Primary goal of this study:1) To determin the percentage of structural damage caused by an ankle inversion trauma. 2) Investigate to which patient characteristics, anamnestic characteristics, physical examination and structural characteristics…
ID
Source
Brief title
Condition
- Joint disorders
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
Persistent complaints (measured with recovery on a 7-point Likert scale; pain
intensity on a 0-10 numerical rating scale; instability/feeling of instability
on a 0-10 numerical rating scale)
Secondary outcome
- Structural pathology (MRI, X-ray, 0-2 score for severity, seperately for each
item)
- Influence of persistent complaints on daily functioning (work, sports and
daily activities 0-5 point-scale)
Background summary
Ankle sprains are the most frequent injuries to the human locomotor system.
Yearly there about 600.000 new cases in the Netehrlands. About half of these
cases visit their general practitioner or the emergency department of the
hospital. The NHG-standard (Dutch Standard for General Practitioners) 'Ankle
sprains' holds guidelines for the diagnostics and treatment. This standard also
shows there is still a large number of gaps in the diagnostics and treatment of
these injuries. A recent study has shown that 20-40% of the patients with a
lateral ankle sprain still experiences pain after 3 months following the
injury. Moreover, the general practitioner gets visited rather frequently by
patients with persistent complaints. Persistent complaints like pain and
instability are frequently encountered, however it is unknown which patients
keep having persistent complaints despite of several interventions (see gaps
NHG-standard). It is also important to gain insight in the nature of these
persistent complaints or, what are the exact characteristics of these residual
complaints. An enhancement of the knowledge on this subject is of great value
to the general practitioner, so that they can inform their patients more
adequately and interventions and/or referrals can be adjusted to the patients
needs in an earlier stage. To gain insight in patients who, despite of all
kinds of interventions, still have persistent complaints it is essential to
carry out a cohort study in which patients with and without persistent
complaints fill-out an extensive questionnaire (anamnesis, function, recovery,
patient characteristics) and undergo an extensive physical examination.
Additionally, an extremity-MRI and an X-ray will be made of the ankle to
identify structural abnormalities (underlying pathology) that are possibly
associated with persistent complaints.
Study objective
Primary goal of this study:
1) To determin the percentage of structural damage caused by an ankle inversion
trauma.
2) Investigate to which patient characteristics, anamnestic characteristics,
physical examination and structural characteristics persistent complaints
following a lateral ankle sprain relate.
Secondary goals:
3) If structural characteristics relate to persistent complaints: to what
extent structural damage can be predicted (diagnosed) from anamnesis
and physical examination.
4) To evaluate the impact of persistent complaints following a lateral ankle
sprain on work, daily activities and sport participation.
5) To answer the question: What is the value of an X-ray for persistant
complaints after a lateral ankle trauma and what is the correlation between the
findings of the x-ray and the complaints?
6) To answer the question: What is the additional diagnostic value of an MRI
compared to an X-ray for patiënts with persistant complaints after a lateral
ankle trauma? Is there a complementary role of both radiological techniques?
Follow-up measurements:
7. To determint the percentage presistent complaints and re-sprains after 4
years of follow-up, as a result of a lateral ankle sprain.
8. To determine possible porgnostic factors for persistent complaints, 4-5
years after patients have visited the general practitioner with a lateral ankle
sprain.
Study design
To answer question 1-4, 350 patients who visited their general practitioner
6-12 months ago with a lateral ankle sprain will be included in a cohort study.
These patients will be selected from the files of general practitioners and are
contacted on behalf of the general practitioner to participate in the study.
All patients who meet the inclusion criteria will receive an extensive
questionnaire with questions about persistent complaints, treatments, patient
characteristics and anamnestic characteristics. Furthermore, all patients with
residual complaints will be selected along with a matched control group of
patients without persistent complaints (nested case-control design). These
patients will additionally be invited for a standardised physical examination,
X-ray and a Magnetic Resonance Imaging (MRI) scan.
After four years, al participating subjects will receive a questionnaire
informing on persistent symptoms.
Study burden and risks
Patients will receive additional radiation. However, the additional radiation
is small considering the location of the ankle joint, far away from vital or
radiation sensitive organs. The effective dose for an x-ray in two directions
is estimated at 0.002 microSv. Apart from this small additional radiation there
are no other risks connected to the addition of X-rays of the ankle joint.
Furthermore, the risks and burden for the patient are relatively small. The
study includes a one time visit to a nearby research location, the filling out
of a questionnaire, a physical examination and an MRI. In total it will cost
the patient about 90 minutes. The patient will be supported throughout the
entire study andcan, if wanted, get support to fill out the questionnaire. The
information provided by the researchteam will probably contribute to earlier
recognition and better treatment of persistent complaints following lateral
ankle sprains.
's-Gravendijkwal 230
Rotterdam 3015 CE
NL
's-Gravendijkwal 230
Rotterdam 3015 CE
NL
Listed location countries
Age
Inclusion criteria
1.) Consultation general pratitioner, minimally 6 months and maximally 12 months ago, for a ankle inversion trauma and 2.) Age 16 -65 years old
Exclusion criteria
- Familiar with systemic disorders which have a substational influence on the function of the musculoskeletal system (for example, neurological disorders such as ALS, MS and auto-immune disorders such a reumatology and psoriatric arthritis
- No knowlegde on the Dutch language in word and writing
- Contra-indication for MRI-scan
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 | NL30645.078.09 |