The Analysis and Applications of Dynamic Impression Insole

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Taipei Veterans General Hospital, Taiwan
ClinicalTrials.gov Identifier:
NCT01629173
First received: October 19, 2011
Last updated: June 24, 2012
Last verified: June 2012
  Purpose

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.


Condition Intervention Phase
Metatarsalgia
Procedure: Dynamic impression insole
Procedure: Custom molded insole
Procedure: 9-mm uncompressed Plastazote
Procedure: 7-mm Ethylene Vinyl Acetate (EVA)
Phase 0

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Factorial Assignment
Masking: Open Label
Primary Purpose: Supportive Care
Official Title: The Effect of Dynamic Impression Insoles on Plantar Pressure and Pain in Persons With Metatarsal Pain

Further study details as provided by Taipei Veterans General Hospital, Taiwan:

Primary Outcome Measures:
  • Change from baseline in peak plantar pressure value with different insoles [ Time Frame: 4 weeks ] [ Designated as safety issue: Yes ]
    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 Outcome Measures:
  • Change from baseline in pain levels using Visual Analog Scales [ Time Frame: 4 weeks ] [ Designated as safety issue: Yes ]
    We measure pain levels when using different kinds of insoles by Visual Analog Scales after using dynamic impression insole for four weeks.


Enrollment: 50
Study Start Date: April 2011
Study Completion Date: June 2012
Primary Completion Date: June 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Dynamic impression insole
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.
Procedure: Dynamic 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.
Other Name: dynamic impression insole
Experimental: Custom molded insole
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.
Procedure: Custom 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.
Other Name: custom molded insole
Experimental: 9-mm uncompressed Plastazote insole
We used 9-mm flat Plastazote as an insole
Procedure: 9-mm uncompressed Plastazote
We used 9-mm flat Plastazote(15 Shore A hardness, Schein orthopadie service KG. Remscheid, Germany) as an insole
Other Name: 9-mm uncompressed Plastazote
Experimental: 7-mm Ethylene Vinyl Acetate (EVA)
We used 7-mm flat Ethylene Vinyl Acetate (EVA) as an insole
Procedure: 7-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
Other Name: 7-mm Ethylene Vinyl Acetate (EVA)

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

Ages Eligible for Study:   18 Years to 90 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

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

Exclusion Criteria:

  • People with flexible flat foot
  • Any acute inflammation
  Contacts and Locations
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Please refer to this study by its ClinicalTrials.gov identifier: NCT01629173

Locations
Taiwan
Taipei VGH
Taipei City, Taiwan
Sponsors and Collaborators
Taipei Veterans General Hospital, Taiwan
Investigators
Study Director: Chang Bao-Chi Taipei Veterans General Hospital, Taiwan
  More Information

No publications provided by Taipei Veterans General Hospital, Taiwan

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Taipei Veterans General Hospital, Taiwan
ClinicalTrials.gov Identifier: NCT01629173     History of Changes
Other Study ID Numbers: 97-11-12A
Study First Received: October 19, 2011
Last Updated: June 24, 2012
Health Authority: Taiwan: Department of Health

Keywords provided by Taipei Veterans General Hospital, Taiwan:
plantar pressure
metatarsalgia
insole

Additional relevant MeSH terms:
Metatarsalgia
Foot Diseases
Musculoskeletal Diseases
Joint Diseases
Pain
Neurologic Manifestations
Nervous System Diseases
Signs and Symptoms
Ethylene
Plant Growth Regulators
Growth Substances
Physiological Effects of Drugs
Pharmacologic Actions

ClinicalTrials.gov processed this record on September 29, 2014