Main objectiveTo describe the experienced pain sensations of temperature and to describe the different temperature sensitivity thresholds using Quantitative Sensory Test (QST) in the different patient groups.secondairy objectiveAs a measure of the…
ID
Source
Brief title
Condition
- Thyroid gland disorders
- Bone and joint injuries
- Neuromuscular disorders
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
The questionnaire has a minimum score of 0 and a maximum of 100 points. The
temperature-sensitive analysis, will compare the temperature in Celsius
degrees. The re-warming is given by Q as number of added energy in joules and
compared with de patient groups as well as the control group.
Secondary outcome
N.V.T
Background summary
The pathophysiology of cold intolerance is still unknown. Cold intolerance is a
disabilitating disease with a relatively high incidence for many different
patient groups (fracture patients 38% and nerve injury patients between 56 and
70%). A good diagnosis and definition for cold intolerance is missing.
Study objective
Main objective
To describe the experienced pain sensations of temperature and to describe the
different temperature sensitivity thresholds using Quantitative Sensory Test
(QST) in the different patient groups.
secondairy objective
As a measure of the quality of thermoregulation the re-warming pattern after
cooling the hands of the patient groups will be assessed. In addition the
relationships between re-warming patterns, sensory recovery and CI will be
assessed.
Study design
Measurements will initially start in the control group, followed by the cold
intolerant patients. The presence of cold intolerance is based on the Cold
Intolerance Symptom Severity questionnaire (CISS), developed by McCabe.
Patients will be informed by the doctor and receive the PIF (patient
information form). The patient will be required to reply with an answering card
indicating that they are willing to participate. When the answering card is
received an appointment for the measurements will be made and the patient will
be included in the study.
The patient will fill out the CISS and the RCIQ. General patient information
will be obtained such as gender, age, length, weight, smoking, date of trauma,
cause of trauma, medication, occupation, change of occupation, ability to work,
etc.
A qualified nurse at the pain treatment centre will measure the blood pressure.
Temperature of both hands will be assessed. Sensibility testing will be
performed with the Semmes and Weinstein monofilaments before applying the
temperature sensibility testing.
Sensitivity and pain temperature thresholds of the hands will be analysed with
a Temperature Sensory Analyser.
The hands of the patients will be cooled in water of 15 ºC and will stay in the
water for 90 seconds before quickly drying the hands by the researcher. The
hands will be placed underneath the thermographic camera. The re-warming of the
patient takes approximately 15 minutes.
Study burden and risks
The burden of the patient is a 1-time visit to our clinic. As to our knowledge
there are no risks for this study.
Dr. Molewaterplein 50-60
3015 GE, Rotterdam
NL
Dr. Molewaterplein 50-60
3015 GE, Rotterdam
NL
Listed location countries
Age
Inclusion criteria
minimum age >18, that are being treated in our hospital. All patients will have the pathological cold intolerance according to Ruijs et al., that is, a CISS score higher than 30.
Exclusion criteria
* Diseases, that influence the vascular system (such as Diabetes and Raynaud),
* Cardiac diseases and use of cardiac pharmacological supplements (α1,2-blockers and β1-blockers).
* Foreign material in the hand of the patient such as metal operation plates.
* Carpal tunnel syndrome
* Previous application of steroid injections if used in the past five years
* History of musculoskeletal medical conditions (e.g. Rheumatoid arthritis, Fibromyalgia)
* use of antihypertensive drugs
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 | NL29382.078.09 |