To determine whether the ulnar nerve*s cross-sectional area decreases over time after endoscopic in situ neurolysis, and whether this correlates with electrophysiological findings.
ID
Source
Brief title
Condition
- Peripheral neuropathies
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
The main study parameter is the cross-sectional area (CSA) of the ulnar nerve,
measured at 6 different locations in the arm, measured preoperatively and in
the course of time after surgery.
Secondary outcome
- CSA ratio
- Nerve conduction velocity
- Thickness m. interossei dorsalis I
- Length of swelling
- Microstructure variables
- Arm/hand function
Background summary
Ulnar nerve entrapment (UNE) is the most common neuropathy after carpal tunnel
syndrome. It can be diagnosed by a combination of clinical and
electrophysiological findings. Electrophysiological tests give some information
about the location of the entrapment, but it does not provide information about
the exact location. Ultrasonography might provide this, by making the location
of entrapment visible, because the nerve shows an increased cross-sectional
area proximal to the entrapment site. Knowing the exact location of the
entrapment is essential, because opening the cubital tunnel during surgery
without knowing the exact location could miss the place of entrapment. Next to
that, long term follow-up with ultrasonography can provide information about
the state of the recovery of the nerve, in terms of recurrent or persisting
disease. Given the improved high resolution ultrasound (HRU) devices, more
precise and detailed information could be obtained.
Study objective
To determine whether the ulnar nerve*s cross-sectional area decreases over time
after endoscopic in situ neurolysis, and whether this correlates with
electrophysiological findings.
Study design
This is a descriptive study with a longitudinal study design.
Study burden and risks
Patients who participate in this study will receive three additional
ultrasonographies, one additional electrophysiological test, and one additional
clinical examination. The patients are asked to fill out a questionnaire to
assess hand function during every visit. These measurements and research acts
will be performed during the hospital visits that are part of the standard
treatment protocol. Patients will be asked to bring one additional visit to the
hospital that is not part of the treatment protocol. Because participation in
this study has no consequences for the surgical treatment that patients
receive, this study has no benefits for the participating patients. The benefit
lies potentially in future UNE patient groups. The ultrasonographies will not
be harmful, because no contrast agents will be used, and no sensitive organs or
embryo*s are visualized. One additional electrophysiological test will be
performed. The electrophysiological examinations can be unpleasant, but there
are no risks associated with the tests. This study is group-related as it is
evident that observations on the ulnar nerve after ulnar nerve release, only
can be performed in UNE patients.
Hanzeplein 1
Groningen 9713 GZ
NL
Hanzeplein 1
Groningen 9713 GZ
NL
Listed location countries
Age
Inclusion criteria
- adults of 18 years of age or older
- those diagnosed with ulnar nerve entrapment who received an indication for surgery
- decisionally capacitated
- written informed consent
Exclusion criteria
- (history of) generalized neuropathy
- (history of) polyneuropathy
- earlier ulnar entrapment neuropathy
- afunctional ulnar nerve
- patient is unlikely to complete follow-up (e.g. relocation)
- patient has a pace maker
- BMI > 30
Design
Recruitment
Followed up by the following (possibly more current) registration
No registrations found.
Other (possibly less up-to-date) registrations in this register
In other registers
| Register | ID |
|---|---|
| CCMO | NL43057.042.13 |
| OMON | NL-OMON25209 |