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The Analysis and Applications of Dynamic Impression Insole

The Effect of Dynamic Impression Insoles on Plantar Pressure and Pain in Persons With Metatarsal Pain

Status
Completed
Phases
Early Phase 1
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT01629173
Enrollment
50
Registered
2012-06-27
Start date
2011-04-30
Completion date
2012-06-30
Last updated
2012-06-27

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Metatarsalgia

Keywords

plantar pressure, metatarsalgia, insole

Brief summary

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.

Detailed 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.

Interventions

PROCEDUREDynamic impression insole

We sequentially padded (1)a 6.5-mm thick P-cell (21 Shore A hardness, Acor orthopedic Inc. Cleveland, Ohio, USA), and (2)a piece of metatarsal pad and arch support made of Ethylene Vinyl Acetate (EVA) (40 Shore A hardness, Schein orthopadie service KG. Remscheid, Germany) to the bottom of the impressed 9-mm thick plastazote (15 Shore A hardness, Schein orthopadie service KG. Remscheid, Germany) with double-sided adhesive tape in the forefoot region and just proximal to the first, second, and third metatarsal head region. We additionally padded a 2-mm thick Multiform (30 Shore A hardness, Schein orthopadie service KG. Remscheid, Germany) on the top of the impressed insole with double-sided adhesive tape.

PROCEDURECustom molded insole

The custom molded insole was made by sequentially padded Multiform (30 Shore A hardness, Schein orthopadie service KG. Remscheid, Germany), P-cell (21 Shore A hardness, Acor orthopedic Inc. Cleveland, Ohio, USA), Ethylene Vinyl Acetate (EVA)(40 Shore A hardness, Schein orthopadie service KG. Remscheid, Germany), and cork (50 Shore A hardness, Schein orthopadie service KG. Remscheid, Germany) on the positive plaster cast impressed by an impression box while holding the subtalar joint at a neutral position.

PROCEDURE9-mm uncompressed Plastazote

We used 9-mm flat Plastazote(15 Shore A hardness, Schein orthopadie service KG. Remscheid, Germany) as an insole

PROCEDURE7-mm Ethylene Vinyl Acetate (EVA)

We used 7-mm flat Ethylene Vinyl Acetate (EVA) (40 Shore A hardness, Schein orthopadie service KG. Remscheid, Germany) as an insole

Sponsors

Taipei Veterans General Hospital, Taiwan
Lead SponsorOTHER_GOV

Study design

Allocation
NON_RANDOMIZED
Intervention model
FACTORIAL
Primary purpose
SUPPORTIVE_CARE
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
18 Years to 90 Years
Healthy volunteers
No

Inclusion criteria

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

Exclusion criteria

* People with flexible flat foot * Any acute inflammation

Design outcomes

Primary

MeasureTime frameDescription
Change from baseline in peak plantar pressure value with different insoles4 weeksWe measure peak pressure (in unit of kPa) under forefoot, midfoot, and rearfoot when using different kinds of insoles by Pedar-X mobile in-shoe system (Novel gmbh, Munich, Germany), and data were processed with the Novel-Win Multimask analysis software (Novel gmbh, Munich, Germany) after using dynamic impression insole for four weeks.

Secondary

MeasureTime frameDescription
Change from baseline in pain levels using Visual Analog Scales4 weeksWe measure pain levels when using different kinds of insoles by Visual Analog Scales after using dynamic impression insole for four weeks.

Countries

Taiwan

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026