Plantar heel pain. A pragmatic randomized single blinded clinical trial comparing the use of customized insoles, night splints and a barefoot technology shoe.

Proximal plantar fasciitis is an inflammatory reaction from chronic irritation
of the plantar fascia at its calcaneal origin, possibly resulting from chronic
irritation. It is characterized by pain and tenderness under the heel on
weightbearing, resulting in limitations of physical activity. The condition
affects about 10% of the population at some time during life.

Little is known of the clinical course of the condition, and some patients may
recover spontaneously. The most recent Cochrane review (2003) on interventions
for treating plantar heel pain concluded that there is limited high-level
evidence upon which to base clinical practice and asked for well designed and
conducted randomized trials.

A pragmatic randomized single blinded clinical trial was designed with the
objective to compare the use of customized insoles, night splints and a
barefoot technology shoe for the treatment of plantar heel pain syndrome.

This study is designed as a pragmatic prospective randomized single blinded
clinical trial to evaluate the difference in functional outcome after treatment
with customized inlays versus night splints and MBT shoes for the treatment of
plantar heel pain. The patients will be randomly allocated into one of the
three groups. Randomization will be performed by computer assignment and
concealed allocation. Blinding of patients is not possible, but the observer
will be blinded at follow-up. Analysis of the data will be performed in a
blinded fashion as well.

Group 1: Patients will wear orthopaedic insoles during daytime for at least 6
hours a day during 6 weeks minimum.
Group 2: Customized night splints will be used during sleeping hours for a
minimum of 6 hours per day and 6 weeks minimum.
Group 3: Participants will wear MBT shoes during daytime for at least 6 hours
per day and 6 weeks minimum.

All patients will be asked not to use additional treatments like physical
therapy or analgetics.
Minimal duration of treatment will be 6 weeks. After these 6 weeks, patients
are allowed to continue their prescribed treatment if complaints persist. If
not, patients can stop the treatment.

To our knowledge there are no potential risks for the included patients, as all
treatments are safe with little or no chance of complications.