To investigate the pain phenotype of patients with hand OA. To investigate the prevalence of neuropathic pain symptoms and central sensitization and their determinants in patients with painful hand OA. To investigate the presence of small- and large…
ID
Source
Brief title
Condition
- Joint disorders
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
The main outcome will be pain phenotypes for patients with hand OA.
Secondary outcome
- Determinants of sensitization and neuropathic pain symptoms in the patients
with hand OA
- Prevalence of fibromyalgia as measured by the ACR 2011 classification criteria
- Determinants of fibromyalgia in patients with hand OA
- Prevalence of generalized small fiber pathology as measured by QST and CCM
- Determinants of generalized small fiber pathology in patients with hand OA
- Validity of the simplified QST test set as a screening tool for neuropathic
pain symptoms compared to the comprehensive QST
- Validity of the painDETECT questionnaire as a screening tool for neuropathic
pain symptoms compared to the comprehensive QST
- Association between severity of inflammation on ultrasonography of the hand
joints and central sensitization and small fiber pathology
- Association between serum (ARGS, HsCRP, CPRm, VICM) and urine (uCTX2)
biomarkers and central sensitization and small fiber pathology.
Background summary
Pain is a common and difficult to treat symptom in patients with hand
osteoarthritis (OA). The exact nature and cause of pain in hand OA are unknown.
We hypothesize that in its pathophysiology, non-nociceptive mechanisms such as
central sensitization and small fiber pathology play a role.
Study objective
To investigate the pain phenotype of patients with hand OA. To investigate the
prevalence of neuropathic pain symptoms and central sensitization and their
determinants in patients with painful hand OA. To investigate the presence of
small- and large fiber pathology and central sensitization and their
determinants using quantitative sensory testing and cornea confocal microscopy
(CCM). To investigate the validity of screening tools for assessment of central
sensitization.
Study design
cross sectional observational study.
Study burden and risks
This observational study will have minimal burdens and risk for the
participants. In the first study visit patients will have their medical history
taken, undergo physical examination consisting of assessments of the vital
signs (weight, height, waist circumference, pulse and blood pressure), joint
assessment, and grip strength measurements. In addition, a blood and urine
sample will be collected. Answering the questionnaires is physically taxing,
but does not carry a risk. To obtain the blood sample a venapunction will be
performed, which has a slight risk of bruising and pain. After the first visit
the patients will be sent questionnaires regarding the severity and complaints
of hand OA, as well as questionnaires regarding medical history, comorbidities,
family history, use of medication, quality of life, illness perceptions, coping
strategies, central sensitization and dealing with pain. In the second visit,
part of the patient group will visit the Anesthesia & Pain Research Unit, LUMC,
to undergo the Quantitative Sensory Testing and the Cornea Confocal Microscopy.
These investigations do not give additional risks, but may be experienced as
slightly unpleasant. Patients will also visit the Rheumatology outpatient
clinic, LUMC, for ultrasonography. Patients will visit the hospital 2 times
extra for this study.
Albinusdreef 2
Leiden 2333ZA
NL
Albinusdreef 2
Leiden 2333ZA
NL
Listed location countries
Age
Inclusion criteria
- Age 18-80
- Hand osteoarthritis according to the ACR criteria
- Hand pain of at least 30mm on a 100mm VAS
- Chronic hand pain
Exclusion criteria
Part 1:
- Known inflammatory rheumatic diseases
- Psoriasis
- Seropositivity for rheumatoid factor of anti-CCP antibodies
- No understanding of the Dutch language
Part 2:
- Fibromyalgia (Following the ACR 2011 classification criteria)
- Neurologic disorders interfering with the measurements or pain perception
- Carpal tunnel syndrome interfering with the measurements or pain
perception(i.e. bilateral CTS)
- History of chemo- and/or radiotherapy
- Spinal surgery or spinal trauma with lasting complaints interfering with the
measurements or pain perception
- Cognitive impairment or psychiatric disorders interfering with the
measurements or pain perception
- Pregnancy or breast-feeding
- Eye surgery for glaucoma or keratoconus, or other surgery of the cornea in
the three preceding months
- Presence of an implantable cardioverter-defibrillator (ICD), neurostimulator
or pacemaker
Design
Recruitment
metc-ldd@lumc.nl
metc-ldd@lumc.nl
metc-ldd@lumc.nl
metc-ldd@lumc.nl
metc-ldd@lumc.nl
Followed up by the following (possibly more current) registration
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Other (possibly less up-to-date) registrations in this register
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In other registers
| Register | ID |
|---|---|
| CCMO | NL78432.058.21 |