Primary Objective: To study whether nocturnal symptoms of CTS depend on wrist position and, if so, on which position. Identifying which wrist position aggravates CTS could help design a more effective splint. Secondary Objective: To study whether…
ID
Source
Brief title
Condition
- Peripheral neuropathies
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
Hypothesis 1: There is a specific position of the wrist causing nocturnal
symptoms. 1a.) This position is the same in all patients. Parameter: The
average angle of the wrist 15 minutes before every awakening compared to the
average angle of the wrist during 15 minutes at the same time in another night
in which the patient did not awake at that time.
Hypothesis 2: Nocturnal symptoms of CTS are related to a prolonged position of
the wrist. Parameter: variance in position of the wrist during the 60 minutes
prior to awakening compared with to variance in position during the same 60
minutes in another night in which the patient did not awake at that
time.
Secondary outcome
Hypothesis 3: Nocturnal symptoms of CTS are related to nocturnal drop in
systemic BP. Parameter: BP preceding nocturnal symptoms compared to BP on a
random chosen moment in that night in which the patient did not awake.
Hypothesis 4: Splinting of the wrist in neutral position results in a decrease
of the frequency of nocturnal symptoms of CTS of at least 50%. Parameter:
average frequency of awakenings during the first week compared to the second
week.
Background summary
Approximately 80% of patients with a compression of the median nerve in the
carpal tunnel (carpal tunnel syndrome, CTS) report nocturnal awakening due to
numbness or tingling of the hand. Patients typically move the wrist
repetitively upon awakening to alleviate their symptoms. The presumed reason
for this nocturnal aggravation is that the median nerve is subject to more
compression than in daytime and becomes ischaemic which results in
paraesthesia. There is no clear pathophysiological concept of why the nerve
should become more ischaemic during sleep. We envisage the following
possibilities:
• prolonged flexion of the wrist
• prolonged extension of the wrist
• drop in systemic blood pressure (BP) causing decrease in perfusion of the
vasa nervorum of the median nerve.
Circumstantial evidence in favour of either prolonged flexion or extension of
the wrist is found not only in the beneficial effect of movement after
awakening, but also in the fact that nocturnal splinting of the hand can work.
However, the evidence for effect of this conservative treatment is limited and
the angle in which the wrist should be immobilised is unknown. No one has yet
studied whether there is a correlation between the position of the wrist and
subsequent awakening due to symptoms of CTS.
Study objective
Primary Objective: To study whether nocturnal symptoms of CTS depend on wrist
position and, if so, on which position.
Identifying which wrist position aggravates CTS could help design a more
effective splint.
Secondary Objective: To study whether nocturnal symptoms of CTS depend on
decrease in systemic
BP.
Study design
Observational mono-center study with an exploratory character.
The expected duration is five
months.
Study burden and risks
In addition to standard care, patients will fill in a short questionnaire
regarding the severity of their complaints (Boston Carpal Tunnel Questionnaire,
BCTQ ± ten minutes). They will sleep with the LWG during seven nights and with
the ABPM at the contralateral arm during one night. Hereafter they will sleep
seven nights with a splint (standard care) combined with a registration button
and again fill in the BCTQ. The devices will be returned by the patient or
picked up by the investigator, depending on the patient*s preference. Sleeping
with the LWG is unlikely to influence wrist position, although this cannot be
formally tested. Sleeping with the ABPM can slightly reduce the quality of
sleep because patients may occasionally wake up during the measurement.
There are no risks associated with participation.
Albinusdreef 2
Leiden 2333 ZA
NL
Albinusdreef 2
Leiden 2333 ZA
NL
Listed location countries
Age
Inclusion criteria
• Electrophysiologically proven CTS
• History of nocturnal complaints of CTS leading to awakening >= two times per night
• Age >= 18 years
• Ability to provide informed consent
Exclusion criteria
• Working night shifts during the study period
• Any skin condition of the hand that would make wearing of the Leiden Wrist Goniometer (LWG) uncomfortable.
• The need for immediate surgery or other treatment for CTS
• Any reason patients can not wear an ABPM on the contralateral arm, such as previous brachial lymphadenectomy
Design
Recruitment
Medical products/devices used
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 | NL53671.058.15 |