The Analysis and Applications of Dynamic Impression Insole

Taipei Veterans General Hospital

Status and phase: Completed; Early Phase 1

Conditions: Metatarsalgia

Treatments: Procedure: Dynamic impression insole; Procedure: 9-mm uncompressed Plastazote; Procedure: 7-mm Ethylene Vinyl Acetate (EVA); Procedure: Custom molded insole

Study type: Interventional

Funder types: Other

Identifiers

NCT01629173

97-11-12A

Details and patient eligibility

About

The aim of the study was to investigate the effectiveness of dynamic impression insoles on plantar pressure and pain reduction. A dynamic impression insole was made by sequential padding with Plastazote and P-cell under daily walking compression. The pain levels and plantar pressure with the use of dynamic impression insole were assessed and compared with 7-mm Ethylene Vinyl Acetate (EVA) control, 9-mm uncompressed Plastazote and custom molded insoles. Plantar pressure was measured by a Pedar-X mobile system, and pain level was assessed using a Visual Analog Scales.

Full description

Toe deformities may cause prominence of the metatarsal heads (MTH) and distal displacement of fat-pad cushion beneath the MTH, resulting in the metatarsal pain. Foot pain frequently leads to limitation of activities of daily life and deterioration of life quality. Foot orthoses have been commonly used in clinical practice to reduce plantar pressure and subsequent pain. However, the therapeutic efficacies of custom molded insoles with a metatarsal support vary widely with their designs and materials. We designed a simple and effective method that a dynamic impression insole was made by sequential padding of foams with different compressibility under successive dynamic impression in daily walking. A piece of metatarsal pad and arch support made of EVA was attached to the bottom of impressed insole just proximal to the first, second, and third MTH according to the foot impression. Fifty participants with metatarsal pain were recruited from the podiatry outpatient clinic of Taipei Veteran General Hospital. The plantar pressure measurements were carried out under a comfortable and stable walking speed preferred by the participants one month after the dynamic impression and custom molded insoles were well fabricated. All pressure data were processed with the Novel-Win Multimask analysis software. The purposes of this study were to investigate the biomechanics of dynamic impression insole in plantar pressure and pain reduction.

Enrollment: 50 patients

Sex: All

Ages: 18 to 90 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Adults with metatarsal pain
• Active in walking without any walking aids

Exclusion criteria

• People with flexible flat foot
• Any acute inflammation

Trial design

Primary purpose: Supportive Care

Allocation: Non-Randomized

Interventional model: Factorial Assignment

Masking: None (Open label)

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50 participants in 4 patient groups

Dynamic impression insole

Experimental group

Description:

We sequentially padded P-cell, Ethylene Vinyl Acetate, and Multiform on the 9-mm thick plastazote under daily walking compression to make dynamic impression insole.

Treatment:

Procedure: Dynamic impression insole

Custom molded insole

Experimental group

Description:

The custom molded insole was made by sequentially padded Multiform, P-cell, EVA, and cork on the positive plaster cast impressed by an impression box while holding the subtalar joint at a neutral position.

Treatment:

Procedure: Custom molded insole

9-mm uncompressed Plastazote insole

Experimental group

Description:

We used 9-mm flat Plastazote as an insole

Treatment:

Procedure: 9-mm uncompressed Plastazote

7-mm Ethylene Vinyl Acetate (EVA)

Experimental group

Description:

We used 7-mm flat Ethylene Vinyl Acetate (EVA) as an insole

Treatment:

Procedure: 7-mm Ethylene Vinyl Acetate (EVA)