To evaluate the effect of Radio Frequency treatment of the nerves innervating the cervical facet joints in patients with chronic degenerative neck pain.
ID
Source
Brief title
Condition
- Joint disorders
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
The primary research question is to evaluate the extent of pain reduction
induced by RF treatment (RFD group) compared with the control group.
Following evaluation tools are used : Numeric Rating Scale, Global Perceived
Effect on Likert Scale.
Secondary outcome
Consumption of pain medication (MQS), Patient Specific Functional Scale,
Quality of life scale (RAND 36), Hospital Anxiety and Depression scale (HADS),
and Neck Disabilty Index (Dutch version).
Background summary
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 RCT in patients with Whiplash Associated
Disorders. In patients with degenerative neck complaints a positive effect has
been described in observational studies.In a retrospective study, performed by
our research group, an effect of more than 50 % is reported. Given this
positive effect performing a RCT of RFD in this patient population is
indicated.
Study objective
To evaluate the effect of Radio Frequency treatment of the nerves innervating
the cervical facet joints in patients with chronic degenerative neck pain.
Study design
Prospective, randomized, double blinded clinical trial.
Intervention
Patients with at least 3 months of neck pain without radiation to the arm will
be
randomized in 2 groups. The first group (RFD group) will receive a RF treatment
adjacent to the medial branch innervating the cervical facet joints.RF
treatment is an accepted, extensively investigated and scientifically described
method to interrupt pain nociception. The second group (Control group) will
receive an injection of local anaesthetic (bupivacaine) near the cervical
medial branch.This is a therapeutic treatment .The efficacy of this last
treatment has been described in one Randomized Controlled Trial.
Study burden and risks
All patients will undergo a physical examination before and 6 weeks after the
intervention; 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.
The risks of the interventions are negligible and the procedures are well
tolerated. 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 Bupivacaïne 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 and the procedure always takes place with
fluoroscopic control. This complication has not been reported in more than 10
years. Up till now, a transient pain is occasionally described after the RF
treatment. No hypesthesia or motor complications were reported. Allergic
reaction to local anaesthetic or contrast agent is possible, but if known (part
of the history taking) is an exlusion criterion for the interventions.
P. Debeyelaan 25
Maastricht 6202 AZ
NL
P. Debeyelaan 25
Maastricht 6202 AZ
NL
Listed location countries
Age
Inclusion criteria
1) 1) Patient*s age > 25 year
2) Signs of degeneration on lateral X-ray
3) Cervical facets to be treated between C2 and C7
4) Pain for at least 3 months and conservative treatment prior to referral to the painclinic; medication (paracetamol, NSAID*s) and/or physical therapy
5) Neck pain NRS score * 5
Exclusion criteria
1) Radiation beyond the shoulder/radiculair pain
2) Shoulder pain/pathology
3) The complaints are directly related to traumatic event e.g. Whiplash (WAD)
4) Patient is pregnant, or pregnancy is suspected
5) Patient has a cardiac pacemaker, automatic defibrillator or any leads in the
neck area
6) Allergy to contrast media or drugs to be used in the procedure
7) History of anterior fusion at the cervical level to be treated
8) Patient is simultaneously participating in another device or drug study
related to cervical pain.
9) Patient has a spinal fracture, tumor or infection.
10) Patient has a central cord lesion in the cervical spine
11) Neurologic deficit
12) Evidence of disc herniation (extruded, sequestered on MRI imaging)
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 |
|---|---|
| ClinicalTrials.gov | NCT12 |
| CCMO | NL38863.068.12 |