Clinical trial NCT01629173: The Analysis and Applications of Dynamic Impression Insole
Official title: The Effect of Dynamic Impression Insoles on Plantar Pressure and Pain in Persons With Metatarsal Pain
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: EARLY_PHASE1
Conditions: Metatarsalgia
Keywords: plantar pressure
metatarsalgia
insole
Lead sponsor: Taipei Veterans General Hospital, Taiwan
Sponsor class: OTHER_GOV
First posted: 2012-06-27
Enrollment: 50
Sex: ALL
Minimum age (years): 18
Maximum age (years): 90
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: FACTORIAL
Primary purpose: SUPPORTIVE_CARE

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.

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

Primary outcomes:
measure: Change from baseline in peak plantar pressure value with different insoles
timeFrame: 4 weeks
Secondary outcomes:
measure: Change from baseline in pain levels using Visual Analog Scales
timeFrame: 4 weeks
Other outcomes:
Locations:
city: Taipei City
country: Taiwan
facility: Taipei VGH
Study officials:
affiliation: Taipei Veterans General Hospital, Taiwan
name: Chang Bao-Chi
role: STUDY_DIRECTOR
References:
citation: Chang BC, Liu DH, Chang JL, Lee SH, Wang JY. Plantar pressure analysis of accommodative insole in older people with metatarsalgia. Gait Posture. 2014;39(1):449-54. doi: 10.1016/j.gaitpost.2013.08.027. Epub 2013 Aug 31.