The purpose of this study is: 1) to develop a method to quantify muscular fat content in brachial plexus injury patients;2) to investigate whether muscular fat content is more in the affected arm compared to the contralateral arm in BPI patients;3)…
ID
Source
Brief title
Condition
- Neuromuscular disorders
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
The primary study parameters are:
1) the percentage of muscular fat in the musculus biceps brachii and triceps
of the affected and contralateral arm.
2) The Goutallier grading will be used to compare qualitatively grading method
with the quantifative grading method of muscular fat content.
The m. biceps brachii and triceps of the contralateral non affected arm will be
used as a control muscles.
Secondary outcome
Secondary study parameters are:
1) elbow flexion and extension range of motion and strength
2) quality of life questionnaire: SF36 and DASH
Background summary
A brachial plexus injury (BPI) is the most severe nerve injury of the
extremities and the majority of these patients have residual muscle weakness.
To improve the utility of their arm, they need nerve and/or secondary surgery.
Long-term denervation results in muscle atrophy, fatty degeneration and
interstitial fibrosis of the muscle. Quantitative tools which assess muscular
fat content could improve insight in the extent of muscle degeneration and
could facilitate a better treatment strategy. In previous studies, the
three-point Dixon MRI has been used to measure muscular fat content in lean and
obese children. Furthermore the three-point Dixon MRI has been used as a marker
of muscle weakness in children with Duchenne Muscular Dystrophy.
Study objective
The purpose of this study is:
1) to develop a method to quantify muscular fat content in brachial plexus
injury patients;
2) to investigate whether muscular fat content is more in the affected arm
compared to the contralateral arm in BPI patients;
3) to evaluate differences in muscular fat content between patient groups with
insufficient recovery and with sufficient recovery of muscle function.
Study design
A comparative pilot study will be performed to quantify differences in muscular
fat content by three-point Dixon MRI between two groups of BPI patients. The
first group will include patients with insufficient recovery of the m. biceps
brachii (MRC 0-3) who underwent Steindler flexorplasty to improve their elbow
flexion. The second group will include patients with sufficient recovery of
their m. biceps brachii (MRC 4) who did not need secondary surgery to improve
elbow flexion. An MRI will be performed of both upper arms, together with
fysical examination and two quality of life questionnaires.
Study burden and risks
Potential risks are considered minimal because this is a non invasive study. In
patients with a Steindler flexorplasty, could observe some warming of the screw
in the distal humeral bone. However, this risc is considered minimal because
the screw is MRI compatible (pure titanium). While the patients participating
in this study may not directly derive any immediate benefits, the results of
the study should improve methods to quantify muscle weakness in brachial plexus
injury patients.
Albinusdreef 2, Postbus 9600
2300 RC Leiden
NL
Albinusdreef 2, Postbus 9600
2300 RC Leiden
NL
Listed location countries
Age
Inclusion criteria
Brachial plexus injury diagnosed by orthopaedic surgeon or neurosurgeon.
Patiënts have to be in end stage of neural regeneration i.e. at least 2 years after trauma or nerve surgery
Exclusion criteria
Bilateral brachial plexus injury.
Not 3 tesla MRI eligible due to any reason.
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 | NL31766.058.10 |