The primary objective in this study is to detect the presence of supra-spinal central sensitization in patients with chronic neck pain secondary to cervical facetal arthropathy. We aim to show this by comparing the pressure-pain thresholds (PPT; the…
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Brief title
Condition
- Joint disorders
- Bone and joint therapeutic procedures
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Research involving
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Intervention
Outcome measures
Primary outcome
Our primary endpoint is to detect generalized hyperalgesia, defined as a
decrease in pressure-pain thresholds (PPT) of more than 30% in a distal site
(the rectus femoris muscle) outside their reported areas of pain, vs. healthy,
pain-free controls. A further objective is to subsequently track the these PPT
changes in this group of patients through their diagnostic and therapeutic
process, to ascertain if this hyperalgesia predisposes them to poor treatment
response or if this hyperalgesia in fact, abates with the ablation of the
peripheral painful input. Important secondary endpoints include electrical
wind-up testing and DNIC testing which provide further information regarding
vulnerability to central sensitisation or it progression, and may also help
predict response to therapeutic intervention. Thermal detection testing helps
identify patients with nerve damage which could also predispose to central
sensitization.
Secondary outcome
Secondary study parameters, in particular the rest of the QST battery, further
reinforces the primary objective. Windup ratio will serve to confirm the
presence of spinal central sensitisation, while measurement of the DNIC
response will allow insight into vulnerability for (further) progression of
central sensitisaton. Thermal detection thresholds and electrical pain
detection thresholds will help detect nerve damage which again can predispose a
patient to supra-spinal central sensitization.
Because chronic neck pain, like many other chronic pain conditions, is fraught
with numerous psychosocial complications, the quality of life and degree of
perceived disability will also be evaluated using the following questionnaires:
1. Quality of life (1 questionnaire): SF-36 (Medical Outcomes Study Short-Form
General Health Survey (Ware, Jr. and Sherbourne 1992;Aaronson et al. 1998))
2. Sleep disturbance (1 questionnaire): MOS Sleep Scale (Hays and Stewart, 1992
R.D. Hays and A.L. Stewart, Sleep measures)
3. Disability: Neck Disability Index (NDI) (H Vernon and S Mior, 1991)
Background summary
Neck pain is one of the most common chronic pain conditions encountered in
modern society. In the Netherlands, neck pain complaints (in combination with
back pain) are amongst the top 3 reasons that patients call on their general
practitioner. The point prevalence of chronic neck pain is 110 per 1000 in men
and almost 180 per 1000 in women (25 years and older, by gender, standardized
to the population of Netherlands in 2000). In 2005, neck and back pain
complaints accounted for 867.2 million Euros or 1.3% of total healthcare costs
in Netherlands.
Koelbaek Johansen et al (1999) and Chien et al (2009) both found generalized
hyperalgeisa in whiplash patients with chronic neck pain, a result compatible
with generalized central sensitisation or disordered central pain processing.
Such central hypersensitivity can, e.g., result in an amplification of
nociceptive input arising from a peripheral focus in the neck. Cervical facetal
arthropathy is considered a leading cause of both traumatic and idiopathic
chronic neck pain. Hence, we have chosen to study normal clinical practice in
patients with cervical facet arthropathy, with the aim of detecting supraspinal
central sensitisation via generalized hyperalgesia as defined by a clinically
relevant decrease in pressure-pain thresholds of more than 30% (compared to a
healthy population) in a site distant from their reported areas of neck pain.
Study objective
The primary objective in this study is to detect the presence of supra-spinal
central sensitization in patients with chronic neck pain secondary to cervical
facetal arthropathy. We aim to show this by comparing the pressure-pain
thresholds (PPT; the primary parameter) in a distal site (the rectus femoris
muscle) of 69 patients which chronic neck pain secondary to cervical facetal
arthropathy versus 23 age and sex-matched healthy controls. This finding is
important as we have reasons to believe that central sensitization will
negatively impact the outcome of therapeutic intervention in this group of
patients. We aim to demonstrate this via serial QST measurements accompanying
the patients* diagnostic and therapeutic process.
The measurement of the secondary study parameters, in particular the rest of
the QST battery, further reinforces this primary objective. Thus determination
of the windup ratio will serve to confirm the presence of spinal central
sensitisation, while measurement of the DNIC response will allow insight into
vulnerability for (further) progression of central sensitisaton. Thermal
detection thresholds and electrical pain detection thresholds will help detect
nerve damage which again can predispose a patient to supra-spinal central
sensitization. Because chronic neck pain, like many other chronic pain
conditions, is fraught with numerous psychosocial complications, the quality of
life and degree of perceived disability will also be evaluated using the SF-36,
Neck Disability Index (NDI) and MOS Sleep scale questionnaires.
Study design
The study has a cross-sectional design, and compares patients with painful
cervical facet arthropathy to healthy-matched controls using a QST measurement
battery. After written informed consent, the patients will be given a set of
study questionnaires that require a maximum of 15 min to complete. The
questionnaires include the SF-36, Neck Disability Index (NDI) and the MOS Sleep
Scale. The patient will then undergo their first QST measurement. This is then
followed by diagnostic block testing with both lignocaine 1% and bupivacaine
0.5%. A second QST measurement is done 1 week after the diagnostic blocks. If
either of the diagnostic blocks is positive the patient will then receive a
therapeutic medial branch radiofrequency denervation, otherwise, the patient
will be treated conservatively. Each QST session is entirely identical to the
previous, allowing serial comparisons to be made. The patients will undergo a
total of 3 QST measurements: one prior to diagnostic blocks, one after
diagnostic blocks and one three months after treatment. The diagnostic and
therapeutic process depicted in this protocol is entirely identical to routine
clinical practice.
Study burden and risks
It is estimated that the 3 specified questionnaires will take a maximum of 15
minutes to complete. Each QST session requires up to 60 min to complete. All
patients presenting with chronic neck pain complaints will undergo at least QST
1. Those who are clinically diagnosed with painful cervical arthropathy will
undergo another 2 QST sessions, conducted over 3 months. As the QST sessions
has been integrated into our work process, the patient will only need to make
an extra 2 trips compared with routine clinical practice.
Expected findings:
We anticipate that we will demonstrate generalized hyperalgesia as a sign of
supra-spinal central sensitization in significant proportion patients with
chronic neck pain as a result of painful cervical facet arthropathy.
Accompanying this finding will be another subgroup of patients with a
significant degree of windup and poor DNIC response. Our postulation is that
these patients will respond more poorly to both diagnostic and therapeutic
blocks.
Postbus 9101
6500 HB Nijmegen
Nederland
Postbus 9101
6500 HB Nijmegen
Nederland
Listed location countries
Age
Inclusion criteria
1. Male and female patients who are 18 years or more of age.
2. Patients with a history of chronic, function-limiting neck pain of at least 3 months duration.
3. Patients who are able to provide voluntary, written informed consent to participate in this evaluation.
4. Patients willing to return for follow-ups.
5. Patients without a history of recent surgical procedures (i.e. within the last 6 months)
Exclusion criteria
1. Patients with uncontrolled major depression or psychiatric disorders.
2. Patients with recent history of heavy opioid usage, chronic alcoholism or substance abuse.
3. Patients with acute or uncontrolled medical illness, malignancy or poorly controlled epilepsy.
4. Patients with chronic severe conditions that could interfere with the interpretations of the outcome assessments.
5. Patients with fibromylagia or painful syndromes of unknown origin or associated with diffuse pains.
6. Female patients who are pregnant or lactating,
7. Patients unable to tolerate prone or lateral position.
8. Patients with histories of adverse reactions to local anesthetic or steroids
9. Patients with anatomical abnormalities on cervical spine X-ray that may result in technical difficulties for blocks
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 | NL30653.091.09 |