Primary Objectives: To describe the morphology of the carpal tunnel and median nerve 6 months after primary carpal tunnel release using ultrasonography and the electrophysiological properties of the median nerve as found by nerve conduction studies…
ID
Source
Brief title
Condition
- Peripheral neuropathies
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
The main study parameters are morphologic and electrophysiological findings of
the median nerve and carpal tunnel, and the comparison of these findings
between patients with and without symptoms.
Ultrasonograpy(US):
- Cross-sectional area of the median nerve halfway at the forearm and at the
carpal tunnel inlet and outlet.
- Qualitative aspect of the median nerve with assessment of nerve echogenicity,
vascularization, the aspect and thickness of the epineurial rim and perineurial
fascicle ensheathing.
- Qualitatieve assessment of any anatomical changes related to the median nerve
in the surgical region (e.g. scarring, hematoma, aspect of the ligament, etc.).
Nerve conduction studies(NCS):
- Motor and sensory nerve conduction velocities of the median nerve in the
forearm, wrist and palm of the hand segments.
- Sensory nerve action potential(SNAP) amplitudes of the 3rd and 4th digits.
- Distal motor latency (DML) of the median nerve, with standard stimulation
site at 6 cm.
- Compound muscle action potential (CMAP) amplitude of the abductor pollicis
brevis muscle.
- Sensory latency difference of the median nerve compared to the ulnar nerve
to the 4th digit.
Secondary outcome
- Difference in US(CSA) and NCS findings(NCV, SNAP amplitude, CMAP amplitude,
DML) preoperative and postoperative for the total group.
- Differences in US and NCS findings for subgroups based on severity of
clinical symptoms, and additionally on differences in the extent of NCS
abnormalities preoperative(mild, moderate and severe CTS) .
- Outcome after CTS measured with the BCTQ and Quick DASH questionnaire
correlated to the postoperative US and NCS findings.
Background summary
Carpal tunnel syndrome is the most common mononeuropathy with a prevalence of
5% and incidence of 1-2 per 1000 person-years. Treatment of CTS usually
involves surgical intervention with open carpal tunnel release, which has been
shown to be the most cost-effective therapy with lower recurrence rates in
comparison to most non-surgical options. Unfortunately, incidence of persistent
and recurrent symptoms is reported up to 31% after primary carpal tunnel
release.
According to the most recent version of the Dutch multidisciplinary guideline,
clinical assessment is the gold standard for diagnosing carpal tunnel syndrome.
However, both ultrasonography and nerve conduction studies have a high
sensitivity and specificity for detecting CTS, and can therefore provide more
objective and quantitative values for CTS evaluations. Furthermore, nerve
conduction studies and ultrasonography are valuable tools in cases that
clinically do not present the classic form of CTS or when additional
information is required on the severity of the compression and possibly the
presence of anatomical features leading to compression. Ultrasonography can be
used to assess the increased cross-sectional area (CSA) of the median nerve
associated with CTS, due to oedema and proliferation of fibrous tissue
surrounding the compression site.
After open carpal tunnel release, the CSA of the median nerve can remain
enlarged up to a year. In addition, the function of the nerve as measured with
nerve conduction studies does not return to normal completely. Furthermore,
surgery itself changes the morphology of the carpal tunnel, which makes the
correct diagnosis of persistent and recurrent CTS difficult. The available
studies on this topic primarily report the CSA and basic NCS findings at
different time points. Unfortunately, they do not give a more detailed
description of the median nerve and carpal tunnel after surgery. However,
especially in patients with recurrent and persistent symptoms, a comprehensive
morphological and functional description is needed to correctly diagnose CTS
and thus prevent unnecessary surgery with poor outcome.
Therefore, this study will provide a detailed morphologic and functional
description of the carpal tunnel and median nerve after primary carpal tunnel
release, adding information about the qualitative aspect of the median nerve
and qualitative assessment of any anatomical changes related to the median
nerve in the surgical region (e.g. scarring, hematoma, aspect of the ligament).
We will correlate these findings with a clinical, patient reported outcome
measure; the Boston Carpal Tunnel Questionnaire(BCTQ) and the Quick DASH
questionnaire, which will be taken postoperative. In addition, preoperative and
postoperative measurements with ultrasonography and nerve conduction studies of
different patient subgroups will be compared.
Study objective
Primary Objectives: To describe the morphology of the carpal tunnel and median
nerve 6 months after primary carpal tunnel release using ultrasonography and
the electrophysiological properties of the median nerve as found by nerve
conduction studies. Furthermore, we will compare the postoperative findings
between patients with and without symptoms.
Secondary Objectives: To compare ultrasonography and nerve conduction study
findings pre- and postoperative with each other, which will be done for the
entire group and for different subgroups based on CTS severity. Furthermore,
the outcome of primary carpal tunnel release will be evaluated by the BCTQ and
Quick DASH questionnaire and will be correlated to the findings of
ultrasonography and nerve conduction studies postoperative.
Study design
The study design is observational with non-invasive measurements and will be
performed at the Departments of Plastic Surgery and Neurology in the
Radboudumc, Nijmegen. The duration of this study will be 6 months
approximately. Study participation will include one extra visit to the hospital
for physical examination, nerve conduction studies and ultrasonography.
Study burden and risks
Patients participating in this study will have to visit the hospital one extra
time for physical examination, filling out two questionnaires, nerve conduction
studies and ultrasonography of the operated hand. All procedures will give
minimal discomfort and the visit will take 2 to 3 hours in total. No risks are
associated with the these procedures, therefore the risk can be categorised as
negligible(regarding the NFU guidelines). Patients without symptoms of
persistent or recurrent CTS will have no direct benefit, but for patients with
symptoms these procedures are similar to standard care for persistent or
recurrent CTS symptoms. Furthermore, these patients will also get a follow-up
according to standard care for persistent and recurrent CTS. In conclusion,
this study will give minimal discomfort and the procedures are not associated
with any risks. As it gives us valuable information which we can use to
diagnose recurrent and persistent CTS, we think it is justified to perform
this study.
Geert Grooteplein zuid 14
Nijmegen 6500HB
NL
Geert Grooteplein zuid 14
Nijmegen 6500HB
NL
Listed location countries
Age
Inclusion criteria
In order to be eligible to participate in this study, a subject must meet all of the following criteria: mentally competent men and women of 16 years or older who underwent an open carpal tunnel release for CTS less than half a year ago. Furthermore, subjects must understand and be able to communicate in the Dutch language.
Exclusion criteria
A potential subject who meets any of the following criteria will be excluded from participation in this study:
- No nerve conduction studies and ultrasonography performed prior to the carpal tunnel release
- Severe polyneuropathy affecting the operated extremity
- Cervical radiculopathy on the operated side
- Cerebral diseases affecting the operated extremity
- Other neuropathies affecting hand function in the operated extremity
Design
Recruitment
Medical products/devices used
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In other registers
| Register | ID |
|---|---|
| CCMO | NL65345.091.18 |