RCT: Conservative treatment of clavicular fractures with kinesio tape or only a sling

Clavicular fractures are frequently diagnosed fractures on the emergency
departments. Fractures of the clavicle or shoulder have an incidence of 115 per
100.000 persons in the Netherlands (1). Operative treatment is performed in
some cases, but is associated with more complications, but lower non-union
rates (2). However most patients are treated conservative by a sling in
combination with analgesics. Besides treatment with a sling there are some
different options for conservative treatment. In the past the use of an eight
clavicular bandage is investigated in a randomised controlled study (3). The
results showed that patients experienced more pain during the first day. There
were no statistically differences in satisfaction, return to activities or
functional outcome.

In the Netherlands kinesio tape is part of the conservative treatment in some
hospitals, however there are no clinical trials about the efficacy of kinesio
tape in patients with a clavicular fracture (2). The experience of kinesio
tape for clavicle fractures in daily practice implicates that it reduces pain
and increases mobility, however there are no studies performed to approve these
statements.

Kinesio tape is used for different (sport) injuries and some other conditions.
The effects of kinesio tape are widespread, although the mechanism is not
completely understood. The thought is that it improves lymphatic and blood
circulation, reduces pain, realigns joints and reduces muscle tension.

Kinesio tape is used by physiotherapist for different shoulder issues.
Saracoglu et al performed a systematic review about the effects of kinesio tape
in addition to physiotherapy in cases of impingement syndrome (4). In this
review three studies were included, which investigated the effectiveness of
taping on pain and function in addition to physiotherapy. There was a positive
effect on pain and function, but not all results were significant.

There are no studies performed about the effectiveness of kinesio tape in
patients with clavicle fractures. The aim of our study is to investigate the
effectiveness of kinesio tape in patients with clavicle fractures in comparison
to the standard treatment (with sling). Our main outcome is the NRS-pain score.

The aim of our study is to investigate the effectiveness of kinesio tape in
patients with clavicle fractures in comparison to the standard treatment (with
sling). Our main outcome is the NRS-pain score.


Primary Objective: Is there a difference in the decrease of NRS-score between
patients treated with kinesio tape and a sling or a sling only?

Secondary Objective(s):
Is there a difference in the use of analgesics between both groups?
Is there a difference in the time to return to work, school or sport between
both groups?
Is there a difference in the Constant score or DASH after six weeks?
Is there a difference in the number of patients with non-union after six weeks?

This is a randomized controlled trial. There are two treatment groups in this
study. Patients treated only with a sling (group 1) and patients treated with a
sling and kinesio tape (group 2). The duration of the study is 6 weeks for each
patient.

Time schedule
T0: Patients are diagnosed with a clavicular fracture at the Emergency
Department and will be approached for participation, when they meet the in- and
exclusion criteria. Patients will be randomized in group 1 or 2 and fulfill a
questionnaire (hand dominancy, work, sport) after informed consent is obtained.

After randomization
Group 1 (treatment with sling)
T0: Patients will get a sling and instructions about the use of analgesics and
the diary.
T0-1: Patients keep a diary about the NRS-score and the use of analgesics.
T1 (after 1 week): Patients have an appointment at the outpatient clinic to
hand in the diary and get instructions about exercises for their shoulder.
T2-5 (after 2, 3, 4 and 5 weeks): Patients get an email or phone call about
their NRS-score, use of analgesics and about return to work/school/sport
T6 (after 6 weeks): Patients have an appointment at the outpatient clinic for
an X-ray and are asked to fulfill the DASH questionnaire and the constant score
will be completed.

Group 2 (treatment with sling and kinesio tape)
T0: Patients will get a sling and kinesio tape. They get instructions about the
use of analgesics and the diary.
T0-1: Patients keep a diary about the NRS-score and the use of analgesics.
T1 (after 1 week): Patients have an appointment at the outpatient clinic to
hand in the diary and get instructions about exercises for their shoulder and
replace the kinesio tape.
T2 (after 2 weeks): Patients return to the outpatient clinical for replacement
of the kinesio tape and are asked about the NRS-score, use of analgesics and
about the return to work/school/sport
T3 (after 3 weeks): Patients get an email or phone call about their NRS-score,
use of analgesics and about the return to work/school/sport. They can remove
the kinesio tape.
T4-5 (after 4 and 5 weeks): Patients get an email or phone call about their
NRS-score, use of analgesics and about return to work/school/sport

T6 (after 6 weeks): Patients have an appointment at the outpatient clinic for
an X-ray and are asked to fulfill a small questionnaire and the DASH
questionnaire and the constant score will be completed.

Patients in group 2 will be treated with kinesio tape.
The kinesio tape is a product of BSN Medical, which is called Leukotape K.

The risks for participants are very small. The only risk is irritation of the
skin. The burdens of this study include one extra visit (group 2) and
questionnaires for both groups. Those burdens are small and the aim of the
study is to investigate another treatment method. This could improve the
treatment of clavicle fractures in the future and hopefully would reduce the
pain in patients with a clavicle fracture.