PILOT
Conservative treatment of midclavicular fractures with Kinesio® clavicular tape and sling vs sling

Fractures of clavicula are frequently diagnosed. Of all fractures about 4 % are
fractures of the clavicula. Of these about 75% are mid-shaft (3% of all
fractures). Conservative sling treatment of the mid-shaft fractures dominates
the therapeutic approach. Complications encountered with this procedure are
mal-union, non-union, pain, restrictions of arm movements and cosmetic. The
treatment has an acceptable prognosis with relative little additional
morbidity. When focussing on quality of life after sling treatment there are
still many complaints of pain, weakness of muscular strength and rapid fatigue
of the arm muscles on exertion during the first weeks. A new type of elastic
tape, Kinesio® clavicle tape in combination with sling treatment gave
remarkable better results in a small pilot set-up. Relief of pain and better
shoulder function was immediately experienced by all patients. These effects
lasted the first weeks.
Tape treatment has never been compared to sling treatment in a RCT.

Goal of our study is to compare conservative treatment of mid-shaft clavicle
fracture with Kinesio® clavicle tape combined with sling to conservative
treatment with sling.


Goal of our Pilot-studie is;
Investorise if the VAS-score, the DASH questionairy and the Constant Shoulder
Test are sifficient enough for our greater RCT-studie about Kinesio® tape for
clavicle fractures. Beside this we want to investicate how the placobo-tape
works and if it is possible to hold it apart from de working tape, for the
patient as well the doktor.

We will perform a prospective clinical pilot trial in our hospital *Onze Lieve
Vrouwe Gasthuis* In this randomised, double-blind trial we compare an small
experimental group (10 patients) and a small control group (10 patients) and a
group without tape (10 patients). Inclusion- and exclusion criteria are
formulated. The experimental group gets the Kinesio® clavicle tape application
during 3 weeks in combination with sling treatment. The other group gets the
sling treatment in combination with a placebo tape application. The third group
gets only sling. This treatment is for 3 weeks. Tape will be exchanged every 5
days. After a period of 3 weeks only sling treatment continues, if requested by
the patient. Outcome analysis for physical functioning and pain as our primary
endpoints are measured by standard clinical follow-up and questionnaires: the
Disabilities of the Arm, Shoulder and Hand (DASH) score, the Visual Analogue
Scale (VAS) pain score, the Constant shoulder score. Furthermore, radiographs
will be made at the useable times day 1 and day 10. After 1 month the pilot
trial is finished. We also use a questionaire regarding the tape to analyze
whether the placebotape will not have too much effect on the result of the
research.

Furthermore treatment will be given compare the normal treatment of a
claviculair fracture.


Beneath is schema from the dates and investications

Tijdstip van evaluatie VAS DASH RONTGEN Constant Shoulder Test
Day 1 X X X X
Day 10 X X X X
Day 20 X X X

One group will receive the treatment with kinesio tape in addition to the
sling, the other group will receive a tape without pressure and can be
considered a fake tape. The last group don't get tape they only get a mitella.

Skin irritation could occor due to the use of tape.
The questions that need to be answered for the study will take about 10 to 15
minutes per visit. These inquiries are most of the time combined with regular
visits.
The patients have to visit the Hospital 2 additional times to change the tape