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Clinical Trials/NCT01629173
NCT01629173
Completed
Early Phase 1

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

Taipei Veterans General Hospital, Taiwan1 site in 1 country50 target enrollmentApril 2011
ConditionsMetatarsalgia

Overview

Phase
Early Phase 1
Intervention
Not specified
Conditions
Metatarsalgia
Sponsor
Taipei Veterans General Hospital, Taiwan
Enrollment
50
Locations
1
Primary Endpoint
Change from baseline in peak plantar pressure value with different insoles
Status
Completed
Last Updated
13 years ago

Overview

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.

Registry
clinicaltrials.gov
Start Date
April 2011
End Date
June 2012
Last Updated
13 years ago
Study Type
Interventional
Study Design
Factorial
Sex
All

Investigators

Responsible Party
Sponsor

Eligibility Criteria

Inclusion Criteria

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

Exclusion Criteria

  • People with flexible flat foot
  • Any acute inflammation

Outcomes

Primary Outcomes

Change from baseline in peak plantar pressure value with different insoles

Time Frame: 4 weeks

We 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 Outcomes

  • Change from baseline in pain levels using Visual Analog Scales(4 weeks)

Study Sites (1)

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