pain reduction induced by RF treatment (RFD + local anesthesia-group=intervention group)
compared with the local anesthesia-group(control group.
Following evaluation tools are used : Numeric Rating Scale (NRS), Patient global Impression
of Change on a 7 point Likert Scale (PGIC), consumption of pain medication (MQS), Patient
Specific Functional Scale, Quality of life scale (RAND 36), Hospital Anxiety and Depression
scale (HADS), and Neck Disability Index (NDI, Dutch version).
Nature and extent of the burden and risks associated with participation, benefit and group
relatedness: Patients in the RFD + Local Anesthesia-group and Local Anesthesia-group will
undergo a physical examination before and 6 weeks after the intervention, by an independent
third party, this will be repeated at 3 and 6 months if abnormalities are observed. At each
of these time points the patients will receive questionnaires to fill out. A puncture of a
blood vessel is possible, diagnosed by injection of contrast, for which repositioning of the
needle is needed. Should accidental intravascular injection of local anesthetic occur, the
dose used is low and reports show that intravascular injection of bupivacaine 2,5 mg does
not pose clinical problems. The dura can be punctured; as a consequence contrast will flow
in the cerebrospinal fluid. The procedure will be stopped and repeated after a few days. In
theory a lesion of the nerve root is possible, but the needles are designed to avoid this,
this complication has not been seen since more than 10 years. Up till now, a transient pain
is occasionally described after the RF treatment. No hypesthesia or motor complications were
reported. Since the risks of RF treatment are reported low and more related to needle
placement there is no difference in risk and burden between the two treatment groups.
n/a
Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Outcomes Assessor), Primary Purpose: Treatment
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